Status:
COMPLETED
Safety Study of XL147 (SAR245408), in Combination With Paclitaxel and Carboplatin in Adults With Solid Tumors
Lead Sponsor:
Sanofi
Conditions:
Cancer
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of XL147 in combination with paclitaxel and carboplatin in adults with solid tumors. XL147 is a new chemical entity that inhibits P...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of:
- Advanced solid tumor that is no longer responding to therapies OR
- Advanced or recurrent endometrial carcinoma OR
- Advanced or recurrent ovarian carcinoma OR
- Unresectable (Stage IIIB or IV) NSCLC
- ECOG Performance Status 0-1 (ECOG status of 2 may be considered following discussion and agreement with sponsor)
- Adequate organ and bone marrow function as defined by hematological and serum chemistry limits
- At least 18 years old
- Both men and women must practice adequate contraception
- Informed consent
Exclusion
- Restriction of some therapies/medications within specific timeframes prior to enrollment and during the study including prior therapy with PI3K, AKT, or mTOR inhibitors, cytotoxic chemotherapy, biologic agents, nitrosoureas or mitomycin C, small-molecule kinase inhibitors, non-cytotoxic hormonal agents
- Known allergy or hypersensitivity to any of the components of the treatment formulations
- Taking oral corticosteroids chronically or \> 1 mg/day warfarin
- Not recovered from the toxic effects of prior therapy
- History of diabetes mellitus.
- Uncontrolled intercurrent illness
- Pregnant or breastfeeding
- Congestive heart failure, unstable angina, or a myocardial infarction within 3 months of entering the study.
- HIV positive
- Diagnosis of another malignancy may exclude subject from study
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00756847
Start Date
September 1 2008
End Date
October 1 2012
Last Update
April 10 2013
Active Locations (4)
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1
Investigational Site Number
St Louis, Missouri, United States, 63110
2
Investigational Site Number
Oklahoma City, Oklahoma, United States, 73104
3
Investigational Site Number
Houston, Texas, United States, 77030-4009
4
Investigational Site Number
Madison, Wisconsin, United States, 53792-6164