- |||||||||| Inlyta (axitinib) / Pfizer
Trial completion, Trial completion date, Trial primary completion date, Combination therapy, Monotherapy: AxiGII: A Randomized Phase II Clinical Trial on the Efficacy of Axitinib as a Monotherapy or in Combination With Lomustine for the Treatment of Patients With Recurrent Glioblastoma (clinicaltrials.gov) - Jan 24, 2019 P2, N=56, Completed, Thus, concurrent chemotherapy appears as the dominant contributor to the severity of acute lymphopenia after RT in WHO grade II-III glioma patients, and duration of adjuvant chemotherapy appears as the key factor to prolonged lymphopenia. Active, not recruiting --> Completed | Trial completion date: Dec 2017 --> Dec 2018 | Trial primary completion date: Dec 2017 --> Aug 2018
- |||||||||| Avastin (bevacizumab) / Roche, Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Enrollment change, Trial completion date, Trial primary completion date, PD(L)-1 Biomarker: A Longitudinal Assessment of Tumor Evolution in Patients With Brain Cancer (clinicaltrials.gov) - Jan 24, 2019 P1, N=90, Recruiting, Active, not recruiting --> Completed | Trial completion date: Dec 2017 --> Dec 2018 | Trial primary completion date: Dec 2017 --> Aug 2018 N=45 --> 90 | Trial completion date: Feb 2020 --> Feb 2022 | Trial primary completion date: Feb 2019 --> Feb 2021
- |||||||||| lomustine / Generic mfg., temozolomide / Generic mfg., vincristine / Generic mfg.
Review, Journal: Chemotherapy Treatment and Trials in Low-Grade Gliomas. (Pubmed Central) - Jan 12, 2019 The addition of combination chemotherapy with procarbazine, lomustine, and vincristine confers survival advantage, as likely does temozolomide, but radiochemotherapy may not be appropriate for all patients owing to its toxicity profile. We review the approach to treatment in patients with low-grade gliomas with an emphasis on the clinical trials focusing on adjuvant chemotherapy in this population.
- |||||||||| galunisertib (LY2157299) / Eli Lilly
Trial completion date, Monotherapy: A Study in Recurrent Glioblastoma (GB) (clinicaltrials.gov) - Nov 21, 2018 P2, N=180, Active, not recruiting, Trial completion date: Oct 2018 --> May 2019 Trial completion date: Dec 2018 --> Dec 2019
- |||||||||| Avastin (bevacizumab) / Roche
Journal, IO biomarker: High-grade Gliomas. (Pubmed Central) - Aug 10, 2018 Despite aggressive treatment, these tumors progress, and overall outcomes have not changed much in the past decade. However, our understanding of the disease is improving, and newer therapies appear promising.
- |||||||||| lomustine / Generic mfg., temozolomide / Generic mfg., vincristine / Generic mfg.
Journal: Low-grade Gliomas. (Pubmed Central) - Aug 10, 2018 While the combination of radiation and PCV provides the best proven overall survival with low-grade gliomas, important questions remain. These include whether the better-tolerated temozolomide is as effective as PCV in conjunction with radiation therapy and whether the use of initial chemotherapy as a strategy to defer the potential delayed cognitive toxicity associated with radiation will yield acceptable survival results with a favorable toxicity profile.
- |||||||||| Biomarker, Clinical, P2 data, Journal, Monotherapy: Diffusion MRI phenotypes predict overall survival benefitfrom anti-VEGF monotherapy in recurrent glioblastoma:Converging evidence from phase II trials. (Pubmed Central) - Jul 20, 2018
P2 These findings were validated using a separate trial comparing bevacizumab with lomustine.Experimental Design: Patients with recurrent GBM and diffusion MRI from the monotherapy arms of 5 separate phase II clinical trials were included: (i) cediranib (NCT00035656); (ii) bevacizumab (BRAIN Trial, AVF3708g; NCT00345163); (iii) cabozantinib (XL184-201; NCT00704288); (iv) aflibercept (VEGF Trap; NCT00369590); and (v) bevacizumab or lomustine (BELOB; NTR1929)...An ADCL threshold of 1.24 um(2)/ms produced the largest OS differences between patients (HR~0.5) and patients with an ADCL>1.24 um(2)/ms had close to double the OS in all anti-VEGF therapeutic scenarios tested. Training and validation data confirmed baseline ADCL was an independent predictive biomarker for OS in anti-VEGF therapies, but not lomustine, after accounting for age and baseline enhancing tumor volume. Pre-treatment diffusion MRI is a predictive imaging biomarker for OS in patients with recurrent GBM treated with anti-VEGF monotherapy at first or second relapse.
- |||||||||| Avastin (bevacizumab) / Roche
Trial completion date: EORTC 26101: Bevacizumab and Lomustine for Recurrent GBM (clinicaltrials.gov) - Mar 3, 2018 P3, N=433, Active, not recruiting, Active, not recruiting --> Completed | Trial completion date: Aug 2020 --> May 2018 Trial completion date: Oct 2017 --> Aug 2018
- |||||||||| erteberel (LY500307) / Eli Lilly
Journal: Selective Estrogen Receptor β Agonist LY500307 as a Novel Therapeutic Agent for Glioblastoma. (Pubmed Central) - Jan 24, 2018 LY500307 treatment significantly reduced the in vivo tumor growth and promoted apoptosis of GBM tumors in an orthotopic model and improved the overall survival of tumor-bearing mice in the GL26 syngeneic glioma model. Our results demonstrate that LY500307 has potential as a therapeutic agent for GBM.
- |||||||||| Stivarga (regorafenib) / Bayer
Enrollment closed, Trial primary completion date: REGOMA: Regorafenib in Relapsed Glioblastoma (clinicaltrials.gov) - Oct 9, 2017 P2, N=119, Active, not recruiting, N=187 --> 380 | Trial primary completion date: Nov 2017 --> Dec 2019 Recruiting --> Active, not recruiting | Trial primary completion date: Oct 2017 --> Jul 2017
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