Solid Tumors Using Ixabepilone and Dasatinib

NCT ID: NCT00717704

Last Updated: 2020-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2011-05-31

Brief 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.

Conditions

Solid Tumor

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

All participants will receive ixabepilone by vein once every three weeks as well as dasatinib by mouth once daily. All participants will receive the study drugs at a baseline dose. If the side effects are minimal and tolerable, the next cycle of study drugs will be given at same dosage. If side effects are intolerable, then the dose will be lowered.

Group Type: EXPERIMENTAL

ixabepilone

Intervention Type: DRUG

by vein once every 3 weeks

Dasatinib

Intervention Type: DRUG

by mouth once daily

Interventions

ixabepilone

by vein once every 3 weeks

Intervention Type: DRUG

Dasatinib

by mouth once daily

Intervention Type: DRUG

Other Intervention Names

ixempra; Sprycel; BMS-354825

Eligibility 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.

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

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

Medstar Health Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sandra M Swain, MD

Role: PRINCIPAL_INVESTIGATOR

Medstar Health Research Institute

Locations

Washington Cancer Institute

Washington D.C., District of Columbia, United States

Countries

United States

Other Identifiers

WCI-2007-528

Identifier Type: -

Identifier Source: org_study_id