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Gamitrinib for Advanced Cancer

This study is testing a new drug called gamitrinib in people with advanced cancer, including lymphoma and solid tumors, that hasn't responded to standard treatments or for which no standard treatment exists. This is a "first-in-human" study, meaning it's the first time gamitrinib is being given to people. The main goal is to find out if gamitrinib is safe, what side effects it might cause, and the highest dose that can be given without causing too many problems (maximum tolerated dose, or MTD). Researchers will also look for the best dose to use in future studies. The study is open to adults aged 18 and older. The current status of this study is unclear.

Study design
This is a Phase I, open-label study, meaning you and your doctors will know what treatment you are receiving. It is a dose-escalation and dose-expansion study, aiming to enroll 42 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, determining the MTD and/or RP2D of gamitrinib, is measured at 7 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04827810

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Fox Chase Cancer Center
~42 participants
Updated 2025-06-29 on ClinicalTrials.gov
What's tested:Gamitrinib

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Determine the MTD and/or RP2D of gamitrinib when administered once weekly.
Measured over 7 years

Conditions

Lymphoma
Advanced Solid Tumor

Explore related trials

LymphomaSolid Neoplasm

NCT04827810

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvaniastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Anthony Olszanski, MD
[email protected]
215-728-5673
Email the study team

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Eligibility criteria

Inclusion

Histologically confirmed diagnosis of advanced cancer refractory to standard of care therapy, or for whom no standard of care therapy is available. Any numbers of prior therapies are allowed.
Dose escalation phase: Solid tumors and lymphoma may have measurable or evaluable disease as per Response Evaluation Criteria in Solid Tumors (RECIST v. 1.1) or as per RECIL 2017 criteria
Dose expansion phase:
All previous therapies of cancer, including radiotherapy major surgery and investigational therapies must be discontinued for ≥14 days (≥ 28 days for mitomycin C or nitrosoureas) before Cycle 1 Day 1 (C1D1), and all acute effects of any prior therapy must have resolved to baseline severity or Grade ≤ 1 Common Terminology Criteria for Adverse Events (CTCAE v5), except alopecia or parameters defined in this eligibility list.
Age \> 18 years.
ECOG performance status 0- 2
Patients must have normal organ and marrow function as defined below
Absolute neutrophil count ≥1,500/mm3 without growth factor use ≤ 7 days prior to C1D1 Platelets ≥85,000/mm3 without platelet transfusion ≤ 7 days prior to C1D1 Hemoglobin \>8.5 mg/dL without red blood cell transfusion ≤ 7 days prior to C1D1 Total serum bilirubin \<1.5 X upper limit of normal (ULN) (except for patients with documented Gilbert's syndrome) AST (SGOT)/ALT (SGPT) ≤2 X ULN; ≤ 5 X ULN if liver dysfunction is felt to be secondary to tumor burden Serum creatinine ≤ 1.5 X ULN (OR creatinine clearance ≥ 60 mL/min/1.73 m2) Serum or urine pregnancy test (WOCBP only) negative ≤7 days of C1D1
Ability to understand and willingness to sign a written informed consent, HIPAA consent document and comply with the study scheduled visits, treatment plans, laboratory tests and other procedures.
Female patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of the trial and for at least 90 days after completion of treatment. Male patients must be surgically sterile or must agree to use effective contraception during the period of the trial and for at least 90 days after completion of treatment. The decision of effective contraception will be based on the judgment of the principal investigator or a designated associate.

Exclusion

Patients with symptomatic brain metastases are excluded. Patients with asymptomatic and treated CNS metastases may participate in this trial. The patient must have completed any prior treatment for CNS metastases \> 28 days prior to study entry, including radiotherapy or surgery. Concurrent use of steroids for the treatment of brain metastasis are not permitted.
Current treatment on another (therapeutic) clinical trial
Hypertension not adequately controlled with medications (\>150/100 mm Hg despite optimal medical therapy)
Active bacterial fungal or viral infection including hepatitis B (HBV), hepatitis C (HCV), requiring treatment with IV antibiotic, IV anti-fungal, or anti-viral (Testing is not required for eligibility).
Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness (testing is not required for eligibility).
Any of the following in the previous 6 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism.
Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, or in the judgment of the investigator would make the patient inappropriate for entry into the study
Pregnant or breast feeding. Refer to section 4.4 for further detail.

What this trial measures

  • Determine the MTD and/or RP2D of gamitrinib when administered once weekly.7 years

    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).