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NCT02983604 · ClinicalTrials.gov registry record · Phase 1
GS-5829 in Combination With Fulvestrant or Exemestane in Women With Advanced Estrogen Receptor Positive, HER2 Negative-Breast Cancer
A Phase 1 study, sponsored by Gilead Sciences.
- Terminated
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT02983604: Clinical Trial Phase 1 study, sponsored by Gilead Sciences.
NCT02983604 is a Phase 1 study that was terminated before completion, run by Gilead Sciences. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02983604, a Phase 1 study, was terminated before completion, sponsored by Gilead Sciences.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study 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.
Primary Outcome
A DLT was a toxicity as defined below: * Grade ≥ 4 neutropenia * Grade ≥ 3 neutropenia with fever * Grade ≥ 3 thrombocytopenia * Grade ≥ 2 bleeding (e.g., gastrointestinal, respiratory, epistaxis, purpura) * Grade ≥ 3 or higher non-hematologic toxicity, except: * Grade 3 nausea or emesis with maximum duration of 48 hours on adequate medical therapy * Grade 3 diarrhea which persists for \< 72 hours in the absence of adequate medical therapy * Grade ≥ 2 non-hematologic treatment-emergent adv
Interventions
- DRUG Exemestane
- DRUG Fulvestrant
- DRUG GS-5829
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2017-01-10 |
| Est. Completion | 2018-07-19 |
| Phase | Phase 1 |
Why NCT02983604 stopped before completion
NCT02983604 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 3 interventions - of which Exemestane is the first listed.
NCT02983604 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02983604 about?
NCT02983604 is a clinical study titled "GS-5829 in Combination With Fulvestrant or Exemestane in Women With Advanced Estrogen Receptor Positive, HER2 Negative-Breast Cancer". 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 fulvestr...
What is the current status of trial NCT02983604?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2017-01-10. Estimated completion is 2018-07-19.
What interventions are being tested in trial NCT02983604?
The interventions under investigation include: Exemestane (DRUG), Fulvestrant (DRUG), GS-5829 (DRUG).
Who is sponsoring clinical trial NCT02983604?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02983604's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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