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NCT01013324 · ClinicalTrials.gov registry record · Phase 2

Study of XL147 (SAR245408) in Advanced or Recurrent Endometrial Carcinoma

A Phase 2 study, sponsored by Sanofi.

Completed
Registry status
Phase 2
Development phase
67
Enrollment target

NCT01013324: Completed Phase 2 study, sponsored by Sanofi.

NCT01013324 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 67 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01013324, a Phase 2 study, has completed, sponsored by Sanofi.

COMPLETED
Registry status
Phase 2
Development phase
67 participants
Enrollment target

Study Summary

There has not been any systemic therapy approved in the United States or in Europe for treating advanced or recurrent endometrial cancer (EC). This study will evaluate the safety and preliminary efficacy of XL147 in advanced or recurrent EC. Constitutively active phosphatidylinositol-3 kinase (PI3K)/phosphatase and tensin homolog on chromosome 10 (PTEN) pathway signaling is common in EC and involved in the development and/or progression of the disease. PTEN deficiency and/or activating mutations/amplification in the PIK3CA gene that encodes the p110α catalytic subunit of PI3K have been frequently detected in EC patients. XL147 is a potent and highly selective inhibitor of the Class I PI3K family of lipid kinases. In addition, in vivo preclinical data have demonstrated that XL147 targets both proximal and distal signaling in the PI3K/PTEN pathway. Therefore, XL147 may have utility in the treatment of subjects with advanced or recurrent EC.

Interventions

  • DRUG XL147 (SAR245408)

Trial Details

FieldValue
Enrollment Target 67 participants
Start Date 2010-01
Est. Completion 2013-03
Phase Phase 2
Sanofi

713 total trials

What the finished NCT01013324 record still lists

NCT01013324 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower).

The record links to 0 conditions, and to 1 intervention - of which XL147 (SAR245408) is the first listed.

NCT01013324 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01013324 about?

NCT01013324 is a clinical study titled "Study of XL147 (SAR245408) in Advanced or Recurrent Endometrial Carcinoma". There has not been any systemic therapy approved in the United States or in Europe for treating advanced or recurrent endometrial cancer (EC). This study will evaluate the safety and preliminary efficacy of XL147 in advanced or recurrent EC. Constitutively active phosphatidylinositol-3 kinase (PI3K...

What is the current status of trial NCT01013324?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 67 participants. The study started on 2010-01. Estimated completion is 2013-03.

What interventions are being tested in trial NCT01013324?

The interventions under investigation include: XL147 (SAR245408) (DRUG).

Who is sponsoring clinical trial NCT01013324?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01013324's enrollment target sits among peer trials

67 974th of 2000 higher than 1,026 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT01013324, the US trial registry maintained by the National Library of Medicine. NCT01013324 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.