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NCT03284957 · ClinicalTrials.gov registry record · Phase 1
Phase 1/2 Study of Amcenestrant (SAR439859) Single Agent and in Combination With Other Anti-cancer Therapies in Postmenopausal Women With Estrogen Receptor Positive Advanced Breast Cancer
A Phase 1 study, sponsored by Sanofi.
- Terminated
- Registry status
- Phase 1
- Development phase
- 136
- Enrollment target
NCT03284957 is a Phase 1 study that was terminated before completion, run by Sanofi. The registered enrollment target is 136 participants.
The verdict
NCT03284957, a Phase 1 study, was terminated before completion, sponsored by Sanofi.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 136 participants
- Enrollment target
Study Summary
Primary Objectives: Dose Escalation: * To assess the incidence rate of dose-limiting toxicity (DLT) and to determine the maximum tolerated dose (MTD) as well as the recommended dose (RD) of amcenestrant administered as monotherapy and in combination with palbociclib * To assess the incidence rate of DLT and determine the RD of everolimus or abemaciclib in combination with the selected amcenestrant dose for the combination therapy Safety Run-In: \- To confirm the RD of amcenestrant in combination with alpelisib Dose Expansion: * Antitumor activity using objective response rate (ORR) * Overall safety profile of amcenestrant administered in combination with palbociclib, alpelisib, everolimus, and abemaciclib Secondary Objectives: * Overall safety profile of amcenestrant monotherapy and in combination * Pharmacokinetic (PK) profile of amcenestrant administered as monotherapy or in combination and PK profile of palbociclib, alpelisib, everolimus and abemaciclib * Antitumor activity using ORR, the clinical benefit rate (CBR) and progression free survival (PFS) * Time to first tumor response * Residual ER availability with positron emission tomography (PET) scan \[(18)F\] fluoroestradiol (18F-FES) uptake with increasing doses of amcenestrant * Food effect on PK of amcenestrant * Potential induction/inhibition effect of amcenestrant on cytochrome P450 (CYP) 3A using 4b-OH cholesterol
Interventions
- DRUG Everolimus
- DRUG Palbociclib
- DRUG Abemaciclib
- DRUG Alpelisib
- DRUG Amcenestrant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 136 participants |
| Start Date | 2017-09-20 |
| Est. Completion | 2024-11-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03284957
The ClinicalTrials.gov registry entry for NCT03284957 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 136 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Everolimus is the first listed.
NCT03284957 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03284957 about?
NCT03284957 is a clinical study titled "Phase 1/2 Study of Amcenestrant (SAR439859) Single Agent and in Combination With Other Anti-cancer Therapies in Postmenopausal Women With Estrogen Receptor Positive Advanced Breast Cancer". Primary Objectives: Dose Escalation: * To assess the incidence rate of dose-limiting toxicity (DLT) and to determine the maximum tolerated dose (MTD) as well as the recommended dose (RD) of amcenestrant administered as monotherapy and in combination with palbociclib * To assess the incidence rate ...
What is the current status of trial NCT03284957?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 136 participants. The study started on 2017-09-20. Estimated completion is 2024-11-08.
What interventions are being tested in trial NCT03284957?
The interventions under investigation include: Everolimus (DRUG), Palbociclib (DRUG), Abemaciclib (DRUG), Alpelisib (DRUG), Amcenestrant (DRUG).
Who is sponsoring clinical trial NCT03284957?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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