A Study of Whole Brain Radiation Therapy (WBRT) with Veliparib or without Veliparib in patients with Brain Metastases from Non-Small Cell Lung Cancer.
- Conditions
- Brain metastases from NSCLCMedDRA version: 14.1 Level: LLT Classification code 10006128 Term: Brain metastases System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-003618-18-NO
- Lead Sponsor
- Abbott GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 307
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
Subject was diagnosed with brain metastasis =21 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 a GPA Score of = 1.0;
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
- Secondary Outcome Measures
Name Time Method