Last updated: 11/04/2018 06:27:11
This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study. The most up to date information is available on clinicaltrials.gov.
Tykerb Evaluation After Chemotherapy (TEACH): Lapatinib Versus Placebo In Women with Early-Stage Breast Cancer
EudraCT ID
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Trial overview
Official title: A Randomized, Double-blind, Multicenter, Placebo-controlled Study of Adjuvant Lapatinib (GW572016) in Women with Early-Stage ErbB2 Overexpressing Breast Cancer
Trial description: This study was designed to evaluate and compare the safety and efficacy of an oral dual tyrosine kinase inhibitor, lapatinib, versus placebo in women with early-stage ErbB2-overexpressing breast cancer who have completed their primary neoadjuvant or adjuvant chemotherapy and have no clinical or radiographic evidence of disease.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Allocation:
Randomized
Primary outcomes:
Number of participants (par.) with any recurrence of the initial disease, second primary cancer, contralateral breast cancer, or death (disease-free survival [DFS])
Timeframe: From randomization until date of the first occurrence of an objective disease recurrence, a second primary cancer, or death from any cause (assessed up to 6 years; 1 year of treatment, 5 years of follow-up [median of 5.3 years for final analysis])
Secondary outcomes:
Number of participants who died (overall survival)
Timeframe: From the date of randomization until death from any cause (assessed up to 6 years; 1 year of treatment and 5 years of follow-up [median of 5.3 years for final analysis])
Percentage of participants with the indicated period of recurrence-free survival (time to first recurrence)
Timeframe: From the date of randomization until the date of the first occurrence of an objective disease recurrence or contralateral breast cancer (assessed up to 6 years; 1 year of treatment and 5.3 years of follow-up [median of 5 years for final analysis])
Percentage of participants with the indicated period of distant recurrence-free survival (time to distant recurrence)
Timeframe: From the date of randomization until the date of the first occurrence of a distant recurrence (assessed up to 6 years; 1 year of treatment and 5 years of follow-up [median of 5.3 years for final analysis])
Time to central nervous system (CNS) recurrence
Timeframe: From the date of randomization until the date of the first occurrence of a CNS recurrence (assessed up to 6 years [1 year of treatment and 5 years of follow-up; median of 5.3 years for final analysis])
Number of participants with CNS recurrence
Timeframe: From the date of randomization until the date of the first occurrence of a CNS recurrence (assessed up to 6 years [1 year of treatment and 5 years of follow-up; median of 5.3 years for final analysis])
Modified disease-free survival (MDFS)
Timeframe: From the date of randomization until the date of the first occurrence of an objective disease recurrence, contralateral breast cancer, or death from any cause (assessed up to 6 years)
Number of participants with any recurrence of the initial disease, contralateral breast cancer, or death (disease-free survival [DFS])
Timeframe: From the date of randomization until the date of the first occurrence of an objective disease recurrence, contralateral breast cancer, or death from any cause (assessed up to 6 years)
Change from Baseline in Short Form-36 version 2 (SF-36 v2) scores for the physical component summary (PCS)
Timeframe: Baseline, Month 6, Month 12, and every 6 months after discontinuation of study treatment for 24 months (up to a maximum of 3 study years)
Change from Baseline in SF-36 v2 scores for the mental component summary (MCS)
Timeframe: Baseline, Month 6, Month 12, and every 6 months after discontinuation of study treatment for 24 months (up to a maximum of 3 study years)
Change from Baseline in the SF-36 v2 domain scores for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH)
Timeframe: Baseline, Month 6, Month 12, and every 6 months after discontinuation of study treatment for 24 months (up to a maximum of 3 study years)
Number of participants with hematology values outside the reference range for the indicated parameters
Timeframe: At Baseline and every 3 months thereafter up to Month 12/Early Withdrawal Visit
Number of participants with clinical chemistry values outside the reference range for the indicated parameters
Timeframe: At Baseline and every 6 weeks thereafter up to Month 12/Early Withdrawal Visit
Number of participants with non-laboratory toxicities of the indicated toxicity grades
Timeframe: From the first dose of study treatment up to 12 months
Number of participants experiencing primary or secondary cardiac events
Timeframe: From the date of randomization up to 12 months
Number of participants with the indicated electrocardiogram (ECG) findings
Timeframe: Screening and Month 12/Early Withdrawal Visit
Interventions:
Enrollment:
3166
Primary completion date:
2011-21-09
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
P Goss, I Smith, J O’Shaughnessy, B Ejlertsen, M Kaufmann, F Boyle, A Buzdar, P Fumoleau, W Gradishar, M Martin, B Moy, M Piccart-Gebhart, K I Pritchard, D Lindquist, Y Chavarri-Guerra, G Aktan, E Rappold, L S Williams, D M Finkelstein. Resubmission: A Randomized Trial of Adjuvant Lapatinib in Women with Early Stage HER2 Overexpressing Breast Cancer. Lancet Oncol. 2012;S 1470-2045(12):70508-9.
FM Boyle, IE Smith, J O’Shaughnessy, B Ejlertsen, M Kaufmann, AU Buzdar, P Fumoleau, W Gradishar, M Martin, B Moy, M Piccart-Gebhart, KI Pritchard, D Lindquist, M Amonkar, Y Huang, E Rappold, LS Williams, J Wang-Silvanto, T Kaneko, DM Finkelstein, PE Goss.Health Related Quality of Life of women in TEACH, a randomized placebo controlled adjuvant trial of lapatinib in Early Stage Human Epidermal Growth Factor Receptor (HER2) Overexpressing Breast Cancer .Eur J Cancer.2015;Epub ahead of print
P Goss, I Smith, J O’Shaughnessy, B Ejlertsen, M Kaufmann, F Boyle, A Buzdar, P Fumoleau, W Gradishar, M Martin, B Moy, M Piccart-Gebhart, K I Pritchard, D Lindquist, Y Chavarri-Guerra, G Aktan, E Rappold, L S Williams, D M Finkelstein.Resubmission: A Randomized Trial of Adjuvant Lapatinib in Women with Early Stage HER2 Overexpressing Breast Cancer.Lancet Oncol.2013;14(1):88-96
Medical condition
Neoplasms, Breast
Product
lapatinib
Collaborators
Not applicable
Study date(s)
August 2006 to July 2013
Type
Interventional
Phase
3
Participation criteria
Sex
Female
Age
18+ years
Accepts healthy volunteers
No
- Have histologically or cytologically confirmed ErbB2-overexpressing invasive carcinoma (TX or T1-4) of the breast at the time of the initial diagnosis and have undergone adequate excision of tumor;
- Had tumors that overexpress ErbB2 defined as 3+ by IHC or c-erbB2 gene amplification by FISH (ErbB2 expression/amplification must be documented prior to study entry; however, a tumor tissue sample must be sent to a central laboratory for subsequent re-analysis of ErbB2 status);
- Have clinical and radiologic evidence of local or regional recurrence of disease or metastatic disease at the time of study entry;
- Had metachronous invasive breast cancer (breast cancers diagnosed at different times);
Inclusion and exclusion criteria
Inclusion criteria:
- Have histologically or cytologically confirmed ErbB2-overexpressing invasive carcinoma (TX or T1-4) of the breast at the time of the initial diagnosis and have undergone adequate excision of tumor;
- Had tumors that overexpress ErbB2 defined as 3+ by IHC or c-erbB2 gene amplification by FISH (ErbB2 expression/amplification must be documented prior to study entry; however, a tumor tissue sample must be sent to a central laboratory for subsequent re-analysis of ErbB2 status);
- Have Stage I through Stage IIIc disease according to the American Joint Committee on Cancer (6th edition) staging criteria for breast cancer and meet one of the following criteria: node-positive disease defined as: one positive lymph node by sentinel node biopsy OR at least 1 positive lymph node found among at least 6 axillary nodes examined on axillary node dissection OR status post axillary radiotherapy for sterilization if clinically evaluated as cN1 or cN2 (if sentinel node biopsy is positive, subject may either undergo an axillary node dissection or radiotherapy to the axilla). node-positive disease evaluated as: ipsilateral axillary lymph nodes cN0-2 by clinical evaluation and axillary lymph nodes pNX, pN0(i+), or pN1-3 by pathological evaluation [patients with pN3 (Stage IIIc disease) must be disease free following completion of neoadjuvant or adjuvant chemotherapy for at least 12 months and must not have been lost to follow up]. OR node-negative disease defined as: negative sentinel node biopsy OR no positive lymph nodes found among at least 6 axillary nodes examined on axillary node dissection OR status post axillary radiotherapy for sterilization if clinically evaluated as cN0. node-negative disease categorized as: high-risk disease (tumor >2.0 cm if ER and/or progesterone receptor (PgR) positive disease is present or tumor >1.0 cm if ER and PgR negative disease) OR intermediate-risk disease (tumor 1.0-2.0 cm and ER and/or PgR positive disease).
- Women with synchronous bilateral invasive breast cancer or synchronous DCIS of either the contralateral or ipsilateral breast at the time of the initial diagnosis are also eligible;
- Have undergone either mastectomy OR lumpectomy;
- Have received and completed treatment with a neoadjuvant or adjuvant chemotherapy regimen containing either an anthracycline or a taxane; or any cyclophosphamide, methotrexate and 5-fluorouracil (CMF) regimen;
- May continue to receive endocrine therapy while taking study medication, if endocrine therapy was initiated as either adjuvant therapy for treatment of the initial diagnosis of invasive breast cancer or for ovarian function suppression; however, endocrine therapy may not be initiated while taking study medication. Endocrine therapy agents may be switched while participating in this study (e.g., stop tamoxifen and start letrozole);
- May have received prior radiotherapy as treatment for primary tumor; however, is not required for study entry;
- May continue to receive radiotherapy while taking study medication, if radiotherapy was initiated as adjuvant therapy for treatment of the initial diagnosis of invasive breast cancer;
- May continue to receive bisphosphonates only for treatment of documented osteoporosis, but not as treatment or prophylaxis of bone metastases;
- All women eligible for adjuvant treatment with trastuzumab, including those diagnosed and treated within the last six months, must be considered for such treatment prior to being offered participation in this study. Participation in this study will be allowed only if the physician and patient have considered and discussed at length the advantages of trastuzumab, but have mutually decided against initiating trastuzumab therapy.
- Have clinical and radiologic assessments that are negative for local or regional recurrence of disease or metastatic disease at the time of study entry;
- if signs or symptoms suggestive of either recurrence of disease or metastatic disease are present, the appropriate radiological imaging must be performed
- if the following laboratory results are present, the appropriate radiological imaging must be performed:
- for AST/ALT ≥2×ULN or ALP ≥2×ULN (not in the bone fraction), an abdominal CT or MRI must be done
- for ALP≥2×ULN in the bone fraction, a bone scan must be done; a confirmatory x-ray, CT scan or MRI scan or biopsy is required if the results of the bone scan are inconclusive
- Have a unilateral/bilateral mammogram within 12 months prior to study entry;
- Have an analysis of both ER and PgR on the primary tumor prior to study entry;
- Have a cardiac ejection fraction within institutional range of normal as measured by either echocardiogram or multigated acquisition scans;
- Have an Eastern Cooperative Oncology Group Performance Status of 0 to 1;
- Women with a history of non-breast malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence. Women with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical carcinoma in situ, melanoma in situ, and basal cell or squamous cell carcinoma of the skin;
- Are able to swallow and retain oral medication;
- Have a paraffin-embedded tissue block from an archived tumor tissue from the primary tumor or twenty (20) slides of paraffin-embedded tissue available for biomarker analysis;
- Have adequate organ function defined as: absolute neutrophil count ≥1.5× 10^9/L; hemoglobin ≥9 g/dL; platelets ≥75 × 10^9/L; albumin ≥2.5 g/dL; serum bilirubin ≤1.25 ×ULN; aspartate aminotransferase and alanine aminotransferase ≤3 × ULN and serum creatinine ≤2.0 mg/dL or calculated creatinine clearance ≥40 mL/min
- Have signed the informed consent form (ICF);
- Women of child-bearing potential must have a negative serum pregnancy test at screening and agree to complete abstinence from intercourse or consistent and correct use of an acceptable methods of birth control from 2 weeks prior to administration of the first dose of study medication until 28 days after the final dose of study medication:
Exclusion criteria:
- Have clinical and radiologic evidence of local or regional recurrence of disease or metastatic disease at the time of study entry;
- Had metachronous invasive breast cancer (breast cancers diagnosed at different times);
- Have a prior history of other breast cancer malignancies, including DCIS;
- Are unable to provide archived tumor tissue samples for assay;
- Had prior therapy with an ErbB1 and/or ErbB2 inhibitor; women who experienced a hypersensitivity or allergic reaction to trastuzumab during the first infusion and were unable to complete this infusion are eligible;
- Receive concurrent anti-cancer therapy (chemotherapy, immunotherapy, and biologic therapy) while taking study medication;
- Have unresolved or unstable, serious toxicity from prior administration of another investigational drug and/or of prior cancer treatment;
- Have malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Women with ulcerative colitis are also excluded;
- Have a concurrent disease or condition that would make the woman inappropriate for study participation, or any serious medical disorder that would interfere with the woman's safety;
- Have an active or uncontrolled infection;
- Have dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent;
- Have a known history of uncontrolled or symptomatic angina, arrhythmias, or CHF;
- Are pregnant or breastfeeding;
- Receive concurrent treatment with an investigational agent; women, who are in follow-up in another clinical trial where the primary endpoint has been met and the interval between assessments is ≥12 months and radiological imaging is not required at these assessments, are eligible;
- Receive concurrent treatment with a selected list of strong inducers and inhibitors of CYP3A4;
- Used an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of study medication;
- Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to lapatinib or excipients;
Trial location(s)
Location
GSK Investigational Site
Columbia, Missouri, United States, 65201
Status
Terminated/Withdrawn
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Study Complete
Location
GSK Investigational Site
Frankfurt am Main, Hessen, Germany, 60590
Status
Study Complete
Location
GSK Investigational Site
Drexel Hill, Pennsylvania, United States, 19026
Status
Study Complete
Location
GSK Investigational Site
Washington, District of Columbia, United States, 20010
Status
Study Complete
Location
GSK Investigational Site
Edgbaston, Birmingham, United Kingdom, B15 2TH
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85012
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Port St. Lucie, Florida, United States, 34952
Status
Study Complete
Location
GSK Investigational Site
Heidelberg, Baden-Wuerttemberg, Germany, 69115
Status
Study Complete
Location
GSK Investigational Site
Scarborough, Maine, United States, 4074
Status
Study Complete
Location
GSK Investigational Site
Darlinghurst, New South Wales, Australia, 2010
Status
Study Complete
Location
GSK Investigational Site
Frankfurt, Hessen, Germany, 65929
Status
Terminated/Withdrawn
Location
GSK Investigational Site
East Melbourne, Victoria, Australia, 3002
Status
Study Complete
Location
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30625
Status
Study Complete
Location
GSK Investigational Site
Middletown, Ohio, United States, 45042
Status
Study Complete
Location
GSK Investigational Site
Hildesheim, Niedersachsen, Germany, 31134
Status
Study Complete
Location
GSK Investigational Site
Stendal, Sachsen-Anhalt, Germany, 39576
Status
Study Complete
Location
GSK Investigational Site
Kansas City, Missouri, United States, 64118
Status
Study Complete
Location
GSK Investigational Site
Memphis, Tennessee, United States, 38120
Status
Study Complete
Location
GSK Investigational Site
Sioux City, Iowa, United States, 51101-1733
Status
Study Complete
Location
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1185AAT
Status
Study Complete
Location
GSK Investigational Site
Fairfax, Virginia, United States, 22031
Status
Study Complete
Location
GSK Investigational Site
Richland, Virginia, United States, 24641
Status
Study Complete
Location
GSK Investigational Site
Bedford Park, South Australia, Australia, 5042
Status
Study Complete
Location
GSK Investigational Site
Muelheim, Nordrhein-Westfalen, Germany, 45473
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63141
Status
Study Complete
Location
GSK Investigational Site
Athlone Park, Amanzimtoti, South Africa, 4126
Status
Study Complete
Location
GSK Investigational Site
Herne, Nordrhein-Westfalen, Germany, 44623
Status
Study Complete
Location
GSK Investigational Site
Robbinsdale, Minnesota, United States, 55422
Status
Study Complete
Location
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 50677
Status
Study Complete
Location
GSK Investigational Site
Nedlands, Western Australia, Australia, 6009
Status
Study Complete
Location
GSK Investigational Site
Chicago, Illinois, United States, 60611-2906
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Louisville, Kentucky, United States, 40245
Status
Study Complete
Location
GSK Investigational Site
Homburg/Saar, Saarland, Germany, 66421
Status
Study Complete
Location
GSK Investigational Site
Magdeburg, Sachsen-Anhalt, Germany, 39108
Status
Study Complete
Location
GSK Investigational Site
Sutton, Surrey, United Kingdom, SM2 5PT
Status
Study Complete
Location
GSK Investigational Site
Park Ridge, Illinois, United States, 60068
Status
Study Complete
Location
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
Status
Study Complete
Location
GSK Investigational Site
Boca Raton, Florida, United States, 33428
Status
Study Complete
Location
GSK Investigational Site
Washington, District of Columbia, United States, 20007
Status
Study Complete
Location
GSK Investigational Site
Saint Louis, Missouri, United States, 63109
Status
Study Complete
Location
GSK Investigational Site
Bochum, Nordrhein-Westfalen, Germany, 44799
Status
Study Complete
Location
GSK Investigational Site
Cleveland, Ohio, United States, 44195
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Boston, Massachusetts, United States, 02114
Status
Study Complete
Location
GSK Investigational Site
Elizabeth Vale, South Australia, Australia, 5112
Status
Study Complete
Location
GSK Investigational Site
Orlando, Florida, United States, 32806
Status
Study Complete
Location
GSK Investigational Site
Kalamazoo, Michigan, United States, 49048
Status
Study Complete
Location
GSK Investigational Site
Magdeburg, Sachsen-Anhalt, Germany, 39104
Status
Study Complete
Location
GSK Investigational Site
Goyang-si, Gyeonggi-do, South Korea, 410-769
Status
Study Complete
Location
GSK Investigational Site
Tygerberg, Western Province, South Africa, 7505
Status
Study Complete
Location
GSK Investigational Site
Ringwood East, Victoria, Australia, 3135
Status
Study Complete
Location
GSK Investigational Site
Muenchen, Bayern, Germany, 81377
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Edina, Minnesota, United States, 55435
Status
Study Complete
Location
GSK Investigational Site
Denver, Colorado, United States, 80220
Status
Study Complete
Location
GSK Investigational Site
Greenfield Park, Québec, Canada, J4V 2H1
Status
Study Complete
Location
GSK Investigational Site
North Sydney, New South Wales, Australia, 2060
Status
Study Complete
Location
GSK Investigational Site
Woodville, South Australia, Australia, 5011
Status
Study Complete
Location
GSK Investigational Site
Round Rock, Texas, United States, 78681
Status
Study Complete
Location
GSK Investigational Site
Capital Federal, Buenos Aires, Argentina, C1405CUB
Status
Study Complete
Location
GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany, 68161
Status
Study Complete
Location
GSK Investigational Site
Liverpool, New South Wales, Australia, 2170
Status
Study Complete
Location
GSK Investigational Site
Porta Westfalica, Nordrhein-Westfalen, Germany, 32457
Status
Study Complete
Location
GSK Investigational Site
Ciudad Autónoma de Buenos Aires, Argentina, C1417DTN
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Chelmsford, Essex, United Kingdom, CM1 7ET
Status
Study Complete
Location
GSK Investigational Site
Gainesville, Florida, United States, 32605
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10003
Status
Study Complete
Location
GSK Investigational Site
Chesapeake, Virginia, United States, 23320
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10016
Status
Study Complete
Location
GSK Investigational Site
Paramus, New Jersey, United States, 07652
Status
Study Complete
Location
GSK Investigational Site
Perth, Western Australia, Australia, 6000
Status
Study Complete
Location
GSK Investigational Site
Fort Worth, Texas, United States, 76104
Status
Terminated/Withdrawn
Location
GSK Investigational Site
New Port Richey, Florida, United States, 34655
Status
Study Complete
Location
GSK Investigational Site
Rio de Janeiro, Rio De Janeiro, Brazil, 21941-913
Status
Study Complete
Location
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile, 7591046
Status
Terminated/Withdrawn
Location
GSK Investigational Site
East Setauket, New York, United States, 11733
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Santo Andre, São Paulo, Brazil, 09060-670
Status
Study Complete
Location
GSK Investigational Site
Hickory, North Carolina, United States, 28602
Status
Study Complete
Location
GSK Investigational Site
La Verne, California, United States, 91750
Status
Study Complete
Location
GSK Investigational Site
Kogarah, New South Wales, Australia, 2217
Status
Study Complete
Location
GSK Investigational Site
Chattanooga, Tennessee, United States, 37403
Status
Study Complete
Location
GSK Investigational Site
songpa-gu, Seoul, South Korea, 138-736
Status
Study Complete
Location
GSK Investigational Site
Morristown, New Jersey, United States, 07962
Status
Study Complete
Location
GSK Investigational Site
Mount Kisco, New York, United States, 10590
Status
Study Complete
Location
GSK Investigational Site
Hilden, Nordrhein-Westfalen, Germany, 40724
Status
Study Complete
Location
GSK Investigational Site
Yakima, Washington, United States, 98902
Status
Study Complete
Location
GSK Investigational Site
Luebeck, Schleswig-Holstein, Germany, 23538
Status
Study Complete
Location
GSK Investigational Site
Marrero, Louisiana, United States, 70072
Status
Study Complete
Location
GSK Investigational Site
Stuttgart, Baden-Wuerttemberg, Germany, 70190
Status
Study Complete
Location
GSK Investigational Site
Rosario, Santa Fe, Argentina, S2000KZE
Status
Study Complete
Location
GSK Investigational Site
Duisburg, Nordrhein-Westfalen, Germany, 47166
Status
Study Complete
Location
GSK Investigational Site
Rancho Mirage, California, United States, 92270
Status
Study Complete
Location
GSK Investigational Site
Stuttgart, Baden-Wuerttemberg, Germany, 70376
Status
Study Complete
Location
GSK Investigational Site
Salzgitter, Niedersachsen, Germany, 38226
Status
Study Complete
Location
GSK Investigational Site
St. Joseph, Missouri, United States, 64507
Status
Study Complete
Location
GSK Investigational Site
Freiburg, Baden-Wuerttemberg, Germany, 79106
Status
Study Complete
Location
GSK Investigational Site
Cherry Hill, New Jersey, United States, 08003
Status
Study Complete
Location
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 50937
Status
Study Complete
Location
GSK Investigational Site
Rosenheim, Bayern, Germany, 83022
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Duesseldorf, Nordrhein-Westfalen, Germany, 40235
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bethesda, Maryland, United States, 20817
Status
Study Complete
Location
GSK Investigational Site
Fayetteville, Arkansas, United States, 72703
Status
Study Complete
Location
GSK Investigational Site
Fuerstenwalde, Brandenburg, Germany, 15517
Status
Study Complete
Location
GSK Investigational Site
Saskatoon, Saskatchewan, Canada, S7N 4H4
Status
Study Complete
Location
GSK Investigational Site
Charleston, South Carolina, United States, 29414
Status
Study Complete
Location
GSK Investigational Site
Campbelltown, New South Wales, Australia, 2560
Status
Study Complete
Location
GSK Investigational Site
Saxonwold, Johannesburg, South Africa, 2196
Status
Study Complete
Location
GSK Investigational Site
Charleston, North Carolina, United States, 29406
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Piacenza, Emilia-Romagna, Italy, 29100
Status
Study Complete
Location
GSK Investigational Site
Albany, New York, United States, 12206
Status
Study Complete
Location
GSK Investigational Site
Saarbruecken, Saarland, Germany, 66113
Status
Study Complete
Location
GSK Investigational Site
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Status
Study Complete
Location
GSK Investigational Site
La Jolla, California, United States, 92037
Status
Study Complete
Location
GSK Investigational Site
Gastonia, North Carolina, United States, 28054
Status
Study Complete
Location
GSK Investigational Site
Gilroy, California, United States, 95020
Status
Study Complete
Location
GSK Investigational Site
Porto Alegre, Rio Grande Do Sul, Brazil, 90610 000
Status
Study Complete
Location
GSK Investigational Site
Newton, Massachusetts, United States, 02462
Status
Study Complete
Location
GSK Investigational Site
Konstanz, Baden-Wuerttemberg, Germany, 78464
Status
Study Complete
Location
GSK Investigational Site
Ulm, Baden-Wuerttemberg, Germany, 89075
Status
Study Complete
Location
GSK Investigational Site
South Brisbane, Queensland, Australia, 4101
Status
Study Complete
Location
GSK Investigational Site
Anaheim, California, United States, 92801
Status
Study Complete
Location
GSK Investigational Site
Greensboro, North Carolina, United States, 27403
Status
Study Complete
Location
GSK Investigational Site
Muenchen, Bayern, Germany, 80335
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
Status
Study Complete
Location
GSK Investigational Site
Recklinghausen, Nordrhein-Westfalen, Germany, 45657
Status
Study Complete
Location
GSK Investigational Site
Fairfield, Connecticut, United States, 06824
Status
Study Complete
Location
GSK Investigational Site
Porto Alegre, Rio Grande Do Sul, Brazil, 90020-090
Status
Study Complete
Location
GSK Investigational Site
Norwalk, Connecticut, United States, 06856
Status
Study Complete
Location
GSK Investigational Site
Schwetzingen, Baden-Wuerttemberg, Germany, 68723
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Boynton Beach, Florida, United States, 33437
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Manchester, Lancashire, United Kingdom, M20 4BX
Status
Study Complete
Location
GSK Investigational Site
Seattle, Washington, United States, 98104
Status
Study Complete
Location
GSK Investigational Site
Vancouver, Washington, United States, 98684
Status
Study Complete
Location
GSK Investigational Site
Witten, Nordrhein-Westfalen, Germany, 58452
Status
Study Complete
Location
GSK Investigational Site
Duisburg, Nordrhein-Westfalen, Germany, 47051
Status
Study Complete
Location
GSK Investigational Site
Bakersfield, California, United States, 93309
Status
Study Complete
Location
GSK Investigational Site
Kiel, Schleswig-Holstein, Germany, 24103
Status
Study Complete
Location
GSK Investigational Site
Sparta, New Jersey, United States, 07871
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Rochester, New York, United States, 14623
Status
Study Complete
Location
GSK Investigational Site
San Miguel de Tucumán, Argentina, T4000IAK
Status
Study Complete
Location
GSK Investigational Site
Ocala, Florida, United States, 34474
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Duncanville, Texas, United States, 75137
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46219
Status
Study Complete
Location
GSK Investigational Site
Torrington, Connecticut, United States, 06790
Status
Study Complete
Location
GSK Investigational Site
Koblenz, Rheinland-Pfalz, Germany, 56068
Status
Study Complete
Location
GSK Investigational Site
Velbert, Nordrhein-Westfalen, Germany, 42551
Status
Study Complete
Location
GSK Investigational Site
Belo Horizonte, Minas Gerais, Brazil, 30.140-001
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19107
Status
Study Complete
Location
GSK Investigational Site
Mutlangen, Baden-Wuerttemberg, Germany, 73557
Status
Study Complete
Location
GSK Investigational Site
Tuscaloosa, Alabama, United States, 35406
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Redcliffe, Queensland, Australia, 4020
Status
Study Complete
Location
GSK Investigational Site
Hooksett, New Hampshire, United States, 03106
Status
Study Complete
Location
GSK Investigational Site
São Paulo, São Paulo, Brazil, 03102-002
Status
Study Complete
Location
GSK Investigational Site
Guestrow, Mecklenburg-Vorpommern, Germany, 18273
Status
Study Complete
Location
GSK Investigational Site
Palm Springs, California, United States, 92262
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Duluth, Minnesota, United States, 55805
Status
Study Complete
Location
GSK Investigational Site
Danvers, Massachusetts, United States, 01923
Status
Study Complete
Location
GSK Investigational Site
Marietta, Georgia, United States, 30060
Status
Study Complete
Location
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45130
Status
Study Complete
Location
GSK Investigational Site
Tuebingen, Baden-Wuerttemberg, Germany, 72076
Status
Study Complete
Location
GSK Investigational Site
Singen, Baden-Wuerttemberg, Germany, 78224
Status
Study Complete
Location
GSK Investigational Site
Viña del Mar, Valparaíso, Chile, 254-0364
Status
Study Complete
Location
GSK Investigational Site
Minneapolis, Minnesota, United States, 55404
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Jonesboro, Arkansas, United States, 72401
Status
Study Complete
Location
GSK Investigational Site
Troisdorf, Nordrhein-Westfalen, Germany, 53840
Status
Study Complete
Location
GSK Investigational Site
Augusta, Georgia, United States, 30901
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Joliet, Illinois, United States, 60435
Status
Study Complete
Location
GSK Investigational Site
Mayen, Baden-Wuerttemberg, Germany, 56727
Status
Study Complete
Location
GSK Investigational Site
Frankfurt, Hessen, Germany, 60596
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Newcastle upon Tyne, United Kingdom, NE7 7DN
Status
Study Complete
Location
GSK Investigational Site
Plantation, Florida, United States, 33324
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Rheinfelden, Baden-Wuerttemberg, Germany, 79618
Status
Study Complete
Location
GSK Investigational Site
Baguio City, Benguet, Philippines, 2600
Status
Study Complete
Location
GSK Investigational Site
Dallas, Texas, United States, 75230
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bonn, Nordrhein-Westfalen, Germany, 53113
Status
Study Complete
Location
GSK Investigational Site
Blankenburg, Sachsen-Anhalt, Germany, 38889
Status
Study Complete
Location
GSK Investigational Site
Germantown, Tennessee, United States, 38138
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
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
No longer a GSK study
Actual primary completion date
2011-21-09
Actual study completion date
2013-17-07
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
Additional information
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
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