Brain metastases from NSCLC MedDRA version: 14.1 Level: LLT Classification code 10006128 Term: Brain metastases System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Veliparib 50 mg
Product Code: ABT-888
Pharmaceutical Form: Capsule
INN or Proposed INN: Veliparib
Current Sponsor code: AB
Sponsors
Abbott GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion 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
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; 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 metastasis 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 PARP inhibitor as an investigational agent; Subject has clinically significant and uncontrolled major medical condition(s)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess whether the addition of Veliparib when given during whole brain radiation therapy (WBRT) improves Overall Survival (OS) for subjects with brain metastases from Non-small Cell Lung Cancer (NSCLC).;Secondary Objective: To assess Safety, Response Rate of Brain Metastases at 4 months, Time to Intracranial Progression (Radiographic), and Time to Clinical Brain Metastasis Progression. Also to evaluate whether addition of twice daily oral Veliparib during WBRT delays deterioration of neurological symptoms, delays functional decline, and improves subject quality of life.;Primary end point(s): The primary endpoint for this study is Overall Survival;Timepoint(s) of evaluation of this end point: Overall Survival for a given subject will be defined as the number of days from the date the subject was randomized to the date of the subject's death | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Best Tumor Response Rate will be defined as the proportion of subjects with a complete or partial response determined by the central imaging vendor based on the bi-dimensional criteria; Time to Intracranial Progression (radiographic) will be defined as the number of days from the date the subject was randomized to the date the subject experienced an event of radiographic progression (intracranial) determined by the central imaging vendor; Time to Clinical Brain Metastasis progression will be defined as the number of days from the date of randomization to the date of earliest neurological deterioration (signs and symptoms) as determined by the Event Review Board ; Timepoint(s) of evaluation of this end point: Clinical Brain Metastasis progression defined as the number of days from the date of randomization to the date of earliest metastasis progression. All metastasis progression is included regardless of whether the subject has discontinued taking the drug. If no metastasis progression, the data will be censored at the date of last neurological assessments. If the subject has no post baseline neurological assessments, then the subject will be censored at the date of randomization Overall Survival:Time to death is defined as the number of days from the date of randomization to the subject's death. All events of death are included, regardless of if the subject has discontinued taking the drug. If a subject has not died, then the data will be censored at subject's last known alive date. | — |
Countries
Argentina, Australia, Belgium, Brazil, Canada, Chile, Czech Republic, Egypt, Finland, Hungary, Korea, Republic of, Norway, Portugal, Puerto Rico, Russian Federation, Spain, Taiwan, Ukraine, United States
Contacts
Public ContactEU Clinical Trials Helpdesk
Abbott Laboratories
Outcome results
None listed