Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
210

Summary

Conditions
  • Glioblastoma Multiforme
  • Primary Glioblastoma
Type
Interventional
Phase
Phase 2Phase 3
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This is a randomized, double-blind, placebo-controlled, 2 parallel arms (1:1), adjuvant trial to assess the efficacy of 2-OHOA vs placebo in patients with ndGBM. The 2 arms are: Arm A: SoC + placebo for 2-OHOA; Arm B: SoC + 12g/day of 2-OHOA Treatment consists of 3 phases: Chemoradiotherapy (6 to 7 weeks) RT in daily fractions of 2Gy, 5 days per week (60Gy) TMZ 75mg/m2 daily (maximum of 49 days) Placebo or 2-OHOA for 4 weeks (from week 3 to week 6, both inclusive) -Washout period (4 weeks) Maintenance (4-week cycles, maximum of 6 cycles) Placebo/2-OHOA daily in the first 3 weeks of each cycle, followed by 7 days washout TMZ 150-200mg/m2 daily in the first 5 days of each cycle Monotherapy: 4-week cycles until disease progression, unacceptable toxicity or lack of clinical benefit Placebo/2-OHOA daily in the first 3 weeks of each cycle followed by 7 days washout Masking: Triple (Participant, Care Provider, Investigator)Masking Description: At the Screening Visit, the IRT will assign a unique number to the subject. The site will use the IRT to receive drug kit numbers and a unique randomization number. Subjects will be randomized to Arm A or B in a 1:1 ratio. Drug kit numbers and treatment content will be assigned according to a list generated before the start of the study. At interim, the IRT vendor will transfer the list of attribution to the iSCs. After the final lock, the list of attribution will be transmitted to the company involved in analysis. The IRT vendor will be in charge of the stock management/logistics in each site and shipments. Upon receipt of study drug, the study site will acknowledge receipt in the IRT system. The investigators, the study site personnel and subject will remain blinded to throughout the course of the study. The IRT will provide access to for a subject in case of medical emergency. If sponsor/clinical team should break the blind, the reason will be documented on the eCRF.Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 75 years
Gender
Both males and females

Description

This is a randomized, double-blind, placebo-controlled, 2 parallel arms (1:1 ratio), adjuvant trial to assess the efficacy of 2-hydroxyoleic acid (2-OHOA) versus placebo in patients with newly diagnosed, IDH wildtype, GBM. In all arms, patients will receive the SoC and will be randomized to receive ...

This is a randomized, double-blind, placebo-controlled, 2 parallel arms (1:1 ratio), adjuvant trial to assess the efficacy of 2-hydroxyoleic acid (2-OHOA) versus placebo in patients with newly diagnosed, IDH wildtype, GBM. In all arms, patients will receive the SoC and will be randomized to receive either placebo or 2-OHOA dose. The primary endpoint of the study is PFS. The study is planned to initially enrol 180 patients and collect a total of 124 PFS events. After 62 events for PFS are observed, a formal interim analysis will be performed and the data reviewed by an Independent Data Monitoring Committee (IDMC) or may be activated by the IDMC 12 months after the inclusion of the last patient if follow up is sufficient to identify an overall PFS or OS significant deviation from the literature. After reviewing the interim results, the iDMC will make recommendations regarding: the sample size and the continuation of the trial overall. At interim analysis, if molecular data permit to identify a subpopulation of patients who respond better to the combination treatment, this signature will be applied to the patients entering in the second stage of the trial and the treatment effect will be estimated in the corresponding subgroup (Adaptive signaturedesign according to Freidlin and Simon, Clin Cancer Res 2005). Further, the sample size and events will be re-estimated to ensure that the statistical power is maintained given the estimated treatment effect at interim analysis. The events/sample size increase will be based on the considerations of the success probability in the full population and the subpopulation. For that purpose, based on the conditional power, the interim results will be classified into the following zones: favourable, unfavourable or promising with a planned enrolment of 60 additional patients or 114 additional patients. If the interim results fall in the promising zone, then it is planned to increase the total number of events both for PFS and OS by up to 50%, with up to 186 events for PFS and up to 186 events for OS. The total sample size will also be increased to up to 234 patients to ensure the desired number of events within a realistic time. If the interim results are favourable or unfavourable, the study size will remain as initially planned with 124 events for PFS and for OS, collected from 180 patients. Depending on prevalence and strength of treatment effect in the subpopulation, it may also be decided to enlarge the subpopulation beyond those to be expected by prevalence in the second cohort, up to a maximum of 275 patients.

Tracking Information

NCT #
NCT04250922
Collaborators
  • Specialized Medical Services (SMS)-Oncology BV
  • Northern Institute for Cancer Research, Newcastle
  • Theradis pharma
  • LIPODOM THERAPEUTICS
Investigators
Not Provided
About Us
Innovation
Privacy
Terms
Copyright
Get Well Soon © Copyright 2024