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NCT02964507 · ClinicalTrials.gov registry record · Phase 1
Dose Escalation and Expansion Study of GSK525762 in Combination With Fulvestrant in Participants With Hormone Receptor-positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Advanced or Metastatic Breast Cancer
A Phase 1 study, sponsored by GlaxoSmithKline.
- Terminated
- Registry status
- Phase 1
- Development phase
- 124
- Enrollment target
NCT02964507: Clinical Trial Phase 1 study, sponsored by GlaxoSmithKline.
NCT02964507 is a Phase 1 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 124 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (107% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02964507, a Phase 1 study, was terminated before completion, sponsored by GlaxoSmithKline.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 124 participants
- Enrollment target
Study Summary
This is a combination Phase I and Phase II study, with an aim to evaluate the combination of GSK525762 and fulvestrant in women with HR+/HER2- advanced or metastatic breast cancer, who have disease that has progressed after prior treatment with at least one line of endocrine therapy. The objectives of the study are to first identify, in open-label single-arm Phase I, a recommended Phase II dose of GSK525762 that may be combined safely with fulvestrant. Phase I will follow a modified toxicity probability interval (mTPI) design, and a sentinel group will be evaluated first for dose-limiting toxicity and further expanded to collect additional safety data. This will be followed by a double-blind, randomized controlled Phase II, to identify the clinical activity of the two study treatments when given in combination. The composition of Phase II will be selected at the end of Phase I.
Primary Outcome
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, any other situation su
Interventions
- DRUG Placebo
- DRUG Fulvestrant
- DRUG GSK525762
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 124 participants |
| Start Date | 2019-09-26 |
| Est. Completion | 2021-07-19 |
| Phase | Phase 1 |
Why NCT02964507 stopped before completion
NCT02964507 is an interventional study that assigns participants to a tested intervention. The registered 124 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (107% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02964507 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02964507 about?
NCT02964507 is a clinical study titled "Dose Escalation and Expansion Study of GSK525762 in Combination With Fulvestrant in Participants With Hormone Receptor-positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Advanced or Metastatic Breast Cancer". This is a combination Phase I and Phase II study, with an aim to evaluate the combination of GSK525762 and fulvestrant in women with HR+/HER2- advanced or metastatic breast cancer, who have disease that has progressed after prior treatment with at least one line of endocrine therapy. The objectives ...
What is the current status of trial NCT02964507?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 124 participants. The study started on 2019-09-26. Estimated completion is 2021-07-19.
What interventions are being tested in trial NCT02964507?
The interventions under investigation include: Placebo (DRUG), Fulvestrant (DRUG), GSK525762 (DRUG).
Who is sponsoring clinical trial NCT02964507?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02964507's enrollment target sits among peer trials
124 471st of 2000 higher than 1,526 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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