Drug Interaction Study of Sorafenib and Rapamycin in Advanced Malignancies - Full Text View

Sponsors and Collaborators:	University of Chicago Bayer
Information provided by:	University of Chicago
ClinicalTrials.gov Identifier:	NCT00449280

Purpose

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 rapamycin and sorafenib and the antitumor activity of the combination in subjects with advanced cancers.

Condition	Intervention	Phase
Advanced Solid Tumor	Drug: Sorafenib Drug: Rapamycin	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Pharmacokinetics Study
Official Title:	A Drug Interaction Study of Sorafenib (BAY 43-9006 Tosylate) and Rapamycin in Patients With Advanced Malignancies

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Sirolimus Sorafenib Sorafenib tosylate

U.S. FDA Resources

Further study details as provided by University of Chicago:

Primary Outcome Measures:

Pharmacokinetic interactions [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Response Rate [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	November 2006
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Sorafenib two times a day every day for 28 days. Beginning on Day 15 (Week 2), rapamycin will be taken once a week until the end of the cycle (Day 28). After Day 28, weekly rapamycin and daily sorafenib will continue until disease progression or serious side effects are experienced.	Drug: Sorafenib 400mg BID (200 mg twice daily) Drug: Rapamycin 30mg once weekly
B: Experimental Sorafenib two times a day every day for 28 days. Beginning on Day 15 (Week 2), rapamycin will be taken every day until the end of the cycle (Day 28). After Day 28, rapamycin and sorafenib can continue to be taken daily until the cancer gets worse or serious side effects are experienced.	Drug: Sorafenib 400mg BID (200 mg twice daily) Drug: Rapamycin 3mg once daily
C: Experimental Rapamycin once a week starting on Day 1. Beginning on Day 15 (Week 2), sorafenib will be taken twice a day every day until the end of the cycle (Day 28). After Day 28, weekly rapamycin and daily sorafenib will continue until disease progression or serious side effects are experienced.	Drug: Sorafenib 400mg BID (200 mg twice daily) Drug: Rapamycin 30mg once weekly
D: Experimental Rapamycin every day beginning on Day 1. Starting on Day 15 (Week 2), sorafenib will be taken twice a day every day until the end of the cycle (Day 28). After Day 28, rapamycin and sorafenib can continue to be taken daily until the cancer gets worse or serious side effects are experienced.	Drug: Sorafenib 400mg BID (200 mg twice daily) Drug: Rapamycin 3mg once daily

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00449280

Locations

United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637

Sponsors and Collaborators

University of Chicago

Bayer

Investigators

Principal Investigator:

Ezra Cohen, MD

University of Chicago

More Information

No publications provided

Responsible Party:	University of Chicago ( Ezra Cohen, MD )
Study ID Numbers:	14908B
Study First Received:	March 16, 2007
Last Updated:	April 24, 2008
ClinicalTrials.gov Identifier:	NCT00449280 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Chicago:

metastatic
advanced disease
phase I

Study placed in the following topic categories:

Sirolimus
Anti-Infective Agents
Anti-Bacterial Agents
Immunologic Factors

Antifungal Agents
Protein Kinase Inhibitors
Immunosuppressive Agents
Sorafenib

Additional relevant MeSH terms:

Sirolimus
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Antibiotics, Antineoplastic

Immunosuppressive Agents
Protein Kinase Inhibitors
Pharmacologic Actions
Anti-Bacterial Agents
Therapeutic Uses
Antifungal Agents
Sorafenib

ClinicalTrials.gov processed this record on September 02, 2009