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| Sponsor: | Sanofi-Aventis |
|---|---|
| Information provided by (Responsible Party): | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT01013324 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Endometrial Cancer Endometrial Neoplasms |
Drug: XL147 (SAR245408) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 2 Study of XL147 (SAR245408) in Subjects With Advanced or Recurrent Endometrial Cancer |
| Estimated Enrollment: | 88 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Single Arm
All subjects will receive single-agent XL147 dosed daily
|
Drug: XL147 (SAR245408)
dosed as capsules taken orally daily
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: For site information, send an email with site number to | Contact-Us@sanofi-aventis.com |
| United States, Pennsylvania | |
| Investigational Site Number 1132 | Recruiting |
| Abington, Pennsylvania, United States, 19001 | |
| Study Director: | Clinical Sciences & Operations | Sanofi-Aventis |
More Information
| Responsible Party: | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT01013324 History of Changes |
| Other Study ID Numbers: | ARD11436, XL147-201 |
| Study First Received: | November 10, 2009 |
| Last Updated: | September 12, 2011 |
| Health Authority: | United States: Food and Drug Administration; Belgium: Federal Agency for Medicinal Products and Health Products; France: Afssaps - French Health Products Safety Agency |
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endometrial cancer endometrial carcinoma carcinoma of the endometrium cancer of the endometrium |
|
Neoplasms Endometrial Neoplasms Sarcoma, Endometrial Stromal Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site |
Uterine Diseases Genital Diseases, Female Neoplasms, Complex and Mixed Neoplasms by Histologic Type Sarcoma Neoplasms, Connective and Soft Tissue Endometrial Stromal Tumors |