Conditions: Melanoma
Keywords: metastatic second-line
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 336
Healthy volunteers: no

Brief summary:
The primary purpose of this study was to see how tasisulam-sodium affected metastatic melanoma when compared against paclitaxel as measured by overall survival.

Detailed description:

Arms:
arm 1: Individualized tasisulam-sodium dose was dependent on participant's height, weight, and gender. Dose was adjusted based on laboratory parameters. Treatment was administered intravenously on Day 1 of a 28-day cycle, until disease progression. arm 2: Paclitaxel 80 milligrams per square meter (mg/m\^2) administered intravenously on Days 1, 8, and 15 of a 28-day cycle, until disease progression

Interventions: intervention 1: Tasisulam-sodium intervention 2: Paclitaxel
Intervention descriptions: intervention 1: Administered intravenously on Day 1 of a 28-day cycle, until disease progression. intervention 2: 80 mg/m\^2 administered intravenously on Days 1, 8, and 15 of a 28-day cycle, until disease progression

Protocol document: