A Study of Tasisulam-sodium Versus Paclitaxel as Treatment for Metastatic Melanoma
Condition: Melanoma
MeSH terms: Melanoma
Intervention: Tasisulam-sodium; Paclitaxel
Intervention description: Administered intravenously on Day 1 of a 28-day cycle, until disease progression.; 80 mg/m^2 administered intravenously on Days 1, 8, and 15 of a 28-day cycle, until disease progression
Intervention MeSH terms: Paclitaxel
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 336.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: metastatic; second-line

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.
    

Eligibility criteria:

        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.