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Clinical Trials/EUCTR2011-003618-18-NO
EUCTR2011-003618-18-NO
Active, not recruiting
Phase 1

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

Abbott GmbH & Co. KG0 sites307 target enrollmentMay 29, 2012
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ConditionsBrain metastases from NSCLCMedDRA version: 14.1 Level: LLT Classification code 10006128 Term: Brain metastases System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Brain metastases from NSCLC
Sponsor
Abbott GmbH & Co. KG
Enrollment
307
Status
Active, not recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 29, 2012
End Date
January 22, 2015
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Subject must be \= 18 years of age;
  • •Subject must have cytologically or histologically confirmed NSCLC;
  • •Subject must have brain metastases as demonstrated on a MRI brain scan;
  • •Subject must be eligible for WBRT;
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 80
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range 250

Exclusion Criteria

  • •Subject was diagnosed with brain metastasis \=21 days prior to Treatment Day 1;
  • •Subject received any prior form of cranial radiation and/or neurosurgery for brain metastasis;
  • •Subject has a Karnofsky Performance Score (KPS) of \< 70;
  • •Subject has a GPA Score of \= 1\.0;
  • •Subject has significant dyspnea requiring supplemental oxygen therapy;
  • •Subject has liver metastases (restaging is not required for known liver metastasis);
  • •Subject has more than 2 sites (organ systems) of metastases from NSCLC with the exception of the following: intra\-cranial sites of metastasis from NSCLC, thoracic sites of metastasis from NSCLC, and bone metastasis;
  • •Subject has leptomeningeal metastases or subarachnoid spread of tumor as demonstrated on a baseline MRI brain scan;
  • •Subject's last dose of chemotherapy or investigational therapy was \= 7 days prior to Treatment Day 1;
  • •Subject has unresolved or unstable, serious toxicity from prior administration of another investigational drug and/or prior anti\-cancer treatment;

Outcomes

Primary Outcomes

Not specified

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