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Clinical Trial 19385
Interventions:AZD2171 (Cediranib); Avastin (Bevacizumab); Bevacizumab; Cediranib (Recentin); FMISO; Olaparib (Lynparza)
Study Type: Treatment
Phase of Study: Phase II
- Solmaz Sahebjam
A Randomized Phase 2 trial of Cediranib and Olaparib Compared to Bevacizumab in Patients with Recurrent Glioblastoma who have not Received Prior VEGF Therapy
The main purpose of this study is to compare the safety and effects of the study drugs called cediranib and olaparib.
Primary Objectives: 1. To compare the anitumor activity of cediranib/olaparib versus reference bevacizumab monotherapy, as measured by progression-free survival at 6 months (PF6), in patients with recurrent GBM. 1.2 Secondary Objectives: 1. To compare overall survival (OS), and objective response (ORR) in patients with recurrent GBM treated with cediranib/olaparib versus bevacizumab. 2. To assess the safety of the combination of olaparib and cediranib in patients with recurrent GBM. 3. To evaluate the association of blood based biomarkers involved with angiogenesis using the Biomarker Review Committee-approved Plasma Angiome Panel (bFGF, Ang-1, Ang-2, Tie-2, SDF1-alpha, Collagen IV, PlGF, sVEGFR1, sVEGFR2, VEGF, Il-1beta, Il-6, Il-8, TNF-alpha, CAIX) with the clinical activity of cediranib/olaparib. 4. To evaluate the association of tissue biomarkers involved with DNA repair using the Biomarker Review Committee-approved BROCA panel with the clinical activity of cediranib/olaparib. 5. To identify genomic alteration by whole exome sequencing in GBM tumor specimens that correlate with the clinical activity of cediranib/olaparib. 6. To evaluate the association of MRI and PET imaging parameters ( tumor perfusion and oxygenation, brain tumor cellularity) with the biological response of cediranib/olaparib.