Phase 2 Study of Sorafenib, Valproic Acid, and Sildenafil in the Treatment of Recurrent High-Grade Glioma
Sponsor study identifier
Secondary identifiers
interventional
47
1 country
1
Study Start
April 11, 2013
Actual (reported)Primary Completion
August 27, 2020
Actual (reported)Study Completion
May 12, 2023
Actual (reported)The purpose of this research study is to test the safety, tolerability, and effectiveness of the combination of three drugs, sorafenib (Nexavar®), valproic acid (Depakote®), and sildenafil (Viagra®), when used to treat high-grade glioma, a type of brain tumor.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 12, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 20, 2013
Actual (reported)March 25, 2013
Actual (reported)April 11, 2013
Actual (reported)August 27, 2020
Actual (reported)October 28, 2021
Actual (reported)May 12, 2023
Actual (reported)Number of Participants With 6-Month Progression Free Survival (PFS)
Number of patients evaluable for response, regardless of tumor platelet derived growth factor receptor (PDGFR) status, with 6- month PFS defined as the time from the first day a patient receives study treatment until time of progression per response assessment in neuro-oncology (RANO) or Macdonald criteria or death, whichever occurs first.
Up to 6 months
Number of Participants Whose Tumors Express PDGFRa With and Without 6-Month PFS.
Up to 6 months
Number of Participants With Best Response of CR Plus Number of Participants With Best Response of PR.
From the first day of study treatment until best response or off study, up to 4 years
* Sorafenib 400 mg orally twice a day; * Valproic acid (to levels ≥ Lower Level of Normal (LLN) orally twice a day; * Sildenafil 50 mg orally twice a day A cycle consists of 4 weeks. \*The first 6 patients evaluable for qualifying toxicity assessment will be treated as a safety lead-in; enrollment will be gated (the first 3 evaluable patients must complete 4 weeks of the combination therapy before the next 3 patients start combination treatment on protocol)
Given by mouth
Given by mouth
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298, United States
Lang F, Liu Y, Chou FJ, Yang C. Genotoxic therapy and resistance mechanism in gliomas. Pharmacol Ther. 2021 Dec;228:107922. doi: 10.1016/j.pharmthera.2021.107922. Epub 2021 Jun 23.
Andrew Poklepovic, MD
Massey Cancer Center
47 participants (actual enrollment reported by the registry).
First Submitted
March 20, 2013
First Posted
March 25, 2013
Study Start
April 11, 2013
Actual (reported)Primary Completion
18F-DOPA-PET/MRI Scan in Imaging Elderly Patients With Newly Diagnosed Grade IV Malignant Glioma or Glioblastoma During Planning for a Short Course of Proton Beam Radiation Therapy
Number of Participants Whose Tumors Express PDGFRa With Best Response of CR Plus Number of Participants Whose Tumor Expresses PDGFRa With Best Response of PR.
From initiation of study treatment to time of best response or off-study (up to 4 years)
Number of Participants With 12-Month Overall Survival (OS)
12 months
Number of Participants Whose Tumors Express PDGFRa With and Without 12-Month OS.
Up to 12 months
Given by mouth
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
August 27, 2020
Actual (reported)Study Completion
May 12, 2023
Actual (reported)Last Updated
July 17, 2024
Results First Posted
October 28, 2021
Record last verified: 2024-06
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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