Status:
COMPLETED
Safety Study of XL765 (SAR245409) in Combination With Erlotinib 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 XL765 in combination with erlotinib (Tarceva®) in subjects with solid tumors. XL765 is a new chemical entity that inhibits the k...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of:
- Advanced solid tumor that is no longer responding to therapies OR
- Advanced or metastatic NSCLC that has previously been treated with erlotinib or gefitinib
- ECOG Performance Status 0-1
- Adequate organ and bone arrow 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, cytotoxic chemotherapy, biologic agents, nitrosoureas or mitomycin C, small-molecule kinase inhibitors, non-cytotoxic hormonal agents
- Erlotinib intolerant
- Taking oral corticosteroids chronically or \> 1 mg/day warfarin
- Not recovered from the toxic effects of prior therapy
- History of diabetes mellitus and an HgbA1c \> 7%
- 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 :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00777699
Start Date
August 1 2008
End Date
February 1 2011
Last Update
February 3 2012
Active Locations (1)
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1
Investigational Site Number 168983
Philadelphia, Pennsylvania, United States, 19111