Solid Tumors Using Ixabepilone and Dasatinib

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients are being asked to take part in this study because they have been diagnosed with an advanced solid tumor that is not responding to standard treatments. This study will find the highest dose of ixabepilone and dasatinib in combination that can be given without causing severe side effects.

Both ixabepilone and dasatinib have individually been tested in many (several thousand) patients, however the combination of the two drugs has not yet been tested in humans.

All patients who will take part in this study will receive combined drug therapy of dasatinib and ixabepilone. Dasatinib is a pill that is taken by mouth. Ixabepilone is a medicine that will be given by vein (IV).

All participants will receive ixabepilone by vein once every three weeks as well as dasatinib by mouth once daily.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medstar Health Research Institute; Washington Hospital Center
• Collaborator: Bristol-Myers Squibb
• Treatments: Dasatinib; Epothilones

Criteria

Inclusion Criteria:

• Have a solid tumor malignancy that is metastatic or locally advanced/unresectable

• Progression through standard therapy

• Histological documentation of cancer

• Must be off prior chemotherapy or radiation therapy for at least 3 weeks

• Must have adequate organ and marrow function prior to the start of study treatment as defined by the protocol

• Must be able to swallow oral medication (dasatinib must be swallowed whole)

• Must be available for protocol-required follow-up

Exclusion Criteria:

• Patients with a malignancy (other than the one treated in this study) which required radiotherapy or systemic therapy within the past 5 years

• Symptomatic brain metastasis that is either untreated or uncontrolled by surgery and or radiotherapy

• A known, prior, severe (NCI CTC Grade 3/Grade 4) history of hypersensitivity reaction to a drug formulated in Cremophor (polyoxyethylated castor oil)

• A serious, uncontrolled medical disorder or active infection including pericardial or pleural effusion of any grade,uncontrolled or significant cardiovascular disease,a bleeding disorder.