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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

Phase 2
18 Years
Not Enrolling

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Trial Information

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

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)

- 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

- Have a gastrointestinal tract intact enough to swallow and assure absorption of the

- 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

- 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:


absolute neutrophil count >1.5 x 109/L hemoglobin >9 g/dL platelets >75 x 109/L


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


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

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Number of Participants With the Indicated Tumor Response at 12 Weeks From First Dose

Outcome Description:

Per Response Evaluation Criteria In Solid Tumors (RECIST): Complete response (CR), disappearance of all lesions; partial response (PR), >=30% decrease in the measurements of the largest lesions; stable disease (SD), insufficient shrinkage to qualify for PR or insufficient increase to qualify for progressive disease (PD); PD, >=20% increase in measurements of lesions or appearance of new lesions. Data were not fully analyzed due to early study termination.

Outcome Time Frame:

Week 12

Safety Issue:


Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

May 2007

Completion Date:

September 2009

Related Keywords:

  • Cancer
  • Ovarian Cancer
  • Bladder Cancer
  • ErbB2 positive
  • Lapatinib
  • Gastric/Esophageal Cancer
  • Uterine Serous Papillary Cancer



GSK Investigational SiteIndianapolis, Indiana  46260
GSK Investigational SiteDuluth, Minnesota  55805
GSK Investigational SiteSt. Louis, Missouri  63141
GSK Investigational SiteRaleigh, North Carolina  27609
GSK Investigational SiteFort Worth, Texas  76104
GSK Investigational SiteColumbia, South Carolina  29210
GSK Investigational SiteSalem, Virginia  24153
GSK Investigational SiteNew York, New York  10021
GSK Investigational SiteAurora, Colorado  80012
GSK Investigational SiteKansas City, Kansas  66160
GSK Investigational SiteHenderson, Nevada  89014
GSK Investigational SiteSeattle, Washington  98133