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Led by Fox Chase Cancer Center · Updated on 2025-06-29
42
Participants Needed
1
Research Sites
26 weeks
Total Duration
Researchers are evaluating the safety and appropriate dosing of gamitrinib, a small molecule mitochondrial-targeted Hsp90 inhibitor, in patients with advanced cancers. This first-in-human, phase I, open-label study aims to identify dose-limiting toxicities and the maximum tolerated dose in patients with advanced solid tumors or lymphoma. The study builds on preclinical evidence showing gamitrinibs unique mechanism and preliminary safety profile. Gamitrinib is given as a one-hour intravenous infusion once weekly in 28-day treatment cycles. The study includes a dose-escalation phase with up to 36 patients receiving increasing doses starting at 10 mg, following a 33 design. Following dose escalation, up to six patients will receive the maximum tolerated dose in a dose-expansion phase to explore pharmacodynamic effects through tumor biopsies taken before and during treatment. Participants will undergo regular assessments including safety monitoring, pharmacokinetic blood tests, and tumor biopsies for pharmacodynamic evaluation. Researchers will measure the maximum tolerated dose, recommended dose for phase II, and pharmacokinetic parameters such as peak concentration and clearance. The trial lasts up to seven years, covering treatment and follow-up to assess safety, pharmacodynamics, and any anti-tumor activity.
CONDITIONS
A Phase I Safety and Pharmacokinetic Study of Gamitrinib Administered Intravenously to Patients With Advanced Cancer
A
Anthony Olszanski, MD
M
Matthew Zibelman, MD
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Fox Chase Cancer Center
Lead Sponsor
National Institutes of Health (NIH)
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Gamitrinib Dose-Escalation (Trial Group) | Current Guideline-Based Therapy (Context) |
|---|---|---|
| What it is | A small molecule inhibitor targeting mitochondrial Hsp90, given intravenously in escalating doses to patients with advanced cancer who have no standard treatment options. | Current guideline-based therapy may include further chemotherapy, immunotherapy, targeted drugs, or clinical trial referral for patients with advanced solid tumors or lymphoma who are refractory to previous treatments. |
| Role in trial | Investigational therapy evaluated for safety, dose-limiting toxicity, pharmacokinetics, and recommended phase II dosing. All participants received Gamitrinib at protocol-assigned doses. | Guidelines recommend that patients unable to benefit from standard therapy consider additional chemotherapy, immunotherapy, targeted agents, or clinical trial enrollment. |
| Primary use | The study determined Gamitrinib's safety, dose-limiting toxicities, pharmacokinetics, and recommended phase II dosing in adults with advanced cancer. | Guideline-based therapies aim to control disease progression, prolong survival, manage symptoms, or refer patients for investigational options when standard treatments fail. |
| How it is given/performed | Gamitrinib was administered intravenously once weekly, with dose escalation to determine the maximum tolerated dose and dose-expansion at the recommended phase II dose. | Guideline-based therapies may be administered as intravenous infusions or oral drugs, depending on regimen type. Dosing, scheduling, and drug selection follow standard local protocols. |
| Evidence status | Evidence includes preclinical studies and ongoing phase I investigation; clinical efficacy and safety data are not yet established for Gamitrinib in humans. | Guideline-based therapies have extensive published evidence demonstrating their effectiveness and safety profiles for relevant patient populations, with variation by regimen and disease subtype. |
| Important limitations | First-in-human study with no published clinical effectiveness or safety results. All trial participants received escalating doses of Gamitrinib; patient numbers, follow-up duration, and generalizability remain limited. Safety and efficacy must be established in ongoing and future trials. | Guideline-based therapies may be limited by previous resistance, toxicity, individual patient factors, or lack of further effective options. Selection depends on tumor characteristics, prior response, and patient tolerance. Not every patient is eligible for additional therapy, and rapid disease progression may preclude all options. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 7 years
Participants receive intravenous gamitrinib once weekly to assess safety, pharmacokinetics, and determine the maximum tolerated dose.
Weekly visits for dosing and assessments
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
7
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Umar Hayat, Gary T Elliott, Anthony J Olszanski...
https://pubmed.ncbi.nlm.nih.gov/35129069/Fox Chase Cancer Center
Lead Sponsor
National Institutes of Health (NIH)
Collaborating Sponsor
