GW572016 With Docetaxel and Trastuzumab for the Treatment Of Untreated ErbB2 Over-Expressing Metastatic Breast Cancer

Phase 1 Terminated 53 enrolled Novartis Pharmaceuticals

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This study was designed to be two-part study (Phase I/Phase II). Part I was designed to find the optimal (best) doses of GW572016, docetaxel, and trastuzumab when given together. Part II was designed to evaluate the tumor response rate (shrinkage or lack of growth) in patients receiving all three drugs compared to patients receiving only docetaxel and trastuzumab.

Timeline

Start: 2005-09-26
Primary completion: 2010-06-10
Completion: 2022-06-22

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

Stopped (Business): “EGF100161 (NCT00251433) was terminated in Phase I (Phase II expansion portion of the study was never initiated) by sponsor decision.”

paper the OTR of lapatinib with 100 mg/m(2) docetaxel was not determined PMID 23878115 ↗

Publications

Results Crown J, Kennedy MJ, Tresca P, Marty M, Espie M, Burris HA, DeSilvio M, Lau MR, Kothari D, Koch KM, Dieras V. Optimally tolerated dose of lapatinib in combination with docetaxel plus trastuzumab in first-line treatment of HER2-positive metastatic breast cancer. Ann Oncol. 2013 Aug;24(8):2005-11. doi: 10.1093/annonc/mdt222.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Docetaxel	Small molecule	75 mg/m2	—
Subject	Lapatinib	Small molecule	750 mg	Oral
Subject	Lapatinib	Small molecule	1000 mg	Oral
Subject	Lapatinib	Small molecule	1250 mg	Oral
Subject	Lapatinib	Small molecule	1500 mg	Oral
Subject	Trastuzumab	Monoclonal antibody	2 mg/kg	—