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| Sponsor: | Bristol-Myers Squibb |
|---|---|
| Information provided by: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00792558 |
Purpose
The purpose of this study is to find the maximum tolerated dose of BMS-817378 in subjects with advanced cancers
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Solid Tumors |
Drug: BMS-817378 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Single Group Assignment, Safety Study |
| Official Title: | A Phase I Ascending Multiple-Dose Study of BMS-817378 in Subjects With Advanced or Metastatic Solid Tumors |
| Estimated Enrollment: | 50 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | November 2010 |
| Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Single Arm: Experimental |
Drug: BMS-817378
Capsule, Oral, Dose escalation to a MTD from a starting dose of 25 mg, once daily, until disease progression/subject discontinuation
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Australia, South Australia | |
| Local Institution | |
| Adelaide, South Australia, Australia, 5000 | |
| Australia, Western Australia | |
| Local Institution | |
| Nedlands, Western Australia, Australia, 6009 | |
| Singapore | |
| Local Institution | |
| Singapore, Singapore, 169610 | |
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
| Responsible Party: | Bristol-Myers Squibb ( Study Director ) |
| Study ID Numbers: | CA195-001 |
| Study First Received: | November 17, 2008 |
| Last Updated: | November 12, 2009 |
| ClinicalTrials.gov Identifier: | NCT00792558 History of Changes |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration; Singapore: Ministry of Health |