Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06359379
Status:
RECRUITING
Last Update Posted:
2024-04-11
First Post:
2024-03-24
Brief Title:
Ropidoxuridine as a Radiosensitizer in Newly Diagnosed IDH-Wildtype Glioblastoma With Unmethylated MGMT Promoter
Sponsor:
Shuttle Pharmaceuticals Inc
Organization:
Shuttle Pharmaceuticals Inc
Study Overview
Official Title:
Phase 2 Study of Ropidoxuridine as a Radiation Sensitizing Agent During Radiotherapy in Patients With Newly Diagnosed IDH-Wildtype Glioblastoma With Unmethylated MGMT Promoter
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a randomized open-label phase 2 study evaluating the safety and efficacy of oral ropidoxuridine as a radiation-sensitizing agent in patients with newly diagnosed wild-type isocitrate dehydrogenase glioblastoma with an unmethylated O6-methylguanine-DNA methyltransferase promoter undergoing standard 60 Gy radiotherapy
Detailed Description:
This is a randomized open-label phase 2 study to assess the safety and efficacy of oral ropidoxuridine as a radiation sensitizing agent in patients with newly diagnosed wildtype isocitrate dehydrogenase glioblastoma with unmethylated O6-methylguanine-DNA methyltransferase promoter receiving standard 60 Gy radiotherapy
In the dose optimization phase a group of 40 patients will be evenly divided with a 11 randomization to receive ropidoxuridine for a duration of 7 weeks They will be administered daily ropidoxuridine at two dose levels either 960 mg or 1200 mg This administration will occur 5 days a week from Monday to Friday Treatment with ropidoxuridine will start one week before radiotherapy induction period and continue concomitantly with 60 Gy standard radiotherapy fractionated in 2 Gy daily doses Monday through Friday weeks 2 to 7 treatment period followed by a 4-week rest period Following completion of this 11-week active study period maintenance therapy including temozolomide tumor treating field device Optune or other available treatment modalities may be initiated at the discretion of the Investigator
Analysis of the pharmacokinetic safety and tolerability data for the two cohorts will determine the optimal dose of ropidoxuridine to be administered to the next cohort of 14 patients for determination of efficacy compared to historical controls
A magnetic resonance imaging MRI will be performed at the end of the active study period Week 11 This MRI should not be used for disease assessment due to increased contrast enhancement in the acute radiation reaction phase unless there is evidence of progression outside the radiotherapy fields Radiographic disease assessment will be performed in accordance with community standard of care guidelines every 3 months until disease progression After the confirmed disease progression survival monitoring follow-ups will occur every three months
In the dose optimization phase a group of 40 patients will be evenly divided with a 11 randomization to receive ropidoxuridine for a duration of 7 weeks They will be administered daily ropidoxuridine at two dose levels either 960 mg or 1200 mg This administration will occur 5 days a week from Monday to Friday Treatment with ropidoxuridine will start one week before radiotherapy induction period and continue concomitantly with 60 Gy standard radiotherapy fractionated in 2 Gy daily doses Monday through Friday weeks 2 to 7 treatment period followed by a 4-week rest period Following completion of this 11-week active study period maintenance therapy including temozolomide tumor treating field device Optune or other available treatment modalities may be initiated at the discretion of the Investigator
Analysis of the pharmacokinetic safety and tolerability data for the two cohorts will determine the optimal dose of ropidoxuridine to be administered to the next cohort of 14 patients for determination of efficacy compared to historical controls
A magnetic resonance imaging MRI will be performed at the end of the active study period Week 11 This MRI should not be used for disease assessment due to increased contrast enhancement in the acute radiation reaction phase unless there is evidence of progression outside the radiotherapy fields Radiographic disease assessment will be performed in accordance with community standard of care guidelines every 3 months until disease progression After the confirmed disease progression survival monitoring follow-ups will occur every three months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None