GliomaEarly Phase 1NCT04424966
Infigratinib in Recurrent High-Grade Glioma Patients
A Early Phase 1 study testing Infigratinib in people with Glioma and Glioblastoma, run by Nader Sanai at 3 sites in United States.
Trial summary
This trial is an open-label, multicenter, Phase 0 trial that will enroll up to 20 participants with recurrent high-grade glioma with FGFR1 K656E or FGFR3 K650E mutation or FGFR3-TACC3 translocation which are scheduled for resection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma, Glioblastoma, GBM
- What is being tested?
- Infigratinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 3 sitesUnited States
- Study dates
- 21 Jul 2020to 19 Feb 2024
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prior resection of histologically diagnosed high-grade gliomas (III and IV) defined as participants who have progressed on or following standard (Stupp regimen) therapy, which included maximal surgical resection, temozolomide, and fractionated radiotherapy.
- Recurrence must be confirmed by diagnostic biopsy with local pathology review or contrast-enhanced MRI.
- Have measurable disease preoperatively, defined as at least 1 contrast-enhancing lesion, with 2 perpendicular measurements of at least 1 cm, as per RANO criteria.
- Sufficient archival tissue available to confirm eligibility.
- Archival tissue must demonstrate: FGFR1 K656E or FGFR3 K650E mutation or FGFR3-TACC3 translocation from NGS sequencing or IHC and RT-PCR.
- Ability to understand and the willingness to sign a written informed consent document (personally or by the legally authorized representative, if applicable).
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- Has voluntarily agreed to participate by giving written informed consent (personally or via legally authorized representative(s), and assent if applicable). Written informed consent for the protocol must be obtained prior to any screening procedures. If consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness.
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other procedures.
- Age ≥18 at time of consent
- Have a performance status (PS) of ≤2 on the Eastern Cooperative Oncology (Group (ECOG) scale (Oken et al. 1982)
- Ability to swallow oral medications.
- Has adequate bone marrow and organ function as defined by the following laboratory values (as assessed by the local laboratory for eligibility):
- Adequate bone marrow function:
- absolute neutrophil count ≥1,000/mcL
- Platelets (at time of surgery) ≥100,000/mcL
- hemoglobin ≥8.0 g/dL Participants may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator.
- Adequate hepatic and renal function:
- total bilirubin ≤1.5 X ULN Participants with Gilbert's syndrome with a total bilirubin ≤2.0 times ULN and direct bilirubin within normal limits are permitted.
- AST(SGOT) ≤3 X institutional ULN
- ALT(SGPT) ≤3 X institutional ULN
- Calculated or measured creatinine clearance ≥45 mL/min
- Other Lab Values:
- Amylase or lipase ≤2 X institutional ULN
- calcium or phosphorus, or calcium-phosphorus product <55 mg2/dL2
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- Inorganic phosphorus within normal limits
- Total corrected serum calcium within normal limits
- Confirmed negative serum pregnancy test (β-hCG) before starting study treatment or participant has had a hysterectomy.
- For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 3 months after the end of treatment administration.
- For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner and for an additional 1 month after the end of treatment administration. A condom is required to be used also by vasectomized men as well as during intercourse with a male partner to prevent delivery of the drug via seminal fluid.
- Agreement to adhere to Lifestyle Considerations throughout study duration.
- Participants who received chemotherapy must have recovered (Common Terminology Criteria for Adverse Events [CTCAE] Grade ≤1) from the acute effects of chemotherapy except for residual alopecia or Grade 2 peripheral neuropathy prior to Day 1. A washout period of at least 21 days is required between last chemotherapy dose and Day 1 (provided the patient did not receive radiotherapy).
- Participants who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and Day 1.
Who cannot join
- Have a history of liver transplant.
- Have impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral infigratinib (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection).
- Known active systemic bacterial infection (requiring intravenous [IV] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C [for example, hepatitis B surface antigen positive]. Screening is not required for enrollment.
- Have a history and/or current evidence of extensive tissue calcification including, but not limited to, the soft tissue, kidneys, intestine, myocardium, vascular system, and lung with the exception of calcified lymph nodes, minor pulmonary parenchymal calcifications, and asymptomatic coronary calcification.
- Have current evidence of corneal or retinal disorder/keratopathy including, but not limited to, bullous/band keratopathy, inflammation or ulceration, keratoconjunctivitis confirmed by ophthalmic examination. Subjects with asymptomatic ophthalmic conditions assessed by the investigator to pose minimal risk for study participation may be enrolled in the study.
- Have current evidence of endocrine alterations of calcium/phosphate homeostasis, e.g., parathyroid disorders, history of parathyroidectomy, tumor lysis, tumoral calcinosis etc.
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- Have had a recent (≤3 months prior to first dose of study drug) transient ischemic attack or stroke.
- CTCAE (v5.0) Grade ≥2 hearing loss.
- CTCAE (v5.0) Grade ≥2 neuropathy.
- Have clinically significant cardiac disease including any of the following:
- Known congestive heart failure requiring treatment (New York Heart Association Grade ≥2), LVEF <50% or local lower limit of normal as determined by MUGA scan or echocardiogram (ECHO), or uncontrolled hypertension (refer to the European Society of Cardiology and European Society of Hypertension guidelines [Williams et al 2018]).
- Presence of Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grade ≥2 ventricular arrhythmias, atrial fibrillation, bradycardia, or conduction abnormality.
- Unstable angina pectoris or acute myocardial infarction ≤3 months prior to first dose of study drug.
- QTcF >470 msec (males and females). Note: If the QTcF is >470 msec in the first ECG, a total of 3 ECGs separated by at least 5 minutes should be performed. If the average of these 3 consecutive results for QTcF is ≤470 msec, the participant meets eligibility in this regard.
- Known history of congenital long QT syndrome.
- Has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment [e.g. estimated creatinine clearance <30ml/min], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea).
- Prior therapy with any mitogen-activated protein kinase (MEK) or FGFR inhibitor. Prior therapy is defined as a therapeutic dosing, as determined by the Investigator.
- Are currently receiving or are planning to receive during participation in this study, treatment with agents that are known strong inducers or inhibitors of CYP3A4 and medications which increase serum phosphorus and/or calcium concentration. Participants are not permitted to receive enzyme-inducing anti-epileptic drugs, including carbamazepine, phenytoin, phenobarbital, and primidone.
- Current use of coumarin-derived anticoagulant for treatment, prophylaxis or otherwise. Therapy with heparin, low molecular weight heparin (LMWH) or fondaparinux is allowed.
- Have any known hypersensitivity to gemcitabine, cisplatin, calcium-lowering agents, infigratinib, or their excipients.
- Treatment with another investigational drug or other intervention within 30 days prior to enrollment or within 5 half-lives of the investigational product, whichever is longer.
- Have consumed grapefruit, grapefruit juice, grapefruit hybrids, pomegranates, star fruits, pomelos, Seville oranges or products containing juice of these fruits within 7 days prior to first dose of study drug.
- Have used medications known to prolong the QT interval and/or are associated with a risk of Torsades de Pointes (TdP) 7 days prior to first dose of study drug.
- Have used amiodarone within 90 days prior to first dose of study drug.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Chandler Regional Medical Center
Chandler, Arizona, 85224
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
HonorHealth Scottsdale Osborn Medical Center
Scottsdale, Arizona, 85251
About this study
Official title: A Phase 0 Study of Infigratinib in Recurrent High-Grade Glioma Participants Scheduled for Resection to Evaluate Central Nervous System (CNS) Penetration With PK Triggered Expansion Cohort
This trial is an open-label, multicenter, Phase 0 trial that will enroll up to 20 participants with recurrent high-grade glioma with FGFR1 K656E or FGFR3 K650E mutation or FGFR3-TACC3 translocation which are scheduled for resection. In the lead-in cohort, a total of 20 participants will be enrolled into the proposed phase 0 clinical trial. Participants will be administered infigratinib prior to surgical resection of their tumor.
- Conditions
- Glioma, Glioblastoma, GBM
- Being tested
- Infigratinib
- Medical subject headings
- Glioma, Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfigratinibDrug
The Phase 0 study will include treatment of recurrent high-grade glioma participants with 125 mg of infigratinib 7 days prior to surgical resection. Participants with tumors demonstrating PK-response will continue treatment with the same dose continuously for 21 days in 28-day cycles after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Phase 0: 125 mg of infigratinib administered orally for 7 days prior to surgical resection.
Expansion Cohort: 125 mg of infigratinib administered orally for 21 days of a 28-day treatment cycles. Receives: Drug: Infigratinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Concentration of Infigratinib in Enhancing and Non-Enhancing Tumor Tissue
Phase 0: Total infigratinib concentration in Gd enhancing and Gd non-enhancing tumor tissue collected intraoperatively, approximately 8 hours after study drug administration, will be determined by a validated liquid chromatography-mass spectrometry (LC-MS) method.
Measured: Intraoperative
Unbound Concentration of Infigratinib in Enhancing and Non-Enhancing Tumor Tissue
Phase 0: Unbound infigratinib concentration in Gd enhancing and Gd non-enhancing tumor tissue collected intraoperatively, approximately 8 hours after study drug administration, will be determined by a validated liquid chromatography-mass spectrometry (LC-MS) method.
Measured: Intraoperative
Total Concentration of Infigratinib in Plasma
Phase 0: Total infigratinib concentration in blood plasma collected intraoperatively, approximately 8 hours after study drug administration, will be determined by a validated liquid chromatography-mass spectrometry (LC-MS) method.
Measured: Intraoperative
Unbound Concentration of Infigratinib in Plasma
Phase 0: Unbound infigratinib concentration in blood plasma collected intraoperatively, approximately 8 hours after study drug administration, will be determined by a validated liquid chromatography-mass spectrometry (LC-MS) method.
Measured: Intraoperative
Total Concentration of Infigratinib in Cerebrospinal Fluid (CSF)
Phase 0: Total infigratinib concentration in cerebrospinal fluid (CSF) collected intraoperatively, approximately 8 hours after study drug administration, will be determined by a validated liquid chromatography-mass spectrometry (LC-MS) method.
Measured: Intraoperative
Unbound Concentration of Infigratinib in Cerebrospinal Fluid (CSF)
Phase 0: Unbound infigratinib concentration in cerebrospinal fluid (CSF) collected intraoperatively, approximately 8 hours after study drug administration, will be determined by a validated liquid chromatography-mass spectrometry (LC-MS) method.
Measured: Intraoperative
6-month Progression-Free Survival (PFS6) in Expansion Phase Participants
Proportion of participants who remain alive without disease progression at 6 months
Measured: From the date of Phase 0 surgery until the first documentation of disease progression or death due to any cause, assessed up to 6 months
Secondary outcomes (6)
Mean % Change of pERK+ Cells in Resected Post-Treatment Recurrent HGG Tissue vs Baseline Tissue
Phase 0: The mean percentage change of pERK positive cells in resected post-treatment recurrent high-grade glioma tumor tissue compared to baseline (archival primary high-grade glioma tumor tissue collected at screening) will be quantified using immunohistochemistry.
Measured: Baseline, Intraoperatively
Mean % Change of MIB-1+ Cells in Resected Post-Treatment Recurrent HGG Tissue vs Baseline Tissue
Phase 0: The mean percentage change of MIB-1 positive cells in resected post-treatment recurrent high-grade glioma tumor tissue compared to baseline (archival primary high-grade glioma tumor tissue collected at screening) will be quantified using immunohistochemistry.
Measured: Baseline, Intraoperatively
Mean % Change of ClCas3+ Cells in Resected Post-Treatment Recurrent HGG Tissue vs Baseline Tissue
Phase 0: The mean percentage change of ClCase3 positive cells in resected post-treatment recurrent high-grade glioma tumor tissue compared to baseline (archival primary high-grade glioma tumor tissue collected at screening) will be quantified using immunohistochemistry.
Measured: Baseline, Intraoperatively
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Assessed by CTCAE v5.0
Expansion Phase: An AE that began after the start of study medication treatment; or if the event was continuous from baseline and was serious, study medication-related, or resulted in death, discontinuation, or interruption or reduction of trial therapy.
Measured: From date of first dose until 7 days after last dose, assessed over 2 years 6 months
Number of Participants With Treatment-Related Adverse Events (TRAEs) Assessed by CTCAE v5.0
Expansion Phase: TRAEs are those deemed definitely, probably, and potentially related to the study drug.
Measured: From date of first dose until 7 days after last dose, assessed over 2 years 6 months
Number of Participants With Serious Adverse Events
Expansion Phase: AE severity as defined according to CTCAE v5.0.
Measured: From date of first dose until 30 days after last dose, assessed over 2 years 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start21 Jul 2020
- Primary completion31 Jan 2023
- Study completion19 Feb 2024
Why it stopped: Study drug no longer available.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for GliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nader Sanai
- Sponsor type
- University, hospital or other
- Collaborators
- Ivy Brain Tumor Center, Barrow Neurological Institute, QED Therapeutics, a BridgeBio company
- Responsible party
- Sponsor-investigator, Nader Sanai, St. Joseph's Hospital and Medical Center, Phoenix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04424966
- Sponsor's protocol ID
- 2020-08
- Other IDs
- 20-500-092-34-38
- Status last verified
- Sep 2025
- First submitted
- 27 May 2020
- Last updated
- 24 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 0 Study of Infigratinib in Recurrent High-Grade Glioma Participants Scheduled for Resection to Evaluate Central Nervous System (CNS) Penetration With PK Triggered Expansion Cohort
- ClinicalTrials.gov ID
- NCT04424966
- Acronym / sponsor ID
- 2020-08
- Conditions
- Glioma, Glioblastoma, GBM
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study drug no longer available.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Nader SanaiUniversity, hospital or other
- Collaborators
- Ivy Brain Tumor Center, Barrow Neurological Institute, QED Therapeutics, a BridgeBio company
- Study start
- 21 Jul 2020 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 19 Feb 2024 (actual)
- First posted
- 11 Jun 2020 (actual)
- Results
- Posted 24 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is an open-label, multicenter, Phase 0 trial that will enroll up to 20 participants with recurrent high-grade glioma with FGFR1 K656E or FGFR3 K650E mutation or FGFR3-TACC3 translocation which are scheduled for resection. In the lead-in cohort, a total of 20 participants will be enrolled into the proposed phase 0 clinical trial. Participants will be administered infigratinib prior to surgical resection of their tumor.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: InfigratinibPhase 0: 125 mg of infigratinib administered orally for 7 days prior to surgical resection. Expansion Cohort: 125 mg of infigratinib administered orally for 21 days of a 28-day treatment cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (33 listed)
- Prior resection of histologically diagnosed high-grade gliomas (III and IV) defined as participants who have progressed on or following standard (Stupp regimen) therapy, which included maximal surgical resection, temozolomide, and fractionated radiotherapy.
- Recurrence must be confirmed by diagnostic biopsy with local pathology review or contrast-enhanced MRI.
- Have measurable disease preoperatively, defined as at least 1 contrast-enhancing lesion, with 2 perpendicular measurements of at least 1 cm, as per RANO criteria.
- Sufficient archival tissue available to confirm eligibility.
- Archival tissue must demonstrate: FGFR1 K656E or FGFR3 K650E mutation or FGFR3-TACC3 translocation from NGS sequencing or IHC and RT-PCR.
Key exclusion criteria (24 listed)
- Have a history of liver transplant.
- Have impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral infigratinib (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection).
- Known active systemic bacterial infection (requiring intravenous [IV] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C [for example, hepatitis B surface antigen positive]. Screening is not required for enrollment.
- Have a history and/or current evidence of extensive tissue calcification including, but not limited to, the soft tissue, kidneys, intestine, myocardium, vascular system, and lung with the exception of calcified lymph nodes, minor pulmonary parenchymal calcifications, and asymptomatic coronary calcification.
- Have current evidence of corneal or retinal disorder/keratopathy including, but not limited to, bullous/band keratopathy, inflammation or ulceration, keratoconjunctivitis confirmed by ophthalmic examination. Subjects with asymptomatic ophthalmic conditions assessed by the investigator to pose minimal risk for study participation may be enrolled in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InfigratinibThe Phase 0 study will include treatment of recurrent high-grade glioma participants with 125 mg of infigratinib 7 days prior to surgical resection. Participants with tumors demonstrating PK-response will continue treatment with the same dose continuously for 21 days in 28-day cycles after surgery. | Drug | Arm 1 |
Primary outcome
Total Concentration of Infigratinib in Enhancing and Non-Enhancing Tumor Tissue
Time frame: Intraoperative
Phase 0: Total infigratinib concentration in Gd enhancing and Gd non-enhancing tumor tissue collected intraoperatively, approximately 8 hours after study drug administration, will be determined by a validated liquid chromatography-mass spectrometry (LC-MS) method.
Unbound Concentration of Infigratinib in Enhancing and Non-Enhancing Tumor Tissue
Time frame: Intraoperative
Phase 0: Unbound infigratinib concentration in Gd enhancing and Gd non-enhancing tumor tissue collected intraoperatively, approximately 8 hours after study drug administration, will be determined by a validated liquid chromatography-mass spectrometry (LC-MS) method.
Total Concentration of Infigratinib in Plasma
Time frame: Intraoperative
Phase 0: Total infigratinib concentration in blood plasma collected intraoperatively, approximately 8 hours after study drug administration, will be determined by a validated liquid chromatography-mass spectrometry (LC-MS) method.
Unbound Concentration of Infigratinib in Plasma
Time frame: Intraoperative
Phase 0: Unbound infigratinib concentration in blood plasma collected intraoperatively, approximately 8 hours after study drug administration, will be determined by a validated liquid chromatography-mass spectrometry (LC-MS) method.
Total Concentration of Infigratinib in Cerebrospinal Fluid (CSF)
Time frame: Intraoperative
Phase 0: Total infigratinib concentration in cerebrospinal fluid (CSF) collected intraoperatively, approximately 8 hours after study drug administration, will be determined by a validated liquid chromatography-mass spectrometry (LC-MS) method.
Unbound Concentration of Infigratinib in Cerebrospinal Fluid (CSF)
Time frame: Intraoperative
Phase 0: Unbound infigratinib concentration in cerebrospinal fluid (CSF) collected intraoperatively, approximately 8 hours after study drug administration, will be determined by a validated liquid chromatography-mass spectrometry (LC-MS) method.
6-month Progression-Free Survival (PFS6) in Expansion Phase Participants
Time frame: From the date of Phase 0 surgery until the first documentation of disease progression or death due to any cause, assessed up to 6 months
Proportion of participants who remain alive without disease progression at 6 months
6 secondary outcomes
Mean % Change of pERK+ Cells in Resected Post-Treatment Recurrent HGG Tissue vs Baseline Tissue
Time frame: Baseline, Intraoperatively
Mean % Change of MIB-1+ Cells in Resected Post-Treatment Recurrent HGG Tissue vs Baseline Tissue
Time frame: Baseline, Intraoperatively
Mean % Change of ClCas3+ Cells in Resected Post-Treatment Recurrent HGG Tissue vs Baseline Tissue
Time frame: Baseline, Intraoperatively
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Assessed by CTCAE v5.0
Time frame: From date of first dose until 7 days after last dose, assessed over 2 years 6 months
Number of Participants With Treatment-Related Adverse Events (TRAEs) Assessed by CTCAE v5.0
Time frame: From date of first dose until 7 days after last dose, assessed over 2 years 6 months
Number of Participants With Serious Adverse Events
Time frame: From date of first dose until 30 days after last dose, assessed over 2 years 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Ivy Brain Tumor Center WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Infigratinib in people with Glioma and Glioblastoma, run by Nader Sanai at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 33 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Concentration of Infigratinib in Enhancing and Non-Enhancing Tumor Tissue (time frame: Intraoperative). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2025.