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| Sponsor: | Sanofi-Aventis |
|---|---|
| Information provided by (Responsible Party): | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00486135 |
Purpose
The purpose of this study is to evaluate the safety and tolerability of XL147 in subjects with solid tumors or lymphoma. Both a capsule and a tablet formulation will be evaluated. XL147 is a new chemical entity that inhibits PI3 Kinase. Inactivation of PI3K has been shown to inhibit growth and induce apoptosis (programmed cell death) in tumor cells.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer Lymphoma |
Drug: XL147 (SAR245408) |
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 XL147 Administered Orally Daily to Subjects With Solid Tumors or Lymphoma |
| Estimated Enrollment: | 125 |
| Study Start Date: | June 2007 |
| Estimated Study Completion Date: | April 2012 |
| Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Daily dosing for 21 days/7 days off
|
Drug: XL147 (SAR245408)
Gelatin capsules supplied in 25-mg and 100-mg dosage strengths
|
|
Experimental: 2
Continuous daily dosing
|
Drug: XL147 (SAR245408)
Gelatin capsules supplied in 25-mg and 100-mg dosage strengths
|
|
Experimental: 3
Continuous daily dosing
|
Drug: XL147 (SAR245408)
Tablets supplied as 100-mg, 150-mg, and 200-mg dosage strengths
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
For the subjects with solid tumors who are to be enrolled into the expanded MTD cohort and tumor genetic alteration subjects:
Exclusion Criteria:
Contacts and Locations| United States, Massachusetts | |
| Investigational Site Number 1503 | |
| Boston, Massachusetts, United States, 02115 | |
| Study Director: | Clinical Sciences & Operations | Sanofi-Aventis |
More Information
| Responsible Party: | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00486135 History of Changes |
| Other Study ID Numbers: | TED11433, XL147-001 |
| Study First Received: | June 11, 2007 |
| Last Updated: | November 7, 2011 |
| Health Authority: | United States: Food and Drug Administration; Spain: Spanish Agency of Medicines |
|
Cancer Solid tumors Lymphoma |
|
Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |