ACTRN12612001245886
Recruiting
Phase 2
A Randomized, Double-Blind, Phase 2, Dose-Ranging Study to Evaluate the Safety and Efficacy of Veliparib and Whole Brain Radiation Therapy Versus Placebo and Whole Brain Radiation Therapy in Subjects with Brain Metastases from Non-Small Cell Lung Cancer
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- AbbVie Pty Ltd
- Enrollment
- 300
- Status
- Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •\- 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:
Outcomes
Primary Outcomes
Not specified
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