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

Brief Summary

Official Title: “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”

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.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
  • Study Primary Completion Date: December 2015

Interventions Used in this Clinical Trial

  • Drug: temozolomide
    • 150 mg/m2 temozolomide daily for 5 days every 28 days
  • Drug: ABT-888
    • Either 20 mg or 40 mg BID for 7 days every 28 days
  • Other: Placebo
    • Placebo BID for 7 days every 28 days

Arms, Groups and Cohorts in this Clinical Trial

  • Active Comparator: 1
    • TMZ + ABT-888 at 20 mg BID
  • Active Comparator: 2
    • TMZ + ABT-888 at 40 mg BID
  • Placebo Comparator: 3
    • TMZ + Placebo

Outcome Measures for this Clinical Trial

Primary Measures

  • Progression-Free Survival
    • Time Frame: Radiographic evaluation every 2 months, clinical evaluation monthly
      Safety Issue?: No

Secondary Measures

  • Overall Survival
    • Time Frame: Every 4 weeks or as needed after subject is registered as off-study, up to 18 months
      Safety Issue?: No
  • 12-month Survival Rate
    • Time Frame: Every cycle (28 days)
      Safety Issue?: No
  • 6-month Progression Free Survival Rate
    • Time Frame: Every cycle (28 days)
      Safety Issue?: No
  • Time to Disease Progression
    • Time Frame: Every cycle (28 days)
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 99 Years

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • AbbVie (prior sponsor, Abbott)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Mark D McKee, MD, Study Director, AbbVie


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