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Sponsored by: |
BiPar Sciences |
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Information provided by: | BiPar Sciences |
ClinicalTrials.gov Identifier: | NCT00298675 |
The purpose of this study is to assess the safety, establish the maximum tolerated dose (MTD) and generate pharmacokinetic profiles of BSI-201 after IV administration in adult subjects with histologically documented advanced solid tumors that are refractory to standard therapy or for which no standard therapy is available. Additionally, the safety and tolerability and clinical response of BSI-201 + irinotecan will be investigated in patients with metastatic breast cancer in the phase 1b portion of the study.
Condition | Intervention | Phase |
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Tumors |
Drug: BSI-201 Drug: BSI-201 + irinotecan |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | A Phase 1/1b Dose Escalation Study Evaluating BSI-201 as a Single Agent and in Combination With Irinotecan in Subjects With Advanced Solid Tumors |
Estimated Enrollment: | 60 |
Study Start Date: | March 2006 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: BSI-201
iv, 2 x weekly
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2: Experimental |
Drug: BSI-201 + irinotecan
i.v.; 2x weekly for BSI-201, 1x weekly for irinotecan
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: BiPar Sciences | 650-635-6055 |
United States, Connecticut | |
Research Site | Not yet recruiting |
new haven, Connecticut, United States | |
United States, Texas | |
Research Site | Recruiting |
San Antonio, Texas, United States | |
Research Site | Recruiting |
Houston, Texas, United States |
Responsible Party: | BiPar Sciences ( VP Clinical Development ) |
Study ID Numbers: | BSI-201 20060101 |
Study First Received: | March 1, 2006 |
Last Updated: | May 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00298675 |
Health Authority: | United States: Food and Drug Administration |
Irinotecan |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Enzyme Inhibitors Antineoplastic Agents, Phytogenic Pharmacologic Actions |