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Sponsored by: |
Bristol-Myers Squibb |
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Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00773344 |
The primary purpose(s) of this study is to determine the highest tolerated dose of tanespimycin and to determine anti-tumor activity (via objective response rate) of tanespimycin in patients with breast cancer who have not previously responded to Herceptin
Condition | Intervention | Phase |
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Solid Tumors Breast Cancer |
Drug: Tanespimycin |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase 1/2 Clinical Trial of the Combination of Trastuzumab (Herceptin) and Tanespimycin |
Estimated Enrollment: | 57 |
Study Start Date: | November 2004 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A1: Experimental |
Drug: Tanespimycin
Solution, IV, Weekly two hour infusion, 4-cycles until disease progression or DLT This is a one-arm study with 4 fixed doses of Tanespimycin (225mg/m2, 300mg/m2, 375mg/m2 and 400mg/m2) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Platelet count >= 75 x 10*9* /L
Exclusion Criteria:
United States, Arizona | |
Premiere Oncology Of Arizona | |
Scottsdale, Arizona, United States, 85260 | |
Arizona Cancer Center | |
Tucson, Arizona, United States, 85724 | |
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 | |
United States, Washington | |
Seattle Cancer Care Alliance | |
Seattle, Washington, United States, 98109 |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Bristol-Myers Squibb ( Study Director ) |
Study ID Numbers: | CA200-001, KAG 122 |
Study First Received: | October 15, 2008 |
Last Updated: | January 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00773344 |
Health Authority: | United States: Food and Drug Administration |
Solid Tumors (dose escalation/Phase 1) Breast Cancer (recommended dose phase/Phase 2) |
Skin Diseases Trastuzumab Breast Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |