A Study of Whole Brain Radiation Therapy (WBRT) with Veliparib or without Veliparib in patients with Brain Metastases from Non-Small Cell Lung Cancer.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 330

Inclusion Criteria

Subject must be = 18 years of age;
Subject must have cytologically or histologically confirmed NSCLC;
Subject must have brain metastases as demonstrated on a MRI brain scan;
Subject must be eligible for WBRT;
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 250

Exclusion Criteria

Subject was diagnosed with brain metastasis >28 days prior to Treatment Day 1;
Subject received any prior form of cranial radiation and/or neurosurgery for brain metastasis;
Subject has a Karnofsky Performance Score (KPS) of < 70;
Subject has significant dyspnea requiring supplemental oxygen therapy;
Subject has liver metastases (restaging is not required for known liver metastasis);
Subject has more than 2 sites (organ systems) of metastases from NSCLC with the exception of the following: intra-cranial sites of metastasis from NSCLC, thoracic sites of metastasis from NSCLC, and bone metastasis;
Subject has leptomeningeal metastases or subarachnoid spread of tumor as demonstrated on a baseline MRI brain scan;
Subject's last dose of chemotherapy or investigational therapy was = 7 days prior to Treatment Day 1;
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 metastasis 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 PARP inhibitor as an investigational agent;
Subject has clinically significant and uncontrolled major medical condition(s)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess whether the addition of Veliparib when given during whole brain radiation therapy (WBRT) improves Overall Survival (OS) for subjects with brain metastases from Non-small Cell Lung Cancer (NSCLC).;Secondary Objective: To assess Safety, Best Tumor Response Rate, Time to Intracranial Progression (Radiographic), and Time to Clinical Brain Metastasis Progression. Also to evaluate whether addition of twice daily oral Veliparib during WBRT delays deterioration of neurological symptoms, delays functional decline, and improves subject quality of life.;Primary end point(s): The primary endpoint for this study is Overall Survival;Timepoint(s) of evaluation of this end point: Overall Survival for a given subject will be defined as the number of days from the date the subject was randomized to the date of the subject's death

Secondary Outcome Measures

Name	Time	Method

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