Study of Karenitecin (BNP1350) to Treat Malignant Melanoma

Phase 2

Completed

• Conditions: Melanoma; Neoplasm
• Interventions: Drug: Karenitecin (BNP1350)

• Registration Number: NCT00062491
• Lead Sponsor: BioNumerik Pharmaceuticals, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2002-05
• Primary Completion: 2003-06
• Study First Submitted: 2003-06-06
• Study First Submitted QC: 2003-06-11
• Study First Posted: 2003-06-12
• Study Completion: 2005-11
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-10
• Last Update Posted: 2020-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Karenitecin (BNP1350)	Karenitecin (BNP1350)

Primary Outcome Measures

Name	Time	Method
Overall Response	start of treatment until progressive disease

Secondary Outcome Measures

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

Trial Locations

Locations (1)

For Information call 210-614-1701 for a site near you; 🇺🇸 Tampa, Florida, United States