None listed
Conditions
Brief summary
This study looks at: 1. The safety of two different dose levels of Veliparib when it is given together with WBRT 2. To determine if participants benefit more with veliparib and WBRT compared to placebo (a substance that looks like the real medication but has no active ingredients) and WBRT. Who is it for: Patients with brain metastases from non-small cell lung cancer. Trial details: Participants will take Veliparib/Placebo orally twice per day, every day while receiving WBRT. Participants will also dose the day following the last day of WBRT. Participants will then have monthly visits for 9 months, followed by visits every 3 months for up to 2 years.
Interventions
Arm 1 - 200mg Veliparib twice daily (BID) + Whole Brain Radiation Therapy (WBRT)
Arm 2 - 50mg Veliparib BID + WBRT
Arm 3 - Placebo BID + WBRT
All Veliparib and Placebo doses are administered orally. WBRT for all 3 arms will be a total of 30.0 Gray (Gy) given in 10 daily fractions of 3.0 Gy each excluding weekends and holidays.
Veliparib/Placebo treatment will begin on the first day of WBRT. The final dose of Veliparib/Placebo will occur the day following the last day of treatment with WBRT.
Sponsors
AbbVie Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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: 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
Outcome results
None listed