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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: Completed Phase 1 study, sponsored by Sanofi.

NCT01357330 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 18 participants
Start Date 2011-05
Est. Completion 2012-06
Phase Phase 1
Sanofi

713 total trials

What the finished NCT01357330 record still lists

NCT01357330 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).

The record links to 0 conditions, and to 2 interventions - of which SAR245408 (XL147) is the first listed.

NCT01357330 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT01357330's enrollment target sits among peer trials

18 1720th of 2000 higher than 216 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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Source: ClinicalTrials.gov NCT01357330, the US trial registry maintained by the National Library of Medicine. NCT01357330 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.