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

Purpose

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.

Condition	Intervention	Phase
Tumors	Drug: dasatinib	Phase I

MedlinePlus related topics:

Cancer

ChemIDplus related topics:

Dasatinib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	12
Study Start Date:	January 2007
Estimated Study Completion Date:	October 2008
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A1: Experimental	Drug: dasatinib tablets, Oral, 100 mg, once daily for 4 weeks
A2: Experimental	Drug: dasatinib tablets, Oral, 150 mg, once daily, 4 weeks
A3: Experimental	Drug: dasatinib tablets, Oral, 200 mg, once daily for 4 weeks
A4: Experimental	Drug: dasatinib tablets, Oral, 250 mg, once daily for 4 weeks

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00339144

Locations


Japan, Osaka
	Local Institution
	Osakasayama City, Osaka, Japan, 589-0014

Japan, Tokyo
	Local Institution
	Koto-Ku, Tokyo, Japan, 135-0063

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators


Study Director:	Bristol-Myers Squibb	Bristol-Myers Squibb

More Information

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CA180-058
First Received:	June 19, 2006
Last Updated:	September 26, 2008
ClinicalTrials.gov Identifier:	NCT00339144
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Bristol-Myers Squibb:

Solid tumors (including relapsed disease) that are refractory to standard therapies or for which no effective standard therapy exists

Study placed in the following topic categories:

Dasatinib

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action

Enzyme Inhibitors

Protein Kinase Inhibitors

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 07, 2008

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00339144