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NCT04827810 · ClinicalTrials.gov registry record · Phase 1
A Phase I Safety and Pharmacokinetic Study of Gamitrinib Administered Intravenously to Patients With Advanced Cancer
A Phase 1 study of Lymphoma and Advanced Solid Tumor, sponsored by Fox Chase Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
- 1
- Study location
NCT04827810: Recruiting Phase 1 study of Lymphoma and Advanced Solid Tumor, sponsored by Fox Chase Cancer Center.
NCT04827810 is a Phase 1 study of Lymphoma and Advanced Solid Tumor that is actively recruiting participants, run by Fox Chase Cancer Center. The registered enrollment target is 42 participants, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04827810, a Phase 1 study of Lymphoma and Advanced Solid Tumor, is actively recruiting participants, sponsored by Fox Chase Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
First cycle dose-limiting toxicities. The maximally tolerated dose (MTD) is defined as the dose level below which the absolute observed DLT rate is \> 25%. The MTD is equivalent to the anticipated recommended phase 2 dose (RP2D).
Conditions Studied
Interventions
- DRUG Gamitrinib
Study Locations (1)
Pennsylvania
- Fox Chase Cancer Center - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2021-11-05 |
| Est. Completion | 2026-12-30 |
| Phase | Phase 1 |
What NCT04827810 shows while recruiting
NCT04827810 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (91% lower).
The record links to 2 conditions, with Lymphoma appearing as the primary indexed condition, and to 1 intervention - of which Gamitrinib is the first listed.
NCT04827810 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04827810 about?
NCT04827810 is a clinical study titled "A Phase I Safety and Pharmacokinetic Study of Gamitrinib Administered Intravenously to Patients With Advanced Cancer". 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 maxi...
What is the current status of trial NCT04827810?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2021-11-05. Estimated completion is 2026-12-30.
What conditions does trial NCT04827810 study?
This clinical trial studies the following conditions: Lymphoma, Advanced Solid Tumor.
What interventions are being tested in trial NCT04827810?
The interventions under investigation include: Gamitrinib (DRUG).
Who is sponsoring clinical trial NCT04827810?
This trial is sponsored by Fox Chase Cancer Center, which has 183 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04827810 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04827810's enrollment target sits among peer trials
42 169th of 299 higher than 129 of 299 other Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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