Drug Interaction Study of Sorafenib and Rapamycin in Advanced Malignancies

NCT ID: NCT00449280

Last Updated: 2013-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2009-09-30

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

Conditions

Advanced Solid Tumor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

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.

Group Type: EXPERIMENTAL

Sorafenib

Intervention Type: DRUG

400mg BID (200 mg twice daily)

Rapamycin

Intervention Type: DRUG

30mg once weekly

B

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.

Group Type: EXPERIMENTAL

Sorafenib

Intervention Type: DRUG

400mg BID (200 mg twice daily)

Rapamycin

Intervention Type: DRUG

3mg once daily

C

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.

Group Type: EXPERIMENTAL

Sorafenib

Intervention Type: DRUG

400mg BID (200 mg twice daily)

Rapamycin

Intervention Type: DRUG

30mg once weekly

D

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.

Group Type: EXPERIMENTAL

Sorafenib

Intervention Type: DRUG

400mg BID (200 mg twice daily)

Rapamycin

Intervention Type: DRUG

3mg once daily

Interventions

Sorafenib

400mg BID (200 mg twice daily)

Intervention Type: DRUG

Rapamycin

30mg once weekly

Intervention Type: DRUG

Rapamycin

3mg once daily

Intervention Type: DRUG

Other Intervention Names

Nexavar; Rapamune; Rapamune

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: collaborator

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ezra Cohen, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

University of Chicago

Chicago, Illinois, United States

Countries

United States

Other Identifiers

14908B

Identifier Type: -

Identifier Source: org_study_id