A Clinical Study Conducted in Multiple Centers Comparing Veliparib and Whole Brain Radiation Therapy (WBRT) Versus Placebo and WBRT in Subjects With Brain Metastases From Non Small Cell Lung Cancer (NSCLC) - Full Text View

Purpose

The primary objective of this study is to evaluate the Overall Survival, Best Tumor Response Rate, Time to Intracranial Progression (radiographic), Time to Clinical Brain Metastasis Progression, safety, and tolerability of veliparib and Whole Brain Radiation Therapy in subjects with brain metastases from Non Small Cell Lung Cancer

Condition	Intervention	Phase
Brain Metastases From Non-small Cell Lung Cancer	Drug: Veliparib Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

U.S. FDA Resources

Further study details as provided by AbbVie:

Primary Outcome Measures:

Overall Survival [ Time Frame: Survival assesments are performed for up to 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Best Tumor Response Rate [ Time Frame: Radiographic evaluation is performed up to 36 months or until documented radiographic brain metastases progression or date of death from any cause, whichever comes first ] [ Designated as safety issue: No ]
Time to Intracranial Progression (radiographic) [ Time Frame: Radiographic evaluation will be performed for up to 24 months or until documented radiographic brain metastases progression or date of death from any cause, whichever comes first ] [ Designated as safety issue: No ]
Time to Clinical Brain Metastasis progression [ Time Frame: Neurological assessments will be performed up to 24 months or until documented clinical brain metastases progression or date of death from any cause, whichever comes first ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	October 2012
Estimated Study Completion Date:	November 2014
Estimated Primary Completion Date:	November 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Group 1 High dose veliparib administered concomitantly with whole brain radiation therapy (WBRT).	Drug: Veliparib High dose veliparib given continuously throughout the entire course of WBRT. One treatment of 3.0 Gy WBRT will be given daily 5 days per week (10 fractions) for a total of 30.0 Gy.
Experimental: Group 2 Low dose veliparib administered concomitantly with WBRT.	Drug: Veliparib Low dose veliparib given continuously throughout the entire course of WBRT. One treatment of 3.0 Gy WBRT will be given daily 5 days per week (10 fractions) for a total of 30.0 Gy.
Placebo Comparator: Group 3 Placebo administered concomitantly with WBRT.	Drug: Placebo Placebo given continuously throughout the entire course of WBRT. One treatment of 3.0 Gy WBRT will be given daily 5 days per week (10 fractions) for a total of 30.0 Gy.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject must be greater than or equal to 18 years of age
Subject must have cytologically or histologically confirmed non-small cell lung cancer
Subject must have brain metastases demonstrated on a MRI brain scan
Subject must be eligible for WBRT

Exclusion Criteria:

Subject is diagnosed with brain metastases greater than 28 days prior to treatment
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 treatment
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01657799

Contacts

Contact: Kyle Holen, MD	847-937-3484	kyle.holen@abbvie.com
Contact: Tina Waskiewicz, BS	847-935-5595	tina.waskiewicz@abbvie.com

Show 82 Study Locations

Sponsors and Collaborators

AbbVie (prior sponsor, Abbott)

Investigators

Study Director:

Vincent Giranda, MD

AbbVie

More Information

No publications provided

Responsible Party:	AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:	NCT01657799 History of Changes
Other Study ID Numbers:	M10-897, 2011-003618-18
Study First Received:	August 2, 2012
Last Updated:	May 1, 2013
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration Belgium: Federal Agency for Medicinal Products and Health Products Brazil: Ministry of Health Canada: Health Canada Chile: Instituto de Salud Publica de Chile Czech Republic: State Institute for Drug Control Egypt: Ministry of Health, Drug Policy and Planning Center Finland: Ministry of Social Affairs and Health Korea: Food and Drug Administration Norway: Norwegian Medicines Agency Russia: Ministry of Health of the Russian Federation Spain: Agencia Española de Medicamentos y Productos Sanitarios Taiwan : Food and Drug Administration Ukraine: Ministry of Health United States: Food and Drug Administration Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasm Metastasis
Brain Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms

Lung Diseases
Respiratory Tract Diseases
Neoplastic Processes
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 23, 2013