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Sponsored by: |
BioNumerik Pharmaceuticals, Inc. |
Information provided by: | BioNumerik Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00062478 |
The purpose of this study is to evaluate safety and efficacy ofKarenitecin (BNP1350) as a treatment of adults with brain tumors.
Condition | Intervention | Phase |
Brain Neoplasms Malignant Neoplasms, Brain Brain Tumors |
Drug: Karenitecin (BNP1350) |
Phase II |
MedlinePlus related topics: | Brain Cancer Cancer |
ChemIDplus related topics: | Karenitecin |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase 2 Treatment of Adults With Primary Malignant Glioma With Karenitecin |
Enrollment: | 40 |
Study Start Date: | October 2001 |
Primary Completion Date: | August 2002 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
Karenitecin for intravenous use
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Drug: Karenitecin (BNP1350)
Karenitecin 1.0 mg/m2 administered as a single 60-minute IV infusion daily for five consecutive days. The cycle is repeated every 21 days until occurrence of progressive disease or unacceptable toxicity.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Responsible Party: | BioNumerik ( BioNumerik (Chief Executive Officer) ) |
Study ID Numbers: | KTN20405 |
First Received: | June 6, 2003 |
Last Updated: | May 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00062478 |
Health Authority: | United States: Food and Drug Administration |
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