PATHFINDER
OFFICIAL TITLE: A MULTICENTER, OPEN-LABEL, NON-COMPARATIVE, THREE-ARM, PHASE IIa TRIAL OF IPATASERTIB (GDC-0068) IN COMBINATION WITH NON-TAXANE CHEMOTHERAPY AGENTS FOR TAXANE-PRETREATED UNRESECTABLE LOCALLY ADVANCED OR METASTATIC TRIPLE-NEGATIVE BREAST CANCER PATIENTS (PATHFINDER)
PROJECT DETAILS
THIS IS A PROSPECTIVE, OPEN-LABEL, NON-COMPARATIVE 3-ARM CLINICAL TRIAL. THE STUDY WILL BE DIVIDED INTO TWO STAGES: A SAFETY RUN-IN PART FOLLOWED BY A NON-RANDOMIZED PHASE IIA STAGE AS AN EXPANSION STUDY.
PRIMARY GOAL WANTS TO EVALUATE THE SAFETY AND TOLERABILITY OF IPATASERTIB (GDC-0068) IN COMBINATION WITH CAPECITABINE, ERIBULIN, OR CARBOPLATIN PLUS GEMCITABINE IN THE INTENTION-TO-TREAT (ITT) POPULATION OF PATIENTS WITH TAXANE-PRETREATED UNRESECTABLE LOCALLY ADVANCED OR METASTATIC TRIPLE-NEGATIVE BREAST CANCER (TNBC).
THE SECONDARY GOAL WANTS TO DETERMINE THE EFFICACY OF IPATASERTIB (GDC-0068) IN COMBINATION WITH CAPECITABINE, ERIBULIN, OR CARBOPLATIN PLUS GEMCITABINE IN THE ITT POPULATION AND IN EACH TREATMENT ARM.
PATHFINDER AT CLINICALTRIALS.GOV
TUMOR TYPE
PHASE
N
SITES
COUNTRY
STATUS
Recruiting
PATHFINDER SITES
