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NCT02684032 · ClinicalTrials.gov registry record · Phase 1
A Study To Assess The Tolerability And Clinical Activity Of Gedatolisib In Combination With Palbociclib/Letrozole Or Palbociclib/Fulvestrant In Women With Metastatic Breast Cancer
A Phase 1 study, sponsored by Celcuity.
- Completed
- Registry status
- Phase 1
- Development phase
- 141
- Enrollment target
NCT02684032 is a Phase 1 study that has completed, run by Celcuity. The registered enrollment target is 141 participants.
The verdict
NCT02684032, a Phase 1 study, has completed, sponsored by Celcuity.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 141 participants
- Enrollment target
Study Summary
This is a multicenter, open label, Phase 1b study in patients with mBC. This study will have a dose escalation to identify the maximum tolerated dose (MTD) of the combination of gedatolisib plus palbociclib/fulvestrant and gedatolisib plus palbociclib/letrozole and expansion to estimate the objective response rate (OR) of the combination of gedatolisib plus palbociclib/letrozole or palbociclib/fulvestrant.
Interventions
- DRUG Letrozole
- DRUG Fulvestrant
- DRUG Palbociclib
- DRUG Gedatolisib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 141 participants |
| Start Date | 2016-06-14 |
| Est. Completion | 2022-01-19 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02684032
The ClinicalTrials.gov registry entry for NCT02684032 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 141 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Celcuity, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Letrozole is the first listed.
NCT02684032 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02684032 about?
NCT02684032 is a clinical study titled "A Study To Assess The Tolerability And Clinical Activity Of Gedatolisib In Combination With Palbociclib/Letrozole Or Palbociclib/Fulvestrant In Women With Metastatic Breast Cancer". This is a multicenter, open label, Phase 1b study in patients with mBC. This study will have a dose escalation to identify the maximum tolerated dose (MTD) of the combination of gedatolisib plus palbociclib/fulvestrant and gedatolisib plus palbociclib/letrozole and expansion to estimate the objectiv...
What is the current status of trial NCT02684032?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 141 participants. The study started on 2016-06-14. Estimated completion is 2022-01-19.
What interventions are being tested in trial NCT02684032?
The interventions under investigation include: Letrozole (DRUG), Fulvestrant (DRUG), Palbociclib (DRUG), Gedatolisib (DRUG).
Who is sponsoring clinical trial NCT02684032?
This trial is sponsored by Celcuity, which has 4 total clinical trials registered on ClinicalTrials.gov.
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