Study of Karenitecin (BNP1350) to Treat Malignant Melanoma

Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00062491
• Other study ID #: KTN23106
• Status: Completed
• Phase: Phase 2
• Start date: May 2002
• Est. completion date: November 2005

Study information

• Verified date: March 2020
• Source: BioNumerik Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: November 2005
• Est. primary completion date: June 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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

Related Conditions & MeSH terms

• Melanoma
• Neoplasm

Intervention

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.

Locations

Country	Name	City	State
United States	For Information call 210-614-1701 for a site near you	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
BioNumerik Pharmaceuticals, Inc.	Crown Bioscience, Inc. became karenitecin IND 057250 Sponsor on April 8, 2019

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response		start of treatment until progressive disease
Secondary	Objective Tumor Response Rate		Start of treatment to date of response
Secondary	Duration of Response		Date of response to date of progressive disease
Secondary	Overall Survival		Randomization to date of death from any cause
Secondary	Progression Free Survival		Randomization to disease progression