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Phase I Trial of Defactinib and VS-6766.

Study acronym: FRAME
StatusActive, Not Recruiting
PhasePhase 1
Started
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Record History

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  1. Study completion date: Oct 31, 2023 to Oct 31, 2026v10
  2. Primary completion date changed from estimate of Sep 30, 2022 to Apr 30, 2023v9 Show 5 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 110 to confirmed 87
    • Study completion date: Mar 30, 2023 to Oct 31, 2023
    • Site details revised at 5 of 5 sites
    • Study title revised
  3. Primary completion date: Jul 12, 2021 to Sep 30, 2022v8 Show 11 more changesShow less
    • Primary endpoints revised (2)
    • Enrollment target: 80 to 110
    • Study sites: 3 to 5
    • Study completion date: Jul 12, 2021 to Mar 30, 2023
    • Interventions: RO5126766 (Drug), VS-6063 (Drug) to Defactinib (Drug), VS-6766 (Drug)
    • Eligibility criteria expanded, about 125 words
    • Secondary endpoints revised (3)
    • Study description expanded, about 61 words
    • Collaborators: 2 to 1
    • Study title revised
    • Study arms: 5 to 8
  4. Primary and study completion dates: Dec 12, 2020 to Jul 12, 2021
    • Study sites: 2 to 3
    v7
  5. Trial status: Active, Not Recruiting to Recruiting
    • Site details revised at 2 of 2 sites
    v6
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  1. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 2 of 2 sites
    v5
  2. Re-verified, no change to tracked fieldsv4
  3. Site contacts updated at 2 of 2 sitesv3
  4. Enrollment target: 50 to 80v2 Show 4 more changesShow less
    • Eligibility criteria expanded, about 58 words
    • Study description expanded, about 13 words
    • Site contacts updated at 1 of 2 sites
    • Study arms: 3 to 5
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a multi-centre, investigator-initiated, dose escalation, Phase I trial of the combination of the FAK inhibitor, Defactinib (VS-6063), and the dual RAF/MEK inhibitor, VS-6766 (RO5126766) in patients with advanced solid tumours. VS-6766 (RO5126766) is the same compound as CH5126766. There are two parts to this study, the dose escalation phase and the dose expansion phase. In the dose escalation phase, cohorts of 3 to 6 patients will be enrolled to determine the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D). This will be followed by a dose expansion phase to further characterise the safety and tolerability and to assess the pharmacodynamic activity of the combination.
Trial Details
NCT Number NCT03875820
Lead Sponsor Institute of Cancer Research, United Kingdom
Collaborators: Verastem, Inc.
Conditions
(from sponsor)		 NSCLC, Low Grade Serous Ovarian Cancer, Endometrioid Carcinoma, Pancreatic Cancer
Related terms Carcinoma, Endometrioid, Pancreatic Neoplasms
Enrollment 87 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov