A PHASE I, OPEN-LABEL, DOSE-ESCALATION STUDY EVALUATING THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF GDC-0077 AS A SINGLE AGENT IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC PIK3CA-MUTANT SOLID TUMORS AND IN COMBINATION WITH ENDOCRINE AND TARGETED

Protocol: 
AAAR0323
Phase: 
I

A PHASE I, OPEN-LABEL, DOSE-ESCALATION STUDY EVALUATING THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF GDC-0077 AS A SINGLE AGENT IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC PIK3CA-MUTANT SOLID TUMORS AND IN COMBINATION WITH ENDOCRINE AND TARGETED

The purpose of the study is to evaluate the safety (side effects) and look for any anti cancer activity of GDC-0077 alone in research subjects/participants with locally advanced or metastatic PIK3CA mutant cancer or when GDC-0077 is given together with palbociclib and letrozole or with letrozole in postmenopausal women with locally advanced or metastatic PIK3CA-mutant HR?, HER2 negative (HER2?) breast cancer.

Are you Eligible? (Inclusion Criteria)

To be eligible for this study, patients must:
- be a woman who has gone through menopause
- have advanced or metastatic PIK3CA-mutant HR+/HER2- breast cancer
- have no ongoing need for treatment with corticosteroids for treatment of
cancer spread to the central nervous system

Specialty Area(s)

Trial Location

Herbert Irving Comprehensive Cancer Center
161 Fort Washington Ave.
Herbert Irving Pavilion
New York, NY 10032
United States