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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 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 67 participants.
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
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2010-01 |
| Est. Completion | 2013-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01013324
The ClinicalTrials.gov registry entry for NCT01013324 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 67 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 1 intervention - of which XL147 (SAR245408) is the first listed.
NCT01013324 reports 0 study locations.
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.
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