A Randomized Phase 3 Study of Tasisulam Administered as an Intravenous Infusion on Day 1 of a 28-Day Cycle vs. Paclitaxel as Second-Line Treatment in Patients With Metastatic Melanoma

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 to 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 g/dL or greater than or equal
to 30 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 (e.g 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. Patients with signs or symptoms of
neurological compromise should have appropriate radiographic imaging performed before
study entry to rule out occult brain metastasis. Patients with a history of a
solitary CNS metastasis previously treated with curative intent (e.g., 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- Have previously completed or withdrawn from this study or any other study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

- 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.