Randomized Discontinuation Study of Lapatinib Versus Placebo in Subjects With Documented Tumor Progression After Chemotherapy, or Where no Approved Therapy Exists

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.

Timeline

Start

2007-05

Primary completion

2009-05

Completion

2009-09

Outcome

Outcome not reported

Stopped: “The study had failed to meet the primary objective of tumor response rate at 12 weeks from first dose.”

Publications

• Galsky MD, Von Hoff DD, Neubauer M, Anderson T, Fleming M, Nagarwala Y, Mahoney JM, Midwinter D, Vocila L, Zaks TZ. Target-specific, histology-independent, randomized discontinuation study of lapatinib in patients with HER2-amplified solid tumors. Invest New Drugs. 2012 Apr;30(2):695-701. doi: 10.1007/s10637-010-9541-0. Epub 2010 Sep 22.

Drugs

Indications