Comparison of Veliparib and Whole Brain Radiation Therapy (WBRT) Versus Placebo and WBRT in Adults With Brain Metastases From Non-Small Cell Lung Cancer
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Keep this study
Lead
AbbVie (prior sponsor, Abbott)
Age
18–99
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Subject must have cytologically or histologically confirmed non-small cell lung cancer
Subject must have brain metastases demonstrated on a magnetic resonance imaging (MRI) brain scan.
Subject must be eligible for treatment with WBRT
Subject must have had adequate hematologic, renal, and hepatic function.
You may not be if
Subject is diagnosed with brain metastases greater than 28 days prior to Day 1
Subject received any prior form of cranial radiation and/or neurosurgery for their brain metastases
Subject's last dose of anti-cancer therapy or investigational therapy was less than or equal to 7 days prior to Day 1
Subject has a Karnofsky Performance Score of less than 70
Subject has significant dyspnea requiring supplemental oxygen therapy
Subject has liver metastases (restaging is not required for known liver metastases)
Subject has more than 2 sites (organ systems) of metastases from non-small cell lung cancer with the exception of intra-cranial sites of metastases from non-small cell lung cancer, thoracic sites of metastases from non-small cell lung cancer and bone metastases
Subject has leptomeningeal metastases or subarachnoid spread of tumor
Subject has unresolved or unstable, serious toxicity from prior administration of another investigational drug and/or prior anti-cancer treatment
Subject has a known seizure disorder that is uncontrolled, or has seizures occurring greater than or equal to 3 times a week over the past month. Subjects presenting with symptoms of seizures from the brain metastases are eligible; however he/she should receive adequate anti-seizure medication prior to study treatment
Subject is pregnant or lactating
Subject has previously been treated with a poly-(ADP-ribose)-polymerase inhibitor as an investigational agent
Subject has clinically significant and uncontrolled major medical condition(s)
Subject has a history of another active cancer within the past 5 years except: cervical cancer in situ, in situ carcinoma of the bladder, basal or squamous cell carcinoma of the skin or other cancer in situ that is considered cured
Clareo Health | Comparison of Veliparib and Whole Brain Radiation Therapy (WBRT) Versus Placebo and WBRT in Adults With Brain Metastases From Non-Small Cell Lung Cancer
