Clinical trial NCT00717704: Solid Tumors Using Ixabepilone and Dasatinib
Official title: A Phase I Study of Ixabepilone Combined With Dasatinib in Patients With Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumor
Keywords: Malignant solid tumor
Phase 1
Dose escalation
Metastatic or locally advanced/unresectable
Disease progression through standard therapy
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2008-07-17
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: 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.
timeFrame: 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 outcomes:
measure: The secondary outcome is to evaluate tumor response as a preliminary assessment of clinical activity.
timeFrame: 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).
Other outcomes:
Locations:
city: Washington
country: United States
facility: Washington Cancer Institute
state: District of Columbia
Study officials:
affiliation: Medstar Health Research Institute
name: Sandra M Swain, MD
role: PRINCIPAL_INVESTIGATOR
References: