AZD8931, an EGFR inhibitor, in combination with FOLFIRI: A Phase I/II study to determine the importance of schedule and activity in colorectal cancer
Description
Design:
PANTHER is a phase I/II trial in patients with recurrent or metastatic colorectal cancer. Phase I has closed to recruitment. The phase II part of the study is a single arm trial of AZD8931 + FOLFIRI.
Treatment:
Patients will receive AZD8931 (an EGFR/ERBB inhibitor) in combination with FOLinic acid, Fluorouracil and IRInotecan (FOLFIRI). Patients may remain on treatment until disease progression or until a reason other than progressive disease warrants the discontinuation of all trial treatment.
Key inclusion/exclusion criteria:
Patients must have Histopathological/cytological diagnosis of non-resectable, recurrent or metastatic colorectal cancer. Tumour must be wild type RAS, and they must have measureable disease by RECIST criteria v1.1. Life expectancy of patients must be >3 months. Patients may not have had chemotherapy for metastatic disease or prior treatment with agents targeting the ERBB pathway, or had previous treatment with anthracyclines or mitoxantrone.
Duration of recruitment:
Recruitment is now closed.
Aim
The primary objective for phase II is to evaluate the efficacy of AZD8931 plus FOLFIRI in terms of best overall response rate, defined using RECIST v1.1 criteria.