Study of Karenitecin (BNP1350) to Treat Malignant Melanoma

March 10, 2020 updated by: BioNumerik Pharmaceuticals, Inc.

Phase 2 Trial of Karenitecin (BNP1350) in Patients With Malignant Melanoma

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • For Information call 210-614-1701 for a site near you

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Response
Time Frame: start of treatment until progressive disease
start of treatment until progressive disease

Secondary Outcome Measures

Outcome Measure
Time Frame
Objective Tumor Response Rate
Time Frame: Start of treatment to date of response
Start of treatment to date of response
Duration of Response
Time Frame: Date of response to date of progressive disease
Date of response to date of progressive disease
Overall Survival
Time Frame: Randomization to date of death from any cause
Randomization to date of death from any cause
Progression Free Survival
Time Frame: Randomization to disease progression
Randomization to disease progression

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioNumerik Pharmaceuticals, Inc.

Collaborators

Crown Bioscience

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2002

Primary Completion (Actual)

June 1, 2003

Study Completion (Actual)

November 1, 2005

Study Registration Dates

First Submitted

June 6, 2003

First Submitted That Met QC Criteria

June 11, 2003

First Posted (Estimate)

June 12, 2003

Study Record Updates

Last Update Posted (Actual)

March 12, 2020

Last Update Submitted That Met QC Criteria

March 10, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KTN23106

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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