Last updated: 11/07/2018 17:31:19
Randomized Discontinuation Study of Lapatinib Versus Placebo in Subjects with Documented Tumor Progression After Chemotherapy, or Where no Approved Therapy Exists
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Trial overview
Official title: A Phase II, Placebo Controlled, Double-Blind, Randomized, Discontinuation Study of Lapatinib Administered Orally to Subjects with ErbB2 Positive Ovarian, Gastric/Esophageal Adenocarcinoma, Uterine Serous Papillary, or Bladder Cancer
Trial description: This study will examine the efficacy and safety of lapatinib in patients with ErbB2 positive ovarian, gastric/esophageal adenocarcinoma, uterine serous papillary, or bladder cancers.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Number of participants with the indicated tumor response at 12 weeks from first dose
Timeframe: Week 12
Percentage of participants who remained progression-free 12 weeks after randomization
Timeframe: Week 12 after randomization.
Secondary outcomes:
Duration of response
Timeframe: (assessments every 12 weeks until death for withdrawn participants and every 3 weeks for participants continuing on lapatinib)
Progression-free survival (PFS)
Timeframe: From start of treatment to disease progression/death (assessments every 12 weeks until death for withdrawn participants and every 3 weeks for participants continuing on lapatinib)
Time to disease progression (TTP)
Timeframe: From start of treatment to disease progression/death (up to 83.3 weeks)
Number of participants with the indicated change in cancer antigen-125 (CA-125) levels from Day 1
Timeframe: Pre-dose and every 6 weeks until withdrawal (up to 84.1 weeks)
Incidence of MET amplification in gastric cancer
Timeframe: Performed on archived tissue collected at screening.
Incidence of ErbB2-positive participants
Timeframe: Screening
Interventions:
Enrollment:
32
Primary completion date:
2009-28-05
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Galsky MD, VonHoff DD, Neubauer M, Anderson T, Fleming M, Sweetman RW, Mahoney JM, Midwinter D, Vocila L, Zaks TZ. PCX Tracking: Target-Specific, Histology-Independent, Randomized Discontinuation Study of Lapatinib in Patients with HER2-Amplified Solid Tumors (LPT108741). [Invest New Drugs]. 2012;30:695-701.
Medical condition
Cancer
Product
lapatinib
Collaborators
Not applicable
Study date(s)
May 2007 to May 2009
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Signed written informed consent.
- Age >= 18 years old.
- Have New York Heart Association Class III or IV, cardiac disease, myocardial infarction within past 6 months, unstable arrhythmia or evidence of ischemia on electrocardiogram.
- Subjects who have had chemotherapy or radiotherapy within 3 weeks prior to entering the study or who have unresolved or unstable, serious toxicity from prior administration of another investigational drug and/or of prior cancer treatment.
Inclusion and exclusion criteria
Inclusion criteria:
- Signed written informed consent.
- Age >= 18 years old.
- Life expectancy of at least 12 weeks.
- Have histologically confirmed ovarian, gastric/esophageal adenocarcinoma, uterine serous papillary, or bladder cancer.
- Have ErbB2-positive cancer as determined by Fluorescence In Situ Hybridization (FISH) assay.
- Have documented tumor progression after receiving all standard/approved chemotherapies per National Comprehensive Cancer Network (NCCN) guidelines (V1) for their specific cancer and no approved therapy exists.
- Have one or more tumors measurable by medical imaging and assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Have archived tumor tissue available for biomarker analysis.
- Have a negative serum pregnancy test if female of childbearing potential.
- Any chemotherapy, major surgery, or irradiation must have been completed at least 3 weeks prior to receiving study drug (6 weeks for mitomycin-C or nitrosourea) and subject must have recovered from all toxicities incurred as a result of previous therapy.
- Have a gastrointestinal tract intact enough to swallow and assure absorption of the drug.
- Women of childbearing potential must have a negative serum pregnancy test at screening and must use an approved contraceptive method, if appropriate (for example, intrauterine device, birth control pills, or barrier device) beginning 2 weeks before the first dose of investigational product and for 28 days after the final dose of investigational product. Males able to father a child must practice adequate methods of birth control or practice complete abstinence from intercourse from the first dose of investigational treatment until one week after the final dose of investigational treatment.
- Have a cardiac ejection fraction within institutional range of normal as measured by either echocardiogram or multigated acquisition scans. The same method of cardiac evaluation must be used consistently throughout the study.
- Subjects must have adequate organ function: Hematologic: absolute neutrophil count >1.5 x 109/L hemoglobin >9 g/dL platelets >75 x 109/L Hepatic: albumin >2.5 g/dL serum bilirubin <1.25 x upper limit of normal aspartate aminotransferase/alanine aminotransferase <3 x ULN if no documented liver metastases aspartate aminotransferase/alanine aminotransferase <5 x ULN with documented liver metastases Renal: serum creatinine <2.0 mg/dL
- OR
- calculated creatinine clearance1 >40 mL/min
Exclusion criteria:
- Have New York Heart Association Class III or IV, cardiac disease, myocardial infarction within past 6 months, unstable arrhythmia or evidence of ischemia on electrocardiogram.
- Subjects who have had chemotherapy or radiotherapy within 3 weeks prior to entering the study or who have unresolved or unstable, serious toxicity from prior administration of another investigational drug and/or of prior cancer treatment.
- Concurrent treatment with an investigational agent or participation in another treatment clinical trial.
- Prior lapatinib therapy.
- ECOG Performance Status 2 or greater.
- Subjects receiving concurrent chemotherapy, radiation therapy, immunotherapy, biologic therapy (including an ErbB1 and/or ErbB2 inhibitor), or hormonal therapy for treatment of their cancer. Concurrent treatment with bisphosphonates is allowed.
- History of allergic reactions attributed to compounds of similar chemical composition (quinazolines) to lapatinib.
- Concurrent treatment with prohibited medications.
- Malabsorption syndrome, resection of the small bowel or active, uncontrolled ulcerative colitis.
- Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical or psychiatric disorder that would interfere with the subject's safety.
- Uncontrolled infection.
- Pregnant or lactating females.
Trial location(s)
Location
GSK Investigational Site
Denver, Colorado, United States, 80218
Status
Study Complete
Location
GSK Investigational Site
Fort Worth, Texas, United States, 76104
Status
Study Complete
Location
GSK Investigational Site
Minneapolis, Minnesota, United States, 55404
Status
Study Complete
Location
GSK Investigational Site
Leesburg, Virginia, United States, 20176
Status
Study Complete
Location
GSK Investigational Site
Greenville, South Carolina, United States, 29605
Status
Study Complete
Showing 1 - 6 of 20 Results
Study documents
Clinical study report
Available language(s): English
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
2009-28-05
Actual study completion date
2009-28-05
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
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