Solid Tumors Using Ixabepilone and Dasatinib - Full Text View

Sponsor:	Washington Hospital Center
Collaborator:	Bristol-Myers Squibb
Information provided by:	Washington Hospital Center
ClinicalTrials.gov Identifier:	NCT00717704

Purpose

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).

Participants will be placed in 1 of 2 groups. Placement into group 2 will not begin until all spaces in group 1 are filled.

Group 1 will receive ixabepilone by vein once every three weeks as well as dasatinib by mouth once daily.

Group 2 will receive ixabepilone on day 1 of a 3-week cycle (21 days). Dasatinib will be taken twice daily in group 2.

Condition	Intervention	Phase
Solid Tumor	Drug: ixabepilone and dasatinib	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Pharmacokinetics Study
Official Title:	A Phase I Study of Ixabepilone Combined With Dasatinib in Patients With Solid Tumors

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Ixabepilone Dasatinib

U.S. FDA Resources

Further study details as provided by Washington Hospital Center:

Primary Outcome Measures:

The primary outcome is dichotomous - either induced dose limiting toxicity or not [ Time Frame: yearly ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	July 2008
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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 a higher dosage. If side effects are intolerable, then the dose will be lowered.

Group 1 will receive ixabepilone on day 1 of a 3-week cycle (21 days). In other words, ixabepilone will be given through a vein once every three weeks and dasatinib by mouth once daily.

Group 2 will receive ixabepilone on day 1 of a 3-week cycle (21 days). Dasatinib will be taken twice daily in group 2.

Approximately 30 participants will be placed in group 1, and 30 participants will be placed in group 2.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00717704

Locations

United States, District of Columbia
Washington Cancer Institute	Recruiting
Washington, District of Columbia, United States, 20010
Contact: Becky K Montalvo 202-877-8839 wci.research@medstar.net
Sub-Investigator: David J Perry, MD
Sub-Investigator: Karen L Smith, MD, MPH
Sub-Investigator: Dennis A Priebat, MD

Sponsors and Collaborators

Washington Hospital Center

Bristol-Myers Squibb

Investigators

Principal Investigator:

Sandra M Swain, MD

Washington Hospital Center

More Information

No publications provided

Responsible Party:	Washington Cancer Institute ( Sandra M. Swain, MD , Principal Investigator )
Study ID Numbers:	WCI-2007-528
Study First Received:	July 15, 2008
Last Updated:	December 16, 2008
ClinicalTrials.gov Identifier:	NCT00717704 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Washington Hospital Center:

Malignant solid tumor
Phase 1
Dose escalation
Metastatic or locally advanced/unresectable
Disease progression through standard therapy

Additional relevant MeSH terms:

Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Dasatinib
Epothilones

Mitosis Modulators
Tubulin Modulators
Enzyme Inhibitors
Antimitotic Agents
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 04, 2010