Solid Tumors Using Ixabepilone and Dasatinib

Completed · Phase 1

Conditions studied: Solid Tumor

In brief

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.

Key facts

Study ID

NCT00717704

Run by

Medstar Health Research Institute

People needed

19

Starts

2008-07-01

Expected to finish

2011-05-01

Last updated by the study team

2020-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Washington Cancer Institute — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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