A Study Evaluating Efficacy of ABT-888 in Combination With Temozolomide in Metastatic Melanoma

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie (prior sponsor, Abbott)
• Treatments: Dacarbazine; Temozolomide; Veliparib

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.