Study of Dasatinib(BMS-354825) in Patients With Solid Tumors - Tabular View

Tracking Information

First Received Date ^ICMJE

June 19, 2006

Last Updated Date

August 5, 2009

Start Date ^ICMJE

January 2007

Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To determine the maximum tolerated dose (MTD) or the maximum accepted dose (MAD) for BMS-354825 in patients with solid tumors (including relapsed disease) that are refractory to standard therapies or for which no effective standard therapy exists. [ Time Frame: at the end of the study ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00339144 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To assess the safety and tolerablitiy and pharmacokinetic profile of BMS-354825 when administered once daily (QD), evaluate the potential pharmacodynamic markers, obtain preliminary efficacy information [ Time Frame: at the end of the study ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Study of Dasatinib(BMS-354825) in Patients With Solid Tumors

Official Title ^ICMJE

A Phase I Study of BMS-354825 in Patients With Solid Tumors

Brief Summary

The primary objective of this study is to determine the maximum tolerated dose (MTD) or the maximum administered dose(MAD) of Dasatinib (BMS-354825) in patients in Japan.

Detailed Description

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Tumors

Intervention ^ICMJE

Drug: 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

Completed

Enrollment ^ICMJE

Completion Date

September 2008

Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Performance status (general conditions) specified by the Eastern Cooperative Oncology Group: 0-2
Histologic or cytologic diagnosis of a solid tumor which has progressed on or following standard therapies (including relapsed disease) or for which no standard therapy exists.
men and women, ages 20 and over
women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 3 months after the study in such a manner that the risk of pregnancy is minimized
Adequate hepatic function

Exclusion Criteria:

Subjects who are eligible and willing to undergo transplantation at pre- study.
Women who are pregnant or breastfeeding with known brain metastasis or symptoms of brain metastasis
Uncontrolled or significant bleeding disorder unrelated to a primary tumor
Dementia or mental illness that would prohibit understanding or giving informed consent.
Severe allergy to drugs required fro appropriate supportive care of patients in this study.
History of gastrointestinal surgery or of any digestive disorder which has the potential to inhibit absorption of the study drug.
Pleural effusion > Grade 1
Patient with dysphagia
Does not agree to blood/blood products transfusion(s)
Donated blood over 200 mL within 4 weeks prior to the start of study therapy
Medication that known to have a risk of causing Torsade de pointes
Subjects who are compulsorily detained for legal reasons or treatment of either a psychiatric or physical (e.g., infectious disease)illness must not be enrolled into this study

Gender

Both

Ages

20 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT ID ^ICMJE

NCT00339144

Responsible Party

Study Director, Bristol-Myers Squibb

Study ID Numbers ^ICMJE

CA180-058

Study Sponsor ^ICMJE

Bristol-Myers Squibb

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Bristol-Myers Squibb

Information Provided By

Bristol-Myers Squibb

Verification Date

July 2008

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