A Phase I Trial Evaluating Concurrent Whole Brain Radiotherapy and Iniparib (BSI-201) in Multiple Non Operable Brain Metastases
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the Maximum Tolerated Dose (MTD)
The MTD is defined as the dose level at which the Dose Limiting Toxicity (DLT) is observed in more than 20% of patients. The DLT is defined as: Any treatment-related toxicity CTC v4.0 ≥ grade 3(CTC-AE v4.0 grading scale)
Until 12 week follow-up
Yes
David Azria, MD, PhD
Principal Investigator
CRLC Val d'Aurelle-Paul Lamarque
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
RAPIBE
NCT01551680
September 2012
March 2014
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