Actively Recruiting
A Phase I Safety and Pharmacokinetic Study of Gamitrinib Administered Intravenously to Patients With Advanced Cancer
Led by Fox Chase Cancer Center · Updated on 2025-06-29
42
Participants Needed
1
Research Sites
268 weeks
Total Duration
On this page
Sponsors
F
Fox Chase Cancer Center
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase I Safety and Pharmacokinetic Study of Gamitrinib Administered Intravenously to Patients With Advanced Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed advanced cancer refractory to standard therapy or with no available standard therapy
- For dose escalation, solid tumors and lymphoma may have measurable or evaluable disease per RECIST v1.1 or RECIL 2017 criteria
- For dose expansion, at least one measurable tumor site per RECIST v1.1 or RECIL 2017
- Willingness to undergo mandatory tumor biopsies before and during treatment (dose expansion phase)
- All prior cancer therapies stopped for at least 14 days (28 days for mitomycin C or nitrosoureas) before treatment start
- Age over 18 years
- ECOG performance status of 0 to 2
- Normal organ and marrow function as defined by blood counts and liver/kidney tests
- Negative pregnancy test for women of childbearing potential within 7 days before treatment
- Ability to understand and sign informed consent
- Use of effective contraception during and for 90 days after the trial for women and men if not surgically sterile
You will not qualify if you...
- Symptomatic brain metastases
- Current treatment in another therapeutic clinical trial
- Uncontrolled hypertension above 150/100 mm Hg despite medication
- Active infection requiring intravenous treatment
- Known HIV or AIDS-related illness
- Certain serious heart or vascular events within the last 6 months
- Other severe medical or psychiatric conditions increasing risk or interfering with study participation
- Pregnancy or breastfeeding
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Actively Recruiting
Research Team
A
Anthony Olszanski, MD
CONTACT
M
Matthew Zibelman, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
7
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