A Study Evaluating Efficacy of ABT-888 in Combination With Temozolomide in Metastatic Melanoma
Status: | Completed |
---|---|
Conditions: | Skin Cancer, Skin Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - 99 |
Updated: | 4/21/2016 |
Start Date: | February 2009 |
End Date: | January 2016 |
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.
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.
We found this trial at
25
sites
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