Trials / Terminated
TerminatedNCT02983604
GS-5829 in Combination With Fulvestrant or Exemestane in Women With Advanced Estrogen Receptor Positive, HER2 Negative-Breast Cancer
A Phase 1b/2 Study of GS-5829 in Combination With Fulvestrant or Exemestane in Subjects With Advanced Estrogen Receptor Positive, HER2 Negative-Breast Cancer
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 14 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GS-5829 | Tablet(s) administered orally once daily |
| DRUG | Exemestane | 25 mg tablet administered orally once daily (or in accordance with locally approved labeling) |
| DRUG | Fulvestrant | Administered every 28 days (± 3 days) intramuscularly in accordance with locally approved labeling Participants initiating fulvestrant on Cycle 1 Day 1 and have not received any prior dose of fulvestrant will receive a single additional dose of fulvestrant on Cycle 1 Day 15. |
Timeline
- Start date
- 2017-01-10
- Primary completion
- 2018-07-19
- Completion
- 2018-07-19
- First posted
- 2016-12-06
- Last updated
- 2019-08-07
- Results posted
- 2019-08-07
Locations
6 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02983604. Inclusion in this directory is not an endorsement.