Overview

Study of Trastuzumab-emtansine in Patients With HER2-positive Metastatic Colorectal Cancer Progressing After Trastuzumab and Lapatinib.

Status:
Unknown status

Trial end date:
2019-06-01

Target enrollment:

Participant gender:

Summary

This is a phase II, open label, multicenter study. Patients with advanced colon rectal cancer (CRC) harboring an amplified HER2 that have been previously treated and progressed with an aNti-HER2 treatment, will be treated with the anti HER2 antibody conjugate trastuzumab emtansine (TDM1). Patients will receive study medication until disease progression, unacceptable toxicity, withdrawal of consent or death. Main objective of the study is the evaluation of objective response rate according to RECIST 1.1 criteria. Disease control rate, defined as the sum of complete, partial and stable disease patients over total patient, followed by response duration, time to progression and safety are secondary endpoints.

Phase:

Phase 2

Details

Lead Sponsor:

Fondazione del Piemonte per l'Oncologia

Treatments:

Ado-Trastuzumab Emtansine
Lapatinib
Maytansine
Trastuzumab