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Comparison of Veliparib and Whole Brain Radiation Therapy (WBRT) Versus Placebo and WBRT in Adults With Brain Metastases From Non-Small Cell Lung Cancer | Clinical Trials | Clareo Health

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Comparison of Veliparib and Whole Brain Radiation Therapy (WBRT) Versus Placebo and WBRT in Adults With Brain Metastases From Non-Small Cell Lung Cancer

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

NCT01657799•AbbVie (prior sponsor, Abbott)

View on ClinicalTrials.gov

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

Age

18 - 99 years

Sex

ALL

Healthy Volunteers

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
+4 more criteria

Key Dates

Start Date

October 19, 2012

Primary Completion Date

January 22, 2015

Completion Date

January 22, 2015

Last Updated

June 6, 2018

Enrollment

307

ACTUAL participants

Conditions

Brain Metastases From Non-small Cell Lung Cancer

Interventions

Veliparib

DRUG

Placebo

DRUG

Whole brain radiation therapy

RADIATION

Durvalumab (MEDI4736) and Radiosurgery (fSRT Vs. PULSAR) for the Treatment of Non-Small Cell Lung Cancer Brain Metastases

NCT04889066

Brain Metastases from Non-small Cell Lung Cancer

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 6, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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