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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: Completed Phase 1 study, sponsored by Celcuity.
NCT02684032 is a Phase 1 study that has completed, run by Celcuity. The registered enrollment target is 141 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (135% higher). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT02684032 record still lists
NCT02684032 is an interventional study that assigns participants to a tested intervention. The registered 141 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 (135% higher).
The record links to 0 conditions, and to 4 interventions - of which Letrozole is the first listed.
NCT02684032 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02684032's enrollment target sits among peer trials
141 401st of 2000 higher than 1,599 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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