Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06630260 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

5G-RUBY: Avutometinib and Defactinib in Malignant Brain Tumours

Study acronym: 5G-RUBY
StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Site details revised at 1 of 3 sitesv5
  2. Start date changed from estimate of Nov 4, 2024 to Nov 15, 2024
    • Eligibility criteria expanded, about 2 words
    v4
  3. Site details revised at 1 of 3 sitesv3
  4. Start date: Oct 1, 2024 to Nov 4, 2024v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this clinical trial is to evaluate the safety and tolerability of avutometinib and defactinib and to determine the preliminary antitumour activity of avutometinib and defactinib administered at the recommended Phase 2 dose (RP2D). In the Phase 1b of this study parallel biomarker defined arms will be opened, initially in the relapsed GMB setting, enrolling 12 patients onto each arm. These patients will be treated with avutometinib and defactinib double therapy. Avutometinib will be administered orally at 3.2mg twice a week (e.g., on Monday / Thursday or Tuesday / Friday) with or without a meal. The total weekly dose of avutometinib is 6.4mg. Defactinib will be administered orally, at 200mg, twice a day within 30 min after a meal. The total daily dose of defactinib is 400mg. Once a treatment in any biomarker arm has met the "GO" decision (≥3 successes/12 patients) for relapsed GBM in Phase 1b, that arm can progress to Phase 2. The primary objective of Phase 2 is to determine the antitumour activity of investigational agents administered at the RP2D in patients with molecularly defined malignant brain tumours.
Trial Details
NCT Number NCT06630260
Lead Sponsor Institute of Cancer Research, United Kingdom
Collaborators: Minderoo Foundation, Verastem, Inc., Royal Marsden NHS Foundation Trust, Cambridge University Hospitals NHS Foundation Trust, Cancer Research UK, University of Cambridge
Conditions
(from sponsor)		 Glioblastoma Multiforme (GBM), Glioblastoma Multiform (Grade IV Astrocytoma), Diffuse Hemispheric Glioma, H3 G34-Mutant, Malignant Primary Gliomas
Related terms Glioblastoma
Enrollment 182 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov