Status:
COMPLETED
A Study Evaluating Efficacy of ABT-888 in Combination With Temozolomide in Metastatic Melanoma
Lead Sponsor:
AbbVie (prior sponsor, Abbott)
Conditions:
Melanoma
Metastatic Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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
- 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
- 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.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
346 Patients enrolled
Trial Details
Trial ID
NCT00804908
Start Date
February 1 2009
End Date
January 1 2016
Last Update
June 6 2018
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