Clinical trial · Interventional
Study of Karenitecin (BNP1350) to Treat Malignant Melanoma
Phase 2 Trial of Karenitecin (BNP1350) in Patients With Malignant Melanoma
NCT00062491CI-TRIAL-00043970completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the safety and efficacy of Karenitecin (BNP1350) as a treatment for Malignant Melanoma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Karenitecin (BNP1350) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- Karenitecin (BNP1350)
- interventionNames
- Drug: Karenitecin (BNP1350)
Primary outcomes (1)
- measure
- Overall Response
- timeFrame
- start of treatment until progressive disease
Secondary outcomes (4)
- measure
- Objective Tumor Response Rate
- timeFrame
- Start of treatment to date of response
- measure
- Duration of Response
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
* 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
References
Publications (0)
Data not yet available
No reference posted for this study.