Status:
COMPLETED
Drug Interaction Study of Sorafenib and Rapamycin in Advanced Malignancies
Lead Sponsor:
University of Chicago
Collaborating Sponsors:
Bayer
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The goal of this study is to determine whether a significant pharmacokinetic interaction exists between rapamycin and sorafenib. This study will also look at the toxicity of the combination of rapamy...
Eligibility Criteria
Inclusion
- Solid cancer for which curative measures have failed or for which there is no known superior treatment
- ECOG performance status 0-2
- Measurable or non-measurable disease
- Life expectancy of greater than 12 weeks and no anticipated need for other antineoplastic therapy in the next 4 weeks
- Age 18 years or older
- Patients must have adequate organ and marrow function as defined below:
- ALT and AST less than or equal to 2.5 x the ULN (\< 5 x ULN for patients with liver involvement).
- hemoglobin greater than or equal to 9 g/dL
- absolute neutrophil count greater than or equal to 1,500/μL
- platelets greater than or equal to 100,000/μL (greater than or equal to 35,000/μL without transfusion for patients with CLL/SLL or follicular lymphoma)
- total bilirubin less than or equal to 1.5 x ULN
- creatinine less than or equal to 1.5 x ULN
- Women of childbearing potential must have a negative pregnancy test within 7 days of the start of treatment.
- Ability to understand and the willingness to sign a written informed consent document
- Must not have any evidence of bleeding diathesis.
Exclusion
- Patients who have had chemotherapy or immunotherapy within 3 weeks or radiotherapy within 14 days prior to entering the study
- Patients may not be receiving any other investigational agents or any concomitant antineoplastic therapy
- Patients with uncontrolled brain metastases.
- Concurrent illness or medication exclusions
- HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with sorafenib or rapamycin.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00449280
Start Date
November 1 2006
End Date
September 1 2009
Last Update
June 12 2013
Active Locations (1)
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1
University of Chicago
Chicago, Illinois, United States, 60637