Comparison of Veliparib and Whole Brain Radiation Therapy (WBRT) Versus Placebo and WBRT in Adults With Brain Metastases From Non-Small Cell Lung Cancer
Condition: Brain Metastases From Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Neoplasm Metastasis; Brain Neoplasms
Intervention: Veliparib; Placebo; Whole brain radiation therapy
Intervention description: Veliparib capsules for oral administration; Placebo to veliparib capsules for oral administration; 30.0 grays (Gy) of WBRT given in 10 daily fractions of 3.0 Gy each, excluding weekends and holidays
Intervention MeSH terms: Veliparib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 307.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the efficacy and safety of veliparib and
      whole brain radiation therapy in adults with brain metastases from non-small cell lung cancer
      (NSCLC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject must have cytologically or histologically confirmed non-small cell lung cancer

          -  Subject must have brain metastases demonstrated on a magnetic resonance imaging (MRI)
             brain scan.

          -  Subject must be eligible for treatment with WBRT

          -  Subject must have had adequate hematologic, renal, and hepatic function.

        Exclusion Criteria:

          -  Subject is diagnosed with brain metastases greater than 28 days prior to 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 less than or
             equal to 7 days prior to Day 1

          -  Subject has a Karnofsky Performance Score of less than 70

          -  Subject has significant dyspnea requiring supplemental oxygen therapy

          -  Subject has liver metastases (restaging is not required for known liver metastases)

          -  Subject has more than 2 sites (organ systems) of metastases from non-small cell lung
             cancer with the exception of intra-cranial sites of metastases from non-small cell
             lung cancer, thoracic sites of metastases from non-small cell lung cancer and bone
             metastases

          -  Subject has leptomeningeal metastases or subarachnoid spread of tumor

          -  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 poly-(ADP-ribose)-polymerase 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