A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study Evaluating the Efficacy of ABT-888 in Combination With Temozolomide Versus Temozolomide Alone in Subjects With Metastatic Melanoma

Inclusion Criteria:

- Histologically (or cytologically) confirmed metastatic melanoma.

- Unresectable Stage III or Stage IV metastatic melanoma.

- Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

- Subjects with no history of brain metastases demonstrated by a baseline MRI,or
subjects with a history of previously treated brain metastases who have history of
operable/SRS treatable brain metastases and completed surgical resection/stereotactic
radiosurgery with or without adjuvant whole brain radiation at least 28 days prior to
Day 1.

- have baseline MRI that shows no evidence of active intercranial disease

- have discontinued taking medications for symptom management of brain metastases at
least 7 days prior to Day 1

- 28 days since prior anti-cancer therapy.

- Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-1.

- Adequate hematologic, renal and hepatic function.

- Partial Thromboplastin Time (PTT) is <= 1.5 x upper normal limit of institution's
normal range and INR < 1.5.

- Subject's with significant fluid retention may be allowed at the discretion of the
PI.

- Life expectancy > 12 weeks.

- Females must not be pregnant.

- Voluntarily signed informed consent.

Exclusion Criteria:

- Lactate Dehydrogenase (LDH) > 2 x Upper Limit of Normal (ULN).

- Ocular malignant melanoma.

- History of CNS metastases or leptomeningeal disease.

- Prior treatment with Dacarbazine (DTIC) or Temozolomide (TMZ).

- Prior DNA damaging agents or cytotoxic chemotherapy.

- Prior Whole Brain Radiation Therapy.

- Received an investigational agent within 28 days of study.

- History of seizure disorder and/or taking medication for seizure disorder.

- Active malignancy within the past 5 years, except cervical cancer in situ, in situ
carcinoma of the bladder or non-melanoma carcinoma of the skin.

- Medical condition that would cause a high risk for toxicities.