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A Randomized, Double-blind, Placebo-controlled Adjuvant Trial in Newly Diagnosed Primary Glioblastoma Subjects to Assess the Efficacy and Safety of LAM561 in Combination With Radiotherapy and Temozolomide Standard of Care Treatment.

Trial Profile

A Randomized, Double-blind, Placebo-controlled Adjuvant Trial in Newly Diagnosed Primary Glioblastoma Subjects to Assess the Efficacy and Safety of LAM561 in Combination With Radiotherapy and Temozolomide Standard of Care Treatment.

Status: Active, no longer recruiting
Phase of Trial: Phase II/III

Latest Information Update: 06 Mar 2025

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At a glance

  • Drugs 2-hydroxyoleic acid (Primary) ; Temozolomide (Primary)
  • Indications Glioblastoma
  • Focus Registrational; Therapeutic Use
  • Acronyms CLINGLIO
  • Sponsors Laminar Pharmaceuticals

Most Recent Events

  • 06 Mar 2025 According to a Laminar Pharmaceuticals media release, company announced that the Independent Data Monitoring Committee (IDMC) after evaluating the interim clinical results of the CLINGLIO clinical trial, has recommended that the trial should "continue without modifications.
  • 11 Jun 2024 According to a Laminar Pharmaceuticals media release, the trial is expected to reach the trigger event for interim analysis in July 2024, which would provide an unblinded readout the last quarter of this year. These unblinded results will be submitted for EMA evaluation for Conditional Marketing Authorization in early 2025, and the trial will continue until final analysis of survival in 2026.
  • 11 Jun 2024 According to a Laminar Pharmaceuticals media release, the recruitment for this study has been completed and 140 patients have been recruited at sites in Spain, Italy, France and United Kingdom. The open readout of the trial is expected by late 2024.

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