Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Study of Karenitecin (BNP1350) to Treat Malignant Melanoma

This study has been completed.
Information provided by (Responsible Party):
BioNumerik Pharmaceuticals, Inc. Identifier:
First received: June 6, 2003
Last updated: October 8, 2015
Last verified: October 2015
The purpose of this study is to evaluate the safety and efficacy of Karenitecin (BNP1350) as a treatment for Malignant Melanoma.

Condition Intervention Phase
Drug: Karenitecin (BNP1350)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Trial of Karenitecin (BNP1350) in Patients With Malignant Melanoma

Resource links provided by NLM:

Further study details as provided by BioNumerik Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Overall Response [ Time Frame: start of treatment until progressive disease ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective Tumor Response Rate [ Time Frame: Start of treatment to date of response ] [ Designated as safety issue: No ]
  • Duration of Response [ Time Frame: Date of response to date of progressive disease ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: Randomization to date of death from any cause ] [ Designated as safety issue: No ]
  • Progression Free Survival [ Time Frame: Randomization to disease progression ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: May 2002
Study Completion Date: November 2005
Primary Completion Date: June 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Karenitecin (BNP1350)
Drug: Karenitecin (BNP1350)
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00062491

United States, Florida
For Information call 210-614-1701 for a site near you
Tampa, Florida, United States, 33612
Sponsors and Collaborators
BioNumerik Pharmaceuticals, Inc.
  More Information

Responsible Party: BioNumerik Pharmaceuticals, Inc. Identifier: NCT00062491     History of Changes
Other Study ID Numbers: KTN23106 
Study First Received: June 6, 2003
Last Updated: October 8, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on October 25, 2016