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| Sponsor: | Bristol-Myers Squibb |
|---|---|
| Information provided by: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00099606 |
Purpose
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, effect of food, and continue exploratory research of BMS-354825 in patients with solid tumors not responding to standard treatment, or for which no effective standard treatment exists.
| Condition | Intervention | Phase |
|---|---|---|
|
Neoplasms |
Drug: Dasatinib |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Dose-Escalation Study of BMS-354825 in Patients With Refractory Solid Tumors |
| Estimated Enrollment: | 60 |
| Study Start Date: | July 2004 |
| Study Completion Date: | July 2007 |
| Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A1 |
Drug: Dasatinib
Tablets, Oral, Dose Finding Study - Range was 35 mg BID, 5 days on/2 days off - 120 mg BID Continuous Daily Dosing, Once daily, Patients remained on study until treatment discontinuation due to unacceptable toxicity, disease progression or death.
Other Name: Sprycel
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal [defined as amenorrhea >=12 consecutive months; or women on hormone replacement therapy (HRT) with documented serum follicle stimulating hormone (FSH) level >35 mIU/mL]. Even women who are using oral, implanted or injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy), should be considered to be of child bearing potential.
WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of study medication.
Exclusion Criteria:
Contacts and Locations| United States, Massachusetts | |
| Local Institution | |
| Boston, Massachusetts, United States | |
| United States, Michigan | |
| Local Institution | |
| Detroit, Michigan, United States | |
| United Kingdom | |
| Local Institution | |
| Glasgow, Strathclyde, United Kingdom | |
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
| ClinicalTrials.gov Identifier: | NCT00099606 History of Changes |
| Other Study ID Numbers: | CA180-003 |
| Study First Received: | December 17, 2004 |
| Last Updated: | April 18, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Neoplasms Dasatinib Protein Kinase Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |