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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 is a Phase 1 study that was terminated before completion, run by Gilead Sciences. The registered enrollment target is 14 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02983604
The ClinicalTrials.gov registry entry for NCT02983604 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Exemestane is the first listed.
NCT02983604 reports 0 study locations.
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.
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