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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Brain Metastases From Non-small Cell Lung Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall Survival

Outcome Time Frame:

Survival assesments are performed for up to 36 months

Safety Issue:

No

Principal Investigator

Vincent Giranda, MD

Investigator Role:

Study Director

Investigator Affiliation:

AbbVie

Authority:

Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:

M10-897

NCT ID:

NCT01657799

Start Date:

October 2012

Completion Date:

November 2014

Related Keywords:

  • Brain Metastases From Non-small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Neoplasm Metastasis
  • Brain Neoplasms

Name

Location

Site Reference ID/Investigator# 68494Goshen, Indiana  46526
Site Reference ID/Investigator# 68311Farmington Hills, Michigan  48334
Site Reference ID/Investigator# 68495Birmingham, Alabama  35233
Site Reference ID/Investigator# 65828Chandler, Arizona  85224
Site Reference ID/Investigator# 66052Tucson, Arizona  85724
Site Reference ID/Investigator# 92618Tucson, Arizona  85704
Site Reference ID/Investigator# 92623Tucson, Arizona  85704
Site Reference ID/Investigator# 65832Los Angeles, California  90033
Site Reference ID/Investigator# 96255Los Angeles, California  90033
Site Reference ID/Investigator# 72793San Francisco, California  94115-1705
Site Reference ID/Investigator# 92616Lone Tree, Colorado  80124
Site Reference ID/Investigator# 68161Deerfield Beach, Florida  33442
Site Reference ID/Investigator# 66025Chicago, Illinois  60611
Site Reference ID/Investigator# 81813New Albany, Indiana  47150
Site Reference ID/Investigator# 65830Detroit, Michigan  48202
Site Reference ID/Investigator# 84773Lansing, Michigan  48912
Site Reference ID/Investigator# 80473Hackensack, New Jersey  07601
Site Reference ID/Investigator# 68317Manhasset, New York  11030
Site Reference ID/Investigator# 69291Philadelphia, Pennsylvania  19141
Site Reference ID/Investigator# 70553Philadelphia, Pennsylvania  19104
Site Reference ID/Investigator# 73993Philadelphia, Pennsylvania  19124
Site Reference ID/Investigator# 92614Arlington, Texas  76014
Site Reference ID/Investigator# 66703Dallas, Texas  75390
Site Reference ID/Investigator# 92615Denton, Texas  76210