A Drug Interaction Study of Sorafenib (BAY 43-9006 Tosylate) and Rapamycin in Patients With Advanced Malignancies
Inclusion Criteria:
- 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 Criteria:
- 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.