A Study of Tasisulam-sodium Versus Paclitaxel as Treatment for Metastatic Melanoma (SUMMIT-1)

Lilly

Status and phase: Terminated; Phase 3

Conditions: Melanoma

Treatments: Drug: Tasisulam-sodium; Drug: Paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT01006252

13101

H8K-MC-JZAO (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 336 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have a histologic and/or cytologic diagnosis of metastatic melanoma (Stage IV).
• Have the presence of evaluable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.0).
• Have a performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) Scale.
• Have progressed after 1 previous systemic treatment containing dacarbazine or temozolomide for metastatic melanoma.
• Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, immunotherapy, or other investigational therapy for at least 30 days (6 weeks for mitomycin-C or nitrosoureas) before study enrollment and recovered from the acute effects of therapy (except alopecia).
• Have a serum albumin level greater than or equal to 3.0 grams per deciliter (g/dL) or greater than or equal to 30 grams per liter (g/L).

Exclusion criteria

• Have received greater than or equal to 2 previous chemotherapy-containing systemic treatment regimens for metastatic melanoma. An immunotherapy or antibody-based regimen (including biologic agents and vaccination-based treatments), or treatment with a targeted agent (for example, BRAF or c-Kit inhibitor is not counted as a prior treatment regimen for determining study eligibility, unless either was combined with a cytotoxic drug).
• Have active central nervous system (CNS) or leptomeningeal metastasis (brain metastasis) at the time of study entry. Participants with signs or symptoms of neurological compromise should have appropriate radiographic imaging performed before study entry to rule out occult brain metastasis. Participants with a history of a solitary CNS metastasis previously treated with curative intent (for example, stereotactic radiation or surgery) and not requiring steroids are eligible.
• Are receiving warfarin.
• Have primary ocular or mucosal melanoma.
• Any previous treatment with paclitaxel or a paclitaxel-containing regimen for metastatic melanoma.
• Have serious concomitant disorders, including active bacterial, fungal, or viral infection, incompatible with the study (at the discretion of the investigator).
• Have previously completed or withdrawn from this study or any other study investigating tasisulam-sodium.
• Have a known hypersensitivity to paclitaxel or Cremophor EL (polyoxyethylated castor oil).
• Are pregnant or lactating.
• Have received a recent (within 30 days before enrollment) or are receiving concurrent yellow fever vaccination.
• Have known positive test results in human immunodeficiency virus (HIV), hepatitis B surface antigen (HBSAg), or hepatitis C antibodies (HCAb).
• Are unable to withhold dosing of non-steroidal anti-inflammatory drugs (NSAIDs) or proton-pump inhibitors (PPIs) for at least 72 hours before and after treatment with tasisulam-sodium.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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336 participants in 2 patient groups

Tasisulam-sodium

Experimental group

Description:

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.

Treatment:

Drug: Tasisulam-sodium

Paclitaxel

Active Comparator group

Description:

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

Treatment:

Drug: Paclitaxel