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NCT01357330 · ClinicalTrials.gov registry record · Phase 1
Oral SAR245408 (XL147) and Oral MSC1936369B in Patients With Locally Advanced or Metastatic Solid Tumors
A Phase 1 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT01357330 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 18 participants.
The verdict
NCT01357330, a Phase 1 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
Primary Objective: \- To determine the maximum tolerated dose(s) (MTD) and the recommended Phase 2 dose(s) (RP2D) of SAR245408 and MSC1936369B when combined in adult subjects with locally advanced or metastatic solid tumors. Secondary Objective: * To characterize the safety and tolerability of SAR245408 and MSC1936369B combination therapy administered orally to adult patients with locally advanced or metastatic solid tumors * To evaluate the pharmacokinetic (PK) profile of SAR245408 and MSC1936369B when used in combination * To evaluate the pharmacodynamic (PD) effect of the SAR245408/MSC1936369B combination by assessing target and pathway inhibition
Interventions
- DRUG SAR245408 (XL147)
- DRUG MSC1936369B
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2011-05 |
| Est. Completion | 2012-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01357330
The ClinicalTrials.gov registry entry for NCT01357330 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 18 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 SAR245408 (XL147) is the first listed.
NCT01357330 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01357330 about?
NCT01357330 is a clinical study titled "Oral SAR245408 (XL147) and Oral MSC1936369B in Patients With Locally Advanced or Metastatic Solid Tumors". Primary Objective: \- To determine the maximum tolerated dose(s) (MTD) and the recommended Phase 2 dose(s) (RP2D) of SAR245408 and MSC1936369B when combined in adult subjects with locally advanced or metastatic solid tumors. Secondary Objective: * To characterize the safety and tolerability of SA...
What is the current status of trial NCT01357330?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2011-05. Estimated completion is 2012-06.
What interventions are being tested in trial NCT01357330?
The interventions under investigation include: SAR245408 (XL147) (DRUG), MSC1936369B (DRUG).
Who is sponsoring clinical trial NCT01357330?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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