Last updated: 11/27/2020 08:50:09
GSK1572932A Antigen-Specific Cancer Immunotherapeutic as adjuvant therapy in patients with Non-Small Cell Lung Cancer
EudraCT ID
EU CT Number
Not applicable
Trial status
Other
Other
Trial overview
Official title: GSK1572932A Antigen-Specific Cancer Immunotherapeutic as adjuvant therapy in patients with resectable MAGE-A3 positive Non-Small Cell Lung Cancer
Trial description: The purpose of this clinical trial is to demonstrate the benefit of the immunotherapeutic product GSK1572932A when given to patients with Non-Small Cell Lung Cancer, after removal of their tumor. A course of 13 injections will be administered over 27 months. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Person year rate (PYAR) as regards disease-free survival (DFS) in the overall population
Timeframe: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Person year rate (PYAR) as regards disease-free survival (DFS) in the No-CT population
Timeframe: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Secondary outcomes:
Person year rate (PYAR) as regards disease-free survival (DFS) in the CT population
Timeframe: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Person year rate (PYAR) as regards overall-survival (OS) in the overall population
Timeframe: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Person year rate (PYAR) as regards overall-survival (OS) in the No-CT population
Timeframe: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Person year rate (PYAR) as regards overall-survival (OS) in the CT population
Timeframe: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Person year rate (PYAR) as regards lung-cancer specific survival (LCSS) in the Overall population
Timeframe: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Person year rate (PYAR) as regards lung-cancer specific survival (LCSS) in the No-CT population
Timeframe: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Person year rate (PYAR) as regards lung-cancer specific survival (LCSS) in the CT population
Timeframe: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Kaplan-Meier estimate (KME) of 2, 3, 4 and 5-year as regards disease-free survival (DFS) in the overall population
Timeframe: KME assessed at 2, 3, 4 and 5-year (Y) post Dose 1 of treatment. Follow-up period was from administration of 1st dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Kaplan-Meier estimate (KME) of 2, 3, 4 and 5-year as regards disease-free survival (DFS) in the No-CT population
Timeframe: KME assessed at 2, 3, 4 and 5-year (Y) post Dose 1 of treatment Follow-up period was from administration of 1st dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Kaplan-Meier estimate (KME) of 2, 3, 4 and 5-year as regards disease-free survival (DFS) in the CT population
Timeframe: KME assessed at 2, 3, 4 and 5-year (Y) post Dose 1 of treatment. Follow-up period was from administration of 1st dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Person year rate (PYAR) as regards disease-free specific survival (DFSS) in the overall population
Timeframe: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Person year rate (PYAR) as regards disease-free specific survival (DFSS) in the No-CT population
Timeframe: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Person year rate (PYAR) as regards disease-free specific survival (DFSS) in the CT population
Timeframe: Period of follow-up was from administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Number of subjects seropositive for anti-Melanoma AntiGEn (MAGE)-A3 antibodies (Anti-MAGE-A3 S+)
Timeframe: Pre-treatment (PRE), at Weeks (W) 6 and 12, at Months (M) 9, 12, 18 and 30 and at one year after treatment concluding time point, i.e. at follow-up visit 2 at W120 added of one year (At 12M post W120)
Number of humoral responders as regards anti-Melanoma AntiGEn (MAGE)-A3 antibodies (Anti-MAGE-A3 HR)
Timeframe: At Weeks (W) 6 and 12, at Months (M) 9, 12, 18 and 30 and at one year after treatment concluding time point, i.e. at follow-up visit 2 at W120 added of one year (at 12M post W120)
Number of subjects seropositive for anti-protein D (PD) antibodies (Anti-PD S+)
Timeframe: Pre-treatment (PRE), at Weeks (W) 6 and 12, at Months (M) 9, 12, 18 and 30 and at one year after treatment concluding time point, i.e. at follow-up visit 2 at W120 added of one year (at 12M post W120)
Number of humoral responders as regards anti-protein D (PD) antibodies (Anti-PD HR)
Timeframe: At Weeks (W) 6 and 12, at Months (M) 9, 12, 18 and 30 and at one year after treatment concluding time point, i.e. at follow-up visit 2 at W120 added of one year (at 12M post W120)
Health-related quality of life (HQL) scores
Timeframe: At Week (W) 0 on day of treatment (DoT) (W0 DoT), W0 on day post treatment (DpT) (W0 DpT), W6 DoT, W6 DpT, W12 DoT, W12 DpT, Month (M) 6, M9, M12, M24, 6M post W120, at recurrence, and at 12M post W120
Number of patients with abnormal alanine aminotransferase (ALT) values by maximum grade
Timeframe: From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Number of patients with abnormal alanine aspartate aminotransferase (AST) values by maximum grade
Timeframe: From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Number of patients with abnormal alkaline phosphatase (ALKP) values by maximum grade
Timeframe: From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Number of patients with abnormal bilirubin (BIL) values by maximum grade
Timeframe: From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Number of patients with abnormal creatinine (CREA) values by maximum grade
Timeframe: From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Number of patients with abnormal haemoglobin (HGB) values by maximum grade
Timeframe: From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Number of patients with abnormal leukocytes (LEU) values by maximum grade
Timeframe: From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Number of patients with abnormal lymphocytes (LYM) values by maximum grade
Timeframe: From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Number of patients with abnormal neutrophils (NEU) values by maximum grade
Timeframe: From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Number of patients with abnormal platelets (PLA) values by maximum grade
Timeframe: From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Number of patients with any adverse events (AEs) and with AEs by maximum grade reported – Up to data lock point (DLP)
Timeframe: Within the 31-day follow-up period post treatment administration, up to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Number of patients with serious adverse events (SAEs) – Up to data lock point (DLP)
Timeframe: From screening (SCR) up to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Interventions:
Enrollment:
2278
Primary completion date:
2013-06-12
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Vansteenkiste JF et al. (2016) Efficacy of the MAGE-A3 cancer immunotherapeutic as adjuvant therapy in patients with resected MAGE-A3-positive non-small-cell lung cancer (MAGRIT): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 17(6):822-835.
Dizier B et al. (2019) A T-helper 1/interferon-ϒ gene signature is prognostic in the adjuvant setting of resectable high-risk melanoma but not in non-small cell lung cancer. Clin Cancer Res. pii: clincanres.3717.2018. doi: 10.1158/1078-0432.CCR-18-3717. [Epub ahead of print].
Medical condition
Lung Cancer, Non-Small Cell
Product
GSK1572932A
Collaborators
Not applicable
Study date(s)
October 2007 to September 2014
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Inclusion criteria:
- Male or female patient with completely resected, pathologically proven stage IB, II or IIIA NSCLC.
Inclusion and exclusion criteria
Inclusion criteria:
- Inclusion criteria:
- Male or female patient with completely resected, pathologically proven stage IB, II or IIIA NSCLC.
- Written informed consent for MAGE-A3 expression screening on tumor biopsy has been obtained from the patient prior to shipment of the sample for expression testing (before or just after surgical resection), and written informed consent for the complete study has been obtained prior to the performance of any other protocol-specific procedure.
- Patient is ≥ 18 years of age at the time of signature of the first informed consent form.
- The patient's tumor shows expression of MAGE-A3 gene
- The surgical technique for resection of the patient's tumor is anatomical, involving at least a lobectomy or a sleeve lobectomy;
- The mediastinal lymph node sampling is done according to study protocol guidelines;
- The patient is free of metastasis, as confirmed by a negative baseline computer tomogram (CT scan) of the chest, upper abdomen and CT scan or MRI of the brain. Other examinations should be performed as clinically indicated. Note that if randomization is taking place within 8 weeks after surgery, brain CT scans or brain MRI performed up to 4 weeks before surgery do not have to be repeated.
- ECOG performance status of 0, 1 or 2 at the time of randomization.
- Adequate bone-marrow reserve, adequate renal function and adequate hepatic function as assessed by standard laboratory criteria, and defined as: Absolute neutrophil count ≥ 1.0 x 10E9/L Platelet count ≥ 75 x 10E9/L Serum creatinine ≤ 1.5 times the Upper Limit of Normal (ULN) ≤ 3.0 times the ULN if due to platinum adjuvant chemotherapy Total bilirubin ≤ 1.5 times the ULN Alanine transaminase (ALAT) ≤ 2.5 times the ULN
- If the patient is female, she must be of non-childbearing potential, i.e. have a current tubal ligation, hysterectomy, ovariectomy or be post menopausal, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to administration of study treatment, have a negative pregnancy test and continue such precautions during all study treatment period and for 2 months after completion of the injection series.
- In the view of the investigator, the patient can and will comply with the requirements of the protocol. Exclusion criteria
- The primary tumor was removed by segmentectomy or wedge resection.
- The patient shows any evidence of residual tumor after surgery.
- The patient has received any anti-cancer specific treatment, including radiotherapy, immunotherapy, chemotherapy or neo-adjuvant chemotherapy, except: For the treatment of previous malignancies as allowed by the protocol (i.e., non-melanoma skin cancers or carcinoma in situ of the cervix or effectively treated malignancy that has been in remission for over 5 years), Administration of adjuvant platinum-based chemotherapy for the treatment of the current NSCLC is allowed between surgery and randomization.
- The patient has previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers or carcinoma in situ of the cervix or effectively treated malignancy that has been in remission for over 5 years and highly likely to have been cured.
- History of allergic disease or reactions likely to be exacerbated by any component of the study investigational product.
- The patient has an autoimmune disease such as, but not limited to, multiple sclerosis, lupus, and inflammatory bowel disease. Patients with vitiligo are not excluded.
- The patient requires concomitant treatment with systemic corticosteroids, or any other immunosuppressive agents. Note: The use of prednisone, or equivalent, <0.5 mg/kg/day (absolute maximum 40 mg/day), or inhaled corticosteroids for COPD or topical steroids is permitted.
- The patient has received a major organ allograft.
- The patient is known to be HIV-positive.
- The patient has an uncontrolled bleeding disorder.
- The patient has uncontrolled congestive heart failure or hypertension, unstable heart disease (coronary artery disease or myocardial infarction) or uncontrolled arrhythmia at the time of enrolment.
- The patient needs home oxygenation.
- The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent, or to comply with the trial procedures.
- The patient has other concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk.
- The patient has received any investigational or non-registered medicinal product other than the study medication within the 30 days preceding the first dose of study medication, or plans to receive such a drug during the study period.
- For female patients: the patient is pregnant or lactating.
Trial location(s)
Location
GSK Investigational Site
São Paulo, São Paulo, Brazil, 01224-010
Status
Study Complete
Location
GSK Investigational Site
Rio de Janeiro, Rio De Janeiro, Brazil, 20230-130
Status
Study Complete
Location
GSK Investigational Site
Louisville, Kentucky, United States, 40245
Status
Study Complete
Location
GSK Investigational Site
Savannah, Georgia, United States, 31405
Status
Study Complete
Location
GSK Investigational Site
Palm Springs, California, United States, 92262
Status
Study Complete
Location
GSK Investigational Site
Dresden, Sachsen, Germany, 01307
Status
Terminated/Withdrawn
Location
GSK Investigational Site
San Sebastian de los Reyes, Spain, 28702
Status
Study Complete
Location
GSK Investigational Site
Leicester, Leicestershire, United Kingdom, LE1 5WW
Status
Study Complete
Location
GSK Investigational Site
Boston, Massachusetts, United States, 02111
Status
Study Complete
Location
GSK Investigational Site
Owensboro, Kentucky, United States, 42303
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Shreveport, Louisiana, United States, 71101
Status
Study Complete
Location
GSK Investigational Site
Marietta, Georgia, United States, 30060
Status
Study Complete
Location
GSK Investigational Site
Rancho Mirage, California, United States, 92270
Status
Study Complete
Location
GSK Investigational Site
Hollywood, Florida, United States, 33021
Status
Study Complete
Location
GSK Investigational Site
Harvey, Illinois, United States, 60426
Status
Study Complete
Location
GSK Investigational Site
Knoxville, Tennessee, United States, 37920
Status
Study Complete
Location
GSK Investigational Site
Vallejo, California, United States, 94589
Status
Study Complete
Location
GSK Investigational Site
Charlotte, North Carolina, United States, 28203
Status
Study Complete
Location
GSK Investigational Site
Bochum, Nordrhein-Westfalen, Germany, 44791
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Montebello, California, United States, 90640
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Spartanburg, South Carolina, United States, 29303
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92121
Status
Study Complete
Location
GSK Investigational Site
Halle (Saale), Sachsen-Anhalt, Germany, 06114
Status
Study Complete
Location
GSK Investigational Site
Alpharetta, Georgia, United States, 30005
Status
Study Complete
Location
GSK Investigational Site
Neuss, Nordrhein-Westfalen, Germany, 41464
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Flushing, New York, United States, 11355
Status
Study Complete
Location
GSK Investigational Site
Seattle, Washington, United States, 98108
Status
Study Complete
Location
GSK Investigational Site
Rosenheim, Bayern, Germany, 83022
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Trier, Rheinland-Pfalz, Germany, 54290
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 50931
Status
Study Complete
Location
GSK Investigational Site
Charlotte, North Carolina, United States, 28204
Status
Study Complete
Location
GSK Investigational Site
São Paulo, São Paulo, Brazil, 01308-050
Status
Study Complete
Location
GSK Investigational Site
Durham, North Carolina, United States, 27705
Status
Study Complete
Location
GSK Investigational Site
Columbia, South Carolina, United States, 29209
Status
Study Complete
Location
GSK Investigational Site
Billings, Montana, United States, 59102
Status
Study Complete
Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46260
Status
Study Complete
Location
GSK Investigational Site
Barretos, São Paulo, Brazil, 14784-400
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90095
Status
Study Complete
Location
GSK Investigational Site
Metairie, Louisiana, United States, 70006
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10065
Status
Study Complete
Location
GSK Investigational Site
Decatur, Illinois, United States, 62526
Status
Study Complete
Location
GSK Investigational Site
Herne, Nordrhein-Westfalen, Germany, 44623
Status
Study Complete
Location
GSK Investigational Site
Grand Rapids, Michigan, United States, 49503
Status
Study Complete
Location
GSK Investigational Site
Tucson, Arizona, United States, 85724
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Augusta, Georgia, United States, 30901
Status
Study Complete
Location
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45136
Status
Study Complete
Location
GSK Investigational Site
Danville, Pennsylvania, United States, 17822
Status
Study Complete
Location
GSK Investigational Site
Orlando, Florida, United States, 32806
Status
Study Complete
Location
GSK Investigational Site
Santo André, São Paulo, Brazil, 09060-650
Status
Study Complete
Location
GSK Investigational Site
Portland, Oregon, United States, 97213
Status
Study Complete
Location
GSK Investigational Site
Luebeck, Schleswig-Holstein, Germany, 23538
Status
Study Complete
Location
GSK Investigational Site
Salt Lake City, Utah, United States, 84106
Status
Study Complete
Location
GSK Investigational Site
Chattanooga, Tennessee, United States, 37421
Status
Study Complete
Location
GSK Investigational Site
Washington, District of Columbia, United States, 20007
Status
Study Complete
Location
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33316
Status
Study Complete
Location
GSK Investigational Site
Scottsdale, Arizona, United States, 85258
Status
Study Complete
Location
GSK Investigational Site
Lansing, Michigan, United States, 48910
Status
Study Complete
Location
GSK Investigational Site
Southfield, Michigan, United States, 48075
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30318
Status
Study Complete
Location
GSK Investigational Site
Grand Island, Nebraska, United States, 68803
Status
Study Complete
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30342
Status
Study Complete
Location
GSK Investigational Site
Charleston, South Carolina, United States, 29414
Status
Study Complete
Location
GSK Investigational Site
Oldenburg, Niedersachsen, Germany, 26121
Status
Study Complete
Location
GSK Investigational Site
Muenster, Nordrhein-Westfalen, Germany, 48149
Status
Study Complete
Location
GSK Investigational Site
Montreal, Québec, Canada, H2L 4M1
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Perth, Western Australia, Australia, 6001
Status
Study Complete
Location
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45122
Status
Study Complete
Location
GSK Investigational Site
West Hollywood, California, United States, 90048
Status
Study Complete
Location
GSK Investigational Site
Lebanon, New Hampshire, United States, 03756
Status
Study Complete
Location
GSK Investigational Site
New Albany, Indiana, United States, 47150
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Pleasant Hill, California, United States, 94523
Status
Study Complete
Location
GSK Investigational Site
Grosshansdorf, Schleswig-Holstein, Germany, 22927
Status
Study Complete
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21201
Status
Study Complete
Location
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30625
Status
Study Complete
Location
GSK Investigational Site
La Jolla, California, United States, 92093
Status
Study Complete
Location
GSK Investigational Site
Braunschweig, Niedersachsen, Germany, 38114
Status
Study Complete
Location
GSK Investigational Site
Burbank, California, United States, 91505
Status
Study Complete
Location
GSK Investigational Site
Armonk, New York, United States, 10504
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Ann Arbor, Michigan, United States, 48109
Status
Study Complete
Location
GSK Investigational Site
Meldola (FC), Emilia-Romagna, Italy, 47014
Status
Study Complete
Location
GSK Investigational Site
Tacoma, Washington, United States, 98405
Status
Study Complete
Location
GSK Investigational Site
Seattle, Washington, United States, 98109
Status
Study Complete
Location
GSK Investigational Site
Everett, Washington, United States, 98201
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92123
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45242
Status
Study Complete
Location
GSK Investigational Site
Greifswald, Mecklenburg-Vorpommern, Germany, 17487
Status
Study Complete
Location
GSK Investigational Site
Hemer, Nordrhein-Westfalen, Germany, 58675
Status
Study Complete
Location
GSK Investigational Site
Honolulu, Hawaii, United States, 96813
Status
Study Complete
Location
GSK Investigational Site
Orange, California, United States, 92868
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Chermside, Queensland, Australia, 4032
Status
Study Complete
Location
GSK Investigational Site
Ashland, Kentucky, United States, 41101
Status
Study Complete
Location
GSK Investigational Site
Porto Alegre, Rio Grande Do Sul, Brazil, 90610 000
Status
Study Complete
Location
GSK Investigational Site
Fairfax, Virginia, United States, 22031
Status
Study Complete
Location
GSK Investigational Site
Nashville, Tennessee, United States, 37203
Status
Study Complete
Location
GSK Investigational Site
Rosario, Santa Fe, Argentina, S2000KZE
Status
Study Complete
Location
GSK Investigational Site
Lancaster, Pennsylvania, United States, 17605
Status
Study Complete
Location
GSK Investigational Site
Frankfurt/Main, Hessen, Germany, 60487
Status
Study Complete
Location
GSK Investigational Site
Detroit, Michigan, United States, 48201
Status
Study Complete
Location
GSK Investigational Site
Udine, Friuli-Venezia-Giulia, Italy, 33100
Status
Study Complete
Location
GSK Investigational Site
Heidelberg, Baden-Wuerttemberg, Germany, 69126
Status
Study Complete
Location
GSK Investigational Site
Fayetteville, Arkansas, United States, 72703
Status
Study Complete
Location
GSK Investigational Site
Buffalo, New York, United States, 14263
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19111
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Cookeville, Tennessee, United States, 38501
Status
Study Complete
Location
GSK Investigational Site
Syracuse, New York, United States, 13210
Status
Study Complete
Location
GSK Investigational Site
West Palm Beach, Florida, United States, 33401
Status
Study Complete
Location
GSK Investigational Site
Ft. Smith, Arkansas, United States, 72917
Status
Study Complete
Location
GSK Investigational Site
Orbassano (TO), Piemonte, Italy, 10043
Status
Study Complete
Location
GSK Investigational Site
Boston, Massachusetts, United States, 02118
Status
Study Complete
Location
GSK Investigational Site
Kiel, Schleswig-Holstein, Germany, 24105
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Memphis, Tennessee, United States, 38104
Status
Study Complete
Location
GSK Investigational Site
St. Louis Park, Minnesota, United States, 55426
Status
Study Complete
Location
GSK Investigational Site
Stanford, California, United States, 94305
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10019
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Waterbury, Connecticut, United States, 06708
Status
Study Complete
Location
GSK Investigational Site
Boca Raton, Florida, United States, 33486
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Towson, Maryland, United States, 21204
Status
Study Complete
Location
GSK Investigational Site
Lapeer, Michigan, United States, 48446
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Grapevine, Texas, United States, 76051
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19140
Status
Study Complete
Location
GSK Investigational Site
Minneapolis, Minnesota, United States, 55455
Status
Study Complete
Location
GSK Investigational Site
Evansville, Indiana, United States, 47713
Status
Study Complete
Location
GSK Investigational Site
Providence, Rhode Island, United States, 02906
Status
Study Complete
Location
GSK Investigational Site
Waldbrol, Nordrhein-Westfalen, Germany, 51545
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Kansas City, Missouri, United States, 64111
Status
Study Complete
Location
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, Germany, 18057
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Freiburg, Baden-Wuerttemberg, Germany, 79106
Status
Study Complete
Location
GSK Investigational Site
Danbury, Connecticut, United States, 06810
Status
Study Complete
Location
GSK Investigational Site
La Jolla, California, United States, 92093-0987
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Weissenfels, Sachsen-Anhalt, Germany, 06667
Status
Study Complete
Location
GSK Investigational Site
Durham, North Carolina, United States, 27710
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10003
Status
Study Complete
Location
GSK Investigational Site
St Catherines, Ontario, Canada, L2S 0A9
Status
Study Complete
Location
GSK Investigational Site
Annapolis, Maryland, United States, 21401
Status
Study Complete
Location
GSK Investigational Site
Colorado Springs, Colorado, United States, 80907
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45267
Status
Study Complete
Location
GSK Investigational Site
Camperdown, New South Wales, Australia, 2050
Status
Study Complete
Location
GSK Investigational Site
Surrey, British Columbia, Canada, V3V 1N1
Status
Study Complete
Location
GSK Investigational Site
Jonesboro, Arkansas, United States, 72401
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10032
Status
Study Complete
Location
GSK Investigational Site
Westmead, New South Wales, Australia, 2145
Status
Study Complete
Location
GSK Investigational Site
Greenville, South Carolina, United States, 29615
Status
Study Complete
Location
GSK Investigational Site
Peoria, Illinois, United States, 61615-7822
Status
Study Complete
Location
GSK Investigational Site
Bethesda, Maryland, United States, 20892-1201
Status
Study Complete
Location
GSK Investigational Site
Langhorne, Pennsylvania, United States, 19047
Status
Study Complete
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21215
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Chicago, Illinois, United States, 60612
Status
Study Complete
Location
GSK Investigational Site
Jacksonville, Florida, United States, 32209
Status
Study Complete
Location
GSK Investigational Site
São Paulo, São Paulo, Brazil, 01509-900
Status
Study Complete
Location
GSK Investigational Site
Sacramento, California, United States, 95816
Status
Study Complete
Location
GSK Investigational Site
Woolloongabba, Queensland, Australia, 4102
Status
Study Complete
Location
GSK Investigational Site
Kansas City, Missouri, United States, 64132
Status
Study Complete
Location
GSK Investigational Site
Park Ridge, Illinois, United States, 60068
Status
Study Complete
Location
GSK Investigational Site
Rochester, Minnesota, United States, 55905
Status
Study Complete
Location
GSK Investigational Site
Mobile, Alabama, United States, 36604
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Koblenz, Rheinland-Pfalz, Germany, 56068
Status
Study Complete
Location
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53226
Status
Study Complete
Location
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1430CLD
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Chicago, Illinois, United States, 60611
Status
Study Complete
Location
GSK Investigational Site
Detroit, Michigan, United States, 48202
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10016
Status
Study Complete
Location
GSK Investigational Site
Scottsdale, Arizona, United States, 85259
Status
Study Complete
Location
GSK Investigational Site
San Francisco, California, United States, 94107
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21237
Status
Study Complete
Location
GSK Investigational Site
Edinburgh, Midlothian, United Kingdom, EH4 2XU
Status
Study Complete
Location
GSK Investigational Site
Bielefeld, Nordrhein-Westfalen, Germany, 33611
Status
Study Complete
Location
GSK Investigational Site
C.A.B.A., Buenos Aires, Argentina, C1425EHD
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Alexandria, Louisiana, United States, 71301
Status
Study Complete
Location
GSK Investigational Site
Bay City, Michigan, United States, 48706
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Vancouver, Washington, United States, 98664
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19104
Status
Study Complete
Location
GSK Investigational Site
Bethlehem, Pennsylvania, United States, 18015
Status
Study Complete
Location
GSK Investigational Site
Velbert, Nordrhein-Westfalen, Germany, 42551
Status
Study Complete
Location
GSK Investigational Site
Coeur d'Alene, Idaho, United States, 83814
Status
Study Complete
Location
GSK Investigational Site
Bielefeld, Nordrhein-Westfalen, Germany, 33604
Status
Study Complete
Location
GSK Investigational Site
Greenbrae, California, United States, 94904-2007
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Frankfurt/Oder, Brandenburg, Germany, 15236
Status
Study Complete
Location
GSK Investigational Site
Cambridge, Cambridgeshire, United Kingdom, CB2 2RE
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Torrington, Connecticut, United States, 06790
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Usti nad Labem, Czech Republic, 401 12
Status
Study Complete
Location
GSK Investigational Site
Worcester, Massachusetts, United States, 01608
Status
Study Complete
Location
GSK Investigational Site
Sacramento, California, United States, 95817
Status
Study Complete
Location
GSK Investigational Site
St. Louis Park, Minnesota, United States, 55416
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Round Rock, Texas, United States, 78665
Status
Study Complete
Location
GSK Investigational Site
Ostercappeln, Niedersachsen, Germany, 49179
Status
Study Complete
Location
GSK Investigational Site
Ulm, Baden-Wuerttemberg, Germany, 89081
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Moers, Nordrhein-Westfalen, Germany, 47441
Status
Study Complete
Location
GSK Investigational Site
Worcester, Massachusetts, United States, 01605
Status
Study Complete
Location
GSK Investigational Site
South Brisbane, Queensland, Australia, 4101
Status
Study Complete
Location
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
Status
Study Complete
Location
GSK Investigational Site
Springfield, Illinois, United States, 62794-9638
Status
Study Complete
Location
GSK Investigational Site
Muenster, Nordrhein-Westfalen, Germany, 48153
Status
Study Complete
Location
GSK Investigational Site
Madison, Wisconsin, United States, 53792
Status
Study Complete
Location
GSK Investigational Site
Oberhausen, Nordrhein-Westfalen, Germany, 46145
Status
Study Complete
Location
GSK Investigational Site
Mineola, New York, United States, 11501
Status
Study Complete
Location
GSK Investigational Site
Silver Spring, Maryland, United States, 20902
Status
Study Complete
Location
GSK Investigational Site
Sayre, Pennsylvania, United States, 18840
Status
Study Complete
Location
GSK Investigational Site
Munster, Indiana, United States, 46321
Status
Study Complete
Location
GSK Investigational Site
Newark, Delaware, United States, 19713
Status
Study Complete
Location
GSK Investigational Site
Knoxville, Tennessee, United States, 37905
Status
Study Complete
Location
GSK Investigational Site
Henderson, Nevada, United States, 89052
Status
Study Complete
Location
GSK Investigational Site
Fresno, California, United States, 93720
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15212
Status
Study Complete
Location
GSK Investigational Site
Duarte, California, United States, 91010
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Nedlands, Western Australia, Australia, 6009
Status
Study Complete
Location
GSK Investigational Site
Boston, Massachusetts, United States, 02114
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35294-3300
Status
Study Complete
Location
GSK Investigational Site
Belo Horizonte, Minas Gerais, Brazil, 30730-540
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10011
Status
Study Complete
Location
GSK Investigational Site
Wilkes-Barre, Pennsylvania, United States, 18702
Status
Study Complete
Location
GSK Investigational Site
Memphis, Tennessee, United States, 38120
Status
Study Complete
Location
GSK Investigational Site
Adelaide, South Australia, Australia, 5000
Status
Study Complete
Location
GSK Investigational Site
Lexington, Kentucky, United States, 40503
Status
Study Complete
Location
GSK Investigational Site
Cipolletti, Río Negro, Argentina, R8324EMB
Status
Study Complete
Location
GSK Investigational Site
Orlando, Florida, United States, 32804
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15232
Status
Study Complete
Location
GSK Investigational Site
Providence, Rhode Island, United States, 02903
Status
Study Complete
Location
GSK Investigational Site
Waratah, New South Wales, Australia, 2298
Status
Study Complete
Location
GSK Investigational Site
Deerfield Beach, Florida, United States, 33064
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Troisdorf, Nordrhein-Westfalen, Germany, 53840
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85013
Status
Study Complete
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21204
Status
Study Complete
Location
GSK Investigational Site
Santa Rosa, California, United States, 95403-1757
Status
Study Complete
Location
GSK Investigational Site
Beverly Hills, California, United States, 90211
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30322
Status
Study Complete
Location
GSK Investigational Site
Tyler, Texas, United States, 75708-3154
Status
Study Complete
Location
GSK Investigational Site
Spokane, Washington, United States, 99208
Status
Study Complete
Location
GSK Investigational Site
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1125ABD
Status
Study Complete
Location
GSK Investigational Site
Wangen, Baden-Wuerttemberg, Germany, 88239
Status
Study Complete
Location
GSK Investigational Site
Saint Louis, Missouri, United States, 63110
Status
Study Complete
Location
GSK Investigational Site
Chapel Hill, North Carolina, United States, 27599-7065
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63110
Status
Study Complete
Location
GSK Investigational Site
Garran, Australian Capital Territory, Australia, 2606
Status
Study Complete
Location
GSK Investigational Site
Seattle, Washington, United States, 98104
Status
Study Complete
Location
GSK Investigational Site
Greenville, North Carolina, United States, 27834
Status
Study Complete
Location
GSK Investigational Site
Zwickau, Sachsen, Germany, 08058
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Aurora, Colorado, United States, 80045
Status
Study Complete
Location
GSK Investigational Site
Wythenshawe, Greater Manchester, United Kingdom, M23 9LT
Status
Study Complete
Location
GSK Investigational Site
Mulheim, Nordrhein-Westfalen, Germany, 45473
Status
Study Complete
Location
GSK Investigational Site
Luedenscheid, Nordrhein-Westfalen, Germany, 58515
Status
Study Complete
Location
GSK Investigational Site
Springfield, Missouri, United States, 65804
Status
Study Complete
Location
GSK Investigational Site
Roanoke, Virginia, United States, 24014
Status
Study Complete
Location
GSK Investigational Site
Hazard, Kentucky, United States, 41701
Status
Study Complete
Location
GSK Investigational Site
Greenfield Park, Québec, Canada, J4V 2H1
Status
Study Complete
Location
GSK Investigational Site
Minneapolis, Minnesota, United States, 55407-3799
Status
Study Complete
Location
GSK Investigational Site
Long Branch, New Jersey, United States, 07740
Status
Study Complete
Location
GSK Investigational Site
Tweed Heads, New South Wales, Australia, 2485
Status
Study Complete
Location
GSK Investigational Site
Evanston, Illinois, United States, 60201
Status
Study Complete
Location
GSK Investigational Site
Dayton, Ohio, United States, 45429
Status
Terminated/Withdrawn
Location
GSK Investigational Site
East Syracuse, New York, United States, 13057
Status
Study Complete
Location
GSK Investigational Site
Paramus, New Jersey, United States, 07652
Status
Study Complete
Location
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 51109
Status
Study Complete
Location
GSK Investigational Site
Boynton Beach, Florida, United States, 33435
Status
Study Complete
Location
GSK Investigational Site
Bakersfield, California, United States, 93309
Status
Study Complete
Location
GSK Investigational Site
Sutton, Surrey, United Kingdom, SM2 5PT
Status
Study Complete
Location
GSK Investigational Site
Porta Westfalica, Nordrhein-Westfalen, Germany, 32457
Status
Study Complete
Location
GSK Investigational Site
Bonn, Nordrhein-Westfalen, Germany, 53113
Status
Study Complete
Location
GSK Investigational Site
Chicago, Illinois, United States, 60637
Status
Study Complete
Location
GSK Investigational Site
Sumter, South Carolina, United States, 29150
Status
Study Complete
Location
GSK Investigational Site
Palo Alto, California, United States, 94304
Status
Study Complete
Location
GSK Investigational Site
Charleston, South Carolina, United States, 29425
Status
Study Complete
Location
GSK Investigational Site
Willow Grove, Pennsylvania, United States, 19090
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Villingen-Schwenningen, Baden-Wuerttemberg, Germany, 78050
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Other
Actual primary completion date
2013-06-12
Actual study completion date
2014-23-09
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Participate in clinical trial
Additional information
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