Clinical trial NCT01657799: Comparison of Veliparib and Whole Brain Radiation Therapy (WBRT) Versus Placebo and WBRT in Adults With Brain Metastases From Non-Small Cell Lung Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Brain Metastases From Non-small Cell Lung Cancer
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2012-08-06
Enrollment: 307
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Overall Survival
timeFrame: From randomization up to 36 months
Secondary outcomes:
measure: Best Tumor Response Rate
timeFrame: From randomization up to 24 months
measure: Time to Intracranial Progression (Radiographic)
timeFrame: From randomization up to 24 months
measure: Time to Clinical Brain Metastasis Progression
timeFrame: From randomization up to 24 months
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: Vincent Giranda, MD
role: STUDY_DIRECTOR
References:
citation: Chabot P, Hsia TC, Ryu JS, Gorbunova V, Belda-Iniesta C, Ball D, Kio E, Mehta M, Papp K, Qin Q, Qian J, Holen KD, Giranda V, Suh JH. Veliparib in combination with whole-brain radiation therapy for patients with brain metastases from non-small cell lung cancer: results of a randomized, global, placebo-controlled study. J Neurooncol. 2017 Jan;131(1):105-115. doi: 10.1007/s11060-016-2275-x. Epub 2016 Sep 21.