A Study of Tasisulam in Treating Participants With Malignant Melanoma

Lilly

Status and phase

Completed

Phase 2

Conditions

Metastatic Melanoma

Treatments

Drug: tasisulam

Study type

Interventional

Funder types

Industry

Identifiers

NCT00383292

10409 (Registry Identifier)

H8K-MC-JZAF (Other Identifier)

Details and patient eligibility

About

The primary purpose of this study is to determine the objective response rate (complete and partial response) for participants who receive tasisulam after one prior systemic treatment for unresectable or metastatic melanoma.

Full description

Participants will receive a 2-hour intravenous infusion of study drug (tasisulam) once every 28 days. Radiological imaging scans will be performed before the first dose of study drug and then after every other treatment. Participants will be assessed for clinical progression at every visit and for response approximately every 56 days (every other cycle).

Enrollment

130 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of malignant melanoma that is unresectable or metastatic (Stage III or IV)
Have received 1 previous systemic treatment regimen for unresectable or metastatic melanoma. An immunotherapy or antibody-based regimen (including vaccination-based treatments) is not counted as a prior treatment regimen for determining study eligibility, unless it was combined with a chemotherapeutic or targeted anti-cancer drug.
Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, immunotherapy, or other investigational therapy for at least 30 days

Exclusion criteria

Serious pre-existing medical conditions
Have received two or more previous treatment regimens for unresectable or metastatic melanoma
Have a second primary cancer (unless disease-free to more than 2 years)
Active treatment with Warfarin (Coumadin)
Primary ocular or mucosal melanoma