Solid Tumors Using Ixabepilone and Dasatinib

Solid Tumor Clinical Trial

Official title:

A Phase I Study of Ixabepilone Combined With Dasatinib in Patients With Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00717704
• Other study ID #: WCI-2007-528
• Status: Completed
• Phase: Phase 1
• Start date: July 2008
• Est. completion date: May 2011

Study information

• Verified date: May 2012
• Source: Medstar Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

Drug:
• ixabepilone
by vein once every 3 weeks
• Dasatinib
by mouth once daily

Locations

Country	Name	City	State
United States	Washington Cancer Institute	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Medstar Health Research Institute	Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome is to determine the safety and toxicity of ixabepilone and dasatinib in combination in patients with metastatic or locally advanced/unresectable solid tumors that have progressed through standard therapy.	While on the drug combination, patients will be seen in the clinic every 3 weeks. These visits will assess the safety and tolerablility of the drug regimen. The drug combination continues until disease progression or unacceptable toxicity. When one of those two events occurs, the patient enters the followup phase. During the followup phase, the patient will return to the clinic every 4 weeks until drug-related toxicities resolve.	From study start until completion of study followup. This can vary greatly between patients, but on average patients received treatment for 4 cycles (12 weeks).
Secondary	The secondary outcome is to evaluate tumor response as a preliminary assessment of clinical activity.	Disease status will be monitored via diagnostic imaging every other cycle (every six weeks) until the patient is finished with drug combination. The drug combination continues until disease progression or unacceptable toxicity.	From start of the study until completion of the drug regimen. This can vary greatly between patients, but on average patients received treatment for 4 cycles (12 weeks).