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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 is a Phase 1 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 124 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02964507
The ClinicalTrials.gov registry entry for NCT02964507 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 124 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02964507 reports 0 study locations.
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.
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