Drug Interaction Study of Sorafenib and Rapamycin in Advanced Malignancies

Advanced Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00449280
• Other study ID #: 14908B
• Status: Completed
• Phase: Phase 1
• First received: March 16, 2007
• Last updated: June 11, 2013
• Start date: November 2006
• Est. completion date: September 2009

Study information

• Verified date: June 2013
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: September 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Advanced Solid Tumor

Intervention

Drug:
• Sorafenib
400mg BID (200 mg twice daily)
• Rapamycin
30mg once weekly
• Rapamycin
3mg once daily

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic interactions		4 weeks	Yes
Secondary	Response Rate		8 weeks	No