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| Sponsor: | Sanofi-Aventis |
|---|---|
| Information provided by (Responsible Party): | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00485719 |
Purpose
The purpose of this study is to determine the safety and tolerability of XL765. XL765 is a new chemical entity that inhibits the kinases PI3K and mTOR. In preclinical studies, inactivation of PI3K has been shown to inhibit growth and induce apoptosis (programmed cell death) in tumor cells, whereas inactivation of mTOR has been shown to inhibit the growth of tumor cells.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer |
Drug: XL765 (SAR245409) |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of XL765 Administered Orally Daily to Subjects With Solid Tumors |
| Estimated Enrollment: | 75 |
| Study Start Date: | June 2007 |
| Estimated Study Completion Date: | February 2012 |
| Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Twice daily (bid) dosing
|
Drug: XL765 (SAR245409)
Gelatin capsules supplied in 5-mg, 10-mg, and 50-mg strengths administered orally
|
|
Experimental: 2
Once daily (qd) dosing
|
Drug: XL765 (SAR245409)
Gelatin capsules supplied in 5-mg, 10-mg, and 50-mg strengths administered orally
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
for subjects who are to be enrolled into the Expanded MTD Cohort and Lower-Dose Tumor Genetic Alteration Subjects:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00485719 History of Changes |
| Other Study ID Numbers: | TED11440, 2007-002437-36, XL765-001 |
| Study First Received: | June 11, 2007 |
| Last Updated: | November 15, 2011 |
| Health Authority: | United States: Food and Drug Administration; Spain: Spanish Agency of Medicines |
|
Cancer Solid Tumors |