Solid Tumors Using Ixabepilone and Dasatinib - Tabular View

Tracking Information

First Received Date ^ICMJE

July 15, 2008

Last Updated Date

December 16, 2008

Start Date ^ICMJE

July 2008

Estimated Primary Completion Date

October 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

The primary outcome is dichotomous - either induced dose limiting toxicity or not [ Time Frame: review prior to each dose escalation ] [ Designated as safety issue: Yes ]

Change History

Complete list of historical versions of study NCT00717704 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Solid Tumors Using Ixabepilone and Dasatinib

Official Title ^ICMJE

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

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).

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.

Detailed Description

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Pharmacokinetics Study

Condition ^ICMJE

Solid Tumor

Intervention ^ICMJE

Drug: ixabepilone and dasatinib

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

February 2010

Estimated Primary Completion Date

October 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00717704

Responsible Party

Sandra M. Swain, MD , Principal Investigator, Washington Cancer Institute

Study ID Numbers ^ICMJE

WCI-2007-528

Study Sponsor ^ICMJE

Washington Hospital Center

Collaborators ^ICMJE

Bristol-Myers Squibb

Investigators ^ICMJE

Principal Investigator:

Sandra M Swain, MD

Washington Hospital Center

Information Provided By

Washington Hospital Center

Verification Date

December 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP