Phase 2 Trial of Karenitecin (BNP1350) in Patients With Malignant Melanoma
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Melanoma, Neoplasm
Both
Melanoma, Neoplasm
Trial Information
Phase 2 Trial of Karenitecin (BNP1350) in Patients With Malignant Melanoma
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall Response
Outcome Time Frame:
start of treatment until progressive disease
Safety Issue:
No
Authority:
United States: Food and Drug Administration
Study ID:
KTN23106
NCT ID:
NCT00062491
Start Date:
May 2002
Completion Date:
November 2005
Related Keywords:
- Melanoma
- Neoplasm
- Neoplasms
- Melanoma
Name | Location |
|---|---|
| For Information call 210-614-1701 for a site near you | Tampa, Florida 33612 |
