Study of Karenitecin (BNP1350) to Treat Malignant Melanoma

BioNumerik Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Neoplasm; Melanoma

Treatments: Drug: Karenitecin (BNP1350)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00062491

KTN23106

Details and patient eligibility

About

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

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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46 participants in 1 patient group

1

Experimental group

Description:

Karenitecin (BNP1350)

Treatment:

Drug: Karenitecin (BNP1350)