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

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Fox Chase Cancer Center
Study ID
NCT04827810
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Gamitrinib — DRUG
    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.

Study Details

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.

Key Dates

Start date
Nov 5, 2021
Status verified
Jun 2025
Primary completion
Jun 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
42 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose -1
    Accelerated Phase: - Standard Phase: 5 mg
  • Experimental: Dose 1
    Accelerated Phase: 10 mg Standard Phase: 10 mg
  • Experimental: Dose 2
    Accelerated Phase: 20 mg Standard Phase: 20 mg
  • Experimental: Dose 3
    Accelerated Phase: 40 mg Standard Phase: 35 mg
  • Experimental: Dose 4
    Accelerated Phase: 80 mg Standard Phase: 50 mg
  • Experimental: Dose 5
    Accelerated Phase: 160 mg Standard Phase: 65 mg
  • Experimental: Dose 6
    Accelerated Phase: 320 mg Standard Phase: 85 mg

Primary Outcome Measure

Determine the MTD and/or RP2D of gamitrinib when administered once weekly. [ Time Frame: 7 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111
Anthony J. Olszanski
[email protected]
215-214-1676
Anthony J. Olszanski (PRINCIPAL_INVESTIGATOR)

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By research site
Fox Chase Cancer Center· Philadelphia, PA

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