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

TNBC

IIa

54

19

Spain, Portugal

Recruiting

PATHFINDER SITES

SPAIN

IOB - Hospital QuironSalud Barcelona

SPAIN

Hospital Universitario Ramon y Cajal

SPAIN

Arnau de Vilanova de Valencia

SPAIN

Hospital Clínico Universitario de Valencia

SPAIN

Ruber Juan Bravo/Hospital Quiron San Camilo

SPAIN

Hospital Clínico Univ. San Carlos

SPAIN

Hospital Clinico Universitario Virgen de la Victoria de Malaga

SPAIN

Hospital Universitari Arnau de Vilanova de Lleida

SPAIN

Hospital Virgen de Arrixaca

SPAIN

Hospital General de Alicante

SPAIN

Hospital Universitario San Pedro de Alcántara

SPAIN

Hospital Provincial de Castellón

SPAIN

MD Anderson Cancer Center

SPAIN

Hospital de Donostia

SPAIN

Hospital del Mar

SPAIN

Hospital Miguel Servet

PORTUGAL

Hospital Fernando Fonseca

PORTUGAL

Champalimaud Clinical Center

PORTUGAL

IPO Porto