Conditions: Cancer
Keywords: Ovarian Cancer Bladder Cancer ErbB2 positive Lapatinib Gastric/Esophageal Cancer Uterine Serous Papillary Cancer
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 32
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Oral lapatinib tablets or placebo tablets
Intervention descriptions: intervention 1: Subjects administered open label lapatinib, 1500 mg to be taken orally once a day, for 12 weeks. After 12 weeks, subjects with a partial or complete response per Response Evaluation Criteria in Solid Tumors (RECIST) will continue to receive open label lapatinib (1500 mg/day orally) until disease progression. Subjects who maintain stable disease will be randomized in a 1:1 ratio to enter stage 2 of the study and receive double blind therapy of either lapatinib 1500 mg/day orally or placebo. Subjects who progress on placebo will have the option to receive lapatinib 1500 mg/day orally until further progression. Those who progress on lapatinib will be withdrawn from the study.

Protocol document: