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


Phase 2
18 Years
N/A
Not Enrolling
Both
Melanoma, Neoplasm

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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 youTampa, Florida  33612