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Study of Karenitecin (BNP1350) to Treat Malignant Melanoma

NCT00062491 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2020-03-12

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and efficacy of Karenitecin (BNP1350) as a treatment for Malignant Melanoma.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Crown Bioscience

    collaborator INDUSTRY

  • BioNumerik Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-05-31
Primary Completion
2003-06-30
Completion
2005-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00062491 on ClinicalTrials.gov