Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 2 / Phase 3interventionalRules rewrite

Phase 2 / Phase 3: testing Temozolomide for Glioblastoma

Glioblastoma (GBM) adaptive, global, innovative learning environment (GBM AGILE) is an international, seamless Phase II/III response adaptive randomization platform trial designed to evaluate multiple therapies in newly diagnosed (ND) and recurrent GBM. All institutions are enrolling Newly Diagnosed participants.

Official registry: https://clinicaltrials.gov/study/NCT03970447 · Global Coalition for Adaptive Research · enrollment listed as 2,250

What this phase means

Phase 2/3: earlier tests looked promising enough to expand. This stage asks, in a larger group, whether the treatment really works and is safe enough to seek approval.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Temozolomide, Lomustine, or Regorafenib. The registry lists allocation as randomized. Glioblastoma (GBM) adaptive, global, innovative learning environment (GBM AGILE) is an international, seamless Phase II/III response adaptive randomization platform trial designed to evaluate multiple therapies in newly diagnosed (ND) and recurrent GBM.

They plan to enroll about 2,250 people at 63 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic, a procedure as part of the study plus check-ins.

Official title (unrewritten)

GBM AGILE: Global Adaptive Trial Master Protocol: An International, Seamless Phase II/III Response Adaptive Randomization Platform Trial Designed To Evaluate Multiple Regimens In Newly Diagnosed and Recurrent GBM

Interventions: Temozolomide, Lomustine, Regorafenib, Radiation, Paxalisib, VAL-083, VT1021, Troriluzole, ADI-PEG 20, AZD1390, Tinostamustine

Primary outcome (registry wording): Overall Survival (OS)

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • Karnofsky performance status ≥ 60% performed within a 14-day window prior to randomization
  • Availability of tumor tissue representative of GBM from definitive surgery or biopsy
  • Recurrent who can join:
  • Evidence of recurrent disease demonstrated by disease progression using slightly modified Response Assessment in Neuro-Oncology (RANO) criteria
  • Two scans to confirm progression are required: at least 1 scan at the time of progression and 1 scan prior to the time of progression
  • Karnofsky performance status ≥ 70% performed within a 14-day window prior to randomization
  • Availability of tumor tissue representative of GBM from initial definitive surgery and/or, recurrent surgery, if performed

Public study contact (from the registry)

Patient Information

310-598-3199

patientinfo@gcaresearch.org

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

63 listed

+ 21 sites outside the US on the same record

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FAQ about this NCT record

Is NCT03970447 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT03970447?

Phase 2 / Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT03970447?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary