Back to resultsStudy of Karenitecin (BNP1350) to Treat Malignant Melanoma
Primary Purpose
Melanoma, Neoplasm
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Karenitecin (BNP1350)
Sponsored by
About this trial
This is an interventional treatment trial for Melanoma
Eligibility Criteria
Confirmed diagnosis of malignant melanoma Measurable disease Granulocytes ≥1,500/µl, Platelets ≥100,000/µl, Creatinine ≤ULN, Bilirubin ≤1.5 mg/dl, AST ≤2.5 x ULN No prior treatment with other camptothecin drug. ≥ 21 days since completion of prior chemotherapy, ≥6 weeks since prior Mitomycin-C ECOG Performance Status 0-1 Negative pregnancy test for female patients
Sites / Locations
- For Information call 210-614-1701 for a site near you
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Karenitecin (BNP1350)
Outcomes
Primary Outcome Measures
Overall Response
Secondary Outcome Measures
Objective Tumor Response Rate
Duration of Response
Overall Survival
Progression Free Survival
Full Information
NCT ID
NCT00062491
First Posted
June 6, 2003
Last Updated
March 10, 2020
Sponsor
BioNumerik Pharmaceuticals, Inc.
Collaborators
Crown Bioscience
1. Study Identification
Unique Protocol Identification Number
NCT00062491
Brief Title
Study of Karenitecin (BNP1350) to Treat Malignant Melanoma
Official Title
Phase 2 Trial of Karenitecin (BNP1350) in Patients With Malignant Melanoma
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
June 2003 (Actual)
Study Completion Date
November 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioNumerik Pharmaceuticals, Inc.
Collaborators
Crown Bioscience
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of Karenitecin (BNP1350) as a treatment for Malignant Melanoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma, Neoplasm
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Karenitecin (BNP1350)
Intervention Type
Drug
Intervention Name(s)
Karenitecin (BNP1350)
Intervention Description
Karenitecn (1.0 mg/m2) administered as a single daily 60-minute intravenous infusion for 5 consecutive days repeated every 21 days (1 treatment cycle). Patients who respond (CR< PR, SD) can continue treatment for 6 cycles, unless unacceptable toxicity develops. Treatment will be discontinued if progressive disease or unacceptable toxicity develops.
Primary Outcome Measure Information:
Title
Overall Response
Time Frame
start of treatment until progressive disease
Secondary Outcome Measure Information:
Title
Objective Tumor Response Rate
Time Frame
Start of treatment to date of response
Title
Duration of Response
Time Frame
Date of response to date of progressive disease
Title
Overall Survival
Time Frame
Randomization to date of death from any cause
Title
Progression Free Survival
Time Frame
Randomization to disease progression
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Confirmed diagnosis of malignant melanoma
Measurable disease
Granulocytes ≥1,500/µl, Platelets ≥100,000/µl, Creatinine ≤ULN, Bilirubin ≤1.5 mg/dl, AST ≤2.5 x ULN
No prior treatment with other camptothecin drug.
≥ 21 days since completion of prior chemotherapy, ≥6 weeks since prior Mitomycin-C
ECOG Performance Status 0-1
Negative pregnancy test for female patients
Facility Information:
Facility Name
For Information call 210-614-1701 for a site near you
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of Karenitecin (BNP1350) to Treat Malignant Melanoma
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