A Study Evaluating Efficacy of ABT-888 in Combination With Temozolomide in Metastatic Melanoma
Condition: Melanoma; Metastatic Melanoma; Skin Cancer
MeSH terms: Melanoma; Skin Neoplasms
Intervention: temozolomide; ABT-888; Placebo
Intervention description: temozolomide capsule administered orally once daily for 5 days every 28 days; ABT-888 capsule administered orally twice daily for 7 days every 28 days; Placebo for ABT-888 capsule administered orally twice daily for 7 days every 28 days
Intervention MeSH terms: Temozolomide; Veliparib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 346.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Temozolomide; Skin cancer; Melanoma; Metastatic Melanoma; ABT-888; MM

Summary:

      The purpose of this study is to evaluate the efficacy of ABT-888 in combination with
      temozolomide versus temozolomide alone in subjects with metastatic melanoma.
    

Eligibility criteria:

        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 international normalized ratio (INR) < 1.5.

          -  Subject's with significant fluid retention may be allowed at the discretion of the
             investigator.

          -  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 central nervous system metastases or leptomeningeal disease.

          -  Prior treatment with Dacarbazine (DTIC) or Temozolomide (TMZ).

          -  Prior DNA damaging agents or cytotoxic chemotherapy.

          -  Prior Whole Brain Radiation Therapy (with exceptions).

          -  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.