A Clinical Study Conducted in Multiple Centers Comparing Veliparib and Whole Brain Radiation Therapy (WBRT) Versus Placebo and WBRT in Subjects With Brain Metastases From Non Small Cell Lung Cancer (NSCLC)
- Conditions
- Brain Metastases from Non-Small Cell Lung CancerCancer - BrainCancer - Lung - Non small cell
- Registration Number
- ACTRN12612001245886
- Lead Sponsor
- AbbVie Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 300
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 treatment with WBRT
- Subject must have adequate hematologic, renal, and hepatic function
- Women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation and for a minimum of 90 days
following completion of therapy.
- Subject must be able to take oral medication
- Subject is capable of understanding and complying with parameters as outlined in the protocol and able to sign and date the informed consent
- Subject is diagnosed with brain metastases = 21 days prior to Treatment 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 = 7 days prior to Treatment Day 1. Subjects may continue to receive Bisphosphonates,
steroids, such as inhaled steroids for asthma, topical steroids, or replacement/stress corticosteroids, and medroxyprogesterone during the study if started prior to
treatment with veliparib/placebo and WBRT
- Subject has a Karnofsky Performance Score (KPS) of < 70
- Subject has a GPA Score of = 1.0
- Subject has clinically significant dyspnea requiring supplemental oxygen therapy
- Subject has liver metastases
- Subject has more than 2 sites (organ systems) of metastases from NSCLC with the exception of the following:
Intra-cranial sites of metastases from NSCLC; Thoracic sites of metastases from NSCLC; and Bone metastases
- Subject has leptomeningeal metastases or subarachnoid spread of tumor as demonstrated on a MRI brain scan
- 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 PARP 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method