drugset / Trial / NCT02983604
GS-5829 in Combination With Fulvestrant or Exemestane in Women With Advanced Estrogen Receptor Positive, HER2 Negative-Breast Cancer
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The primary objectives of the Phase 1b Dose Escalation part of this study are to characterize the safety and tolerability of GS-5829 in combination with exemestane or fulvestrant and to determine the maximum tolerated dose (MTD) or the recommended Phase 2 dose of GS-5829 in combination with fulvestrant in women with advanced estrogen receptor positive, HER2-negative (ER+/HER2-) breast cancer. The primary objective of the Randomized Phase 2 Dose Expansion portion of this study is to evaluate the efficacy of GS-5829 in combination with fulvestrant compared to fulvestrant alone in women with advanced ER+/HER2- breast cancer. This study was terminated early and the Phase 2 portion of the study was not conducted.
Timeline
- Start
- 2017-01-10
- Primary completion
- 2018-07-19
- Completion
- 2018-07-19
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alobresib | Small molecule | — | Oral |
| Background | Exemestane | Small molecule | 25 mg | Oral |
| Background | Fulvestrant | Small molecule | — | Intramuscular |