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A Phase I Safety and Pharmacokinetic Study of Gamitrinib Administered Intravenously to Patients With Advanced Cancer

StatusSuspended
PhasePhase 1
Started
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Record History

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  1. Recruitment suspended Sponsor's reason: Pending amendment to open further Cohorts Show 7 more changesShow less
    • Primary completion pushed from Jun 30, 2026 to Jun 30, 2027
    • Primary endpoints: details revised at 1 of 1 entry
    • Study completion pushed from Dec 30, 2026 to Dec 30, 2027
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints: details revised at 6 of 8 entries
    • Site details revised
    • Publications: details revised at 1 of 1 entry
  2. Trial status: Suspended to Recruiting
    • Site details revised
    v9
  3. Primary completion date: Dec 2028 to Jun 30, 2026
    • Study completion date: Dec 2029 to Dec 30, 2026
    v8
  4. Re-verified, no change to tracked fieldsv7
  5. Trial status: Recruiting to Suspended Sponsor's reason: Suspended temporarily due to limited drug supply
    • Site details revised
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Collaborators expanded, about 9 wordsv5
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Dec 2021 to Nov 5, 2021
    v4
  3. Start date: Oct 2021 to Dec 2021
    • Primary completion date: Oct 2028 to Dec 2028
    • Study completion date: Oct 2029 to Dec 2029
    v3
  4. Start date: Jul 2021 to Oct 2021
    • Primary completion date: Apr 2028 to Oct 2028
    • Study completion date: Apr 2029 to Oct 2029
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 first-in-human, phase I, open-label, non-randomized dose-escalation and dose-expansion study with the primary objective to determine the safety profile of small molecule, mitochondrial-targeted Hsp90 inhibitor, gamitrinib, including identification of dose-limiting toxicities (DLT) and maximum tolerated dose (MTD) in patients with advanced cancers. A secondary objective of the study is to determine the recommended dose and regimen(s) for a phase II study. This study is based on preclinical data demonstrating the anticancer activity, unique mechanism of action and preliminary safety of gamitrinib. In the dose-finding portion of this study, gamitrinib formulated in Lipoid S100®-based formulation will be administered as a 1-hour IV infusion once weekly for four weeks as 28-day treatment cycles. Up to 36 patients will be enrolled in the dose-escalation component of the study based on anticipated cohorts. The starting dose will be 10 mg, corresponding to allometric scaling) from the most sensitive species (rats) in the 29-day GLP toxicology and toxicokinetic studies with 14-day recovery period of gamitrinib. Dose-escalation will follow a 3+3 design. Six patients will be enrolled in the dose-expansion component of the study at MTD for the purpose of exploring pharmacodynamic effects via tumor pre and on-therapy biopsies.
Trial Details
NCT Number NCT04827810
Lead Sponsor Fox Chase Cancer Center
Collaborators: National Institutes of Health (NIH), National Cancer Institute (NCI)
Conditions
(from sponsor)		 Lymphoma, Advanced Solid Tumor
Related terms Lymphoma
Enrollment 42 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov