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)

This study is currently recruiting participants.
Verified April 2014 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01657799
First received: August 2, 2012
Last updated: April 4, 2014
Last verified: April 2014
  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:


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 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 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 132 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: April 4, 2014
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
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines
France: Agence Nationale de Sécurité du Médicament et des produits de santé

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 April 16, 2014