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

Phase 1
18 Years
Not Enrolling
Advanced Solid Tumor

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Trial Information

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pharmacokinetic interactions

Outcome Time Frame:

4 weeks

Safety Issue:


Principal Investigator

Ezra Cohen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago


United States: Food and Drug Administration

Study ID:




Start Date:

November 2006

Completion Date:

September 2009

Related Keywords:

  • Advanced Solid Tumor
  • metastatic
  • advanced disease
  • phase I



University of ChicagoChicago, Illinois  60637