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NCT01673737 · ClinicalTrials.gov registry record · Phase 1
A Phase I/Ib Trial for the Evaluation of SAR260301 in Monotherapy or in Combination With Vemurafenib in Patients With Various Advanced Cancer
A Phase 1 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 1
- Development phase
- 75
- Enrollment target
NCT01673737 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 75 participants.
The verdict
NCT01673737, a Phase 1 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 75 participants
- Enrollment target
Study Summary
Primary Objective: Part A - Monotherapy: \- To determine the maximum tolerated dose (MTD) of SAR260301 administered as monotherapy and either on a once or twice daily schedule, to patients with advanced solid tumors or lymphomas. Part B - Combination: \- To determine the maximum tolerated dose (MTD) of SAR260301 administered in combination with the recommended standard dosage of vemurafenib to patients with unresectable / metastatic v-raf murine sarcoma viral oncogene homolog B1 (BRAF)-mutated melanoma. Secondary Objectives: * To characterize the overall safety and tolerability profile of SAR260301 administered as monotherapy (Part A) and in combination with vemurafenib (Part B). * To characterize the pharmacokinetic (PK) profile of SAR260301 administered as monotherapy (Part A) and in combination with vemurafenib (Part B) as well as vemurafenib PK in combination with SAR260301 (Part B) * To evaluate food effect on SAR260301 PK (Part A) * To assess preliminary antitumor activity according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1 criteria). * To assess preliminary antitumor activity using volumetric computed tomography (CT) or magnetic resonance imaging(MRI) * To evaluate the pharmacodynamic (PD) effects of SAR260301 on blood and tumor. * To evaluate PK/PD relationships. * To identify the recommended phase 2 dose of SAR260301 in combination with vemurafenib (RP2D) (Part B only) * To assess potential induction effect of SAR260301 on cytochrome P450 (CYP) isoenzyme 3A (CYP3A) (Part A)
Interventions
- DRUG Vemurafenib
- DRUG SAR260301
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2012-08 |
| Est. Completion | 2015-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01673737
The ClinicalTrials.gov registry entry for NCT01673737 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 75 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 2 interventions - of which Vemurafenib is the first listed.
NCT01673737 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01673737 about?
NCT01673737 is a clinical study titled "A Phase I/Ib Trial for the Evaluation of SAR260301 in Monotherapy or in Combination With Vemurafenib in Patients With Various Advanced Cancer". Primary Objective: Part A - Monotherapy: \- To determine the maximum tolerated dose (MTD) of SAR260301 administered as monotherapy and either on a once or twice daily schedule, to patients with advanced solid tumors or lymphomas. Part B - Combination: \- To determine the maximum tolerated dose (...
What is the current status of trial NCT01673737?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 75 participants. The study started on 2012-08. Estimated completion is 2015-02.
What interventions are being tested in trial NCT01673737?
The interventions under investigation include: Vemurafenib (DRUG), SAR260301 (DRUG).
Who is sponsoring clinical trial NCT01673737?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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