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FGFR Inhibitor
Pre-Surgery Infigratinib for Urothelial Cancer
Phase 1 & 2
Waitlist Available
Led By Mehrad Adibi, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Calculated or measured creatinine clearance >= 30 mL/min
Have an Eastern Cooperative Oncology Group (ECOG) performance status =< 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year post surgery
Awards & highlights
Study Summary
This trial is testing the side effects of a drug called infigratinib before surgery in patients with upper tract urothelial cancer. The drug may help shrink the tumor, making surgery easier.
Who is the study for?
This trial is for adults with upper tract urothelial cancer who can provide a biopsy, have adequate kidney function, and are physically able to participate. Women of childbearing potential must test negative for pregnancy and agree to use contraception. Participants should not have other cancers or conditions that could interfere with the study, nor be on certain medications affecting enzyme activity.Check my eligibility
What is being tested?
The trial tests Infigratinib's effects when given before surgery to shrink tumors in patients with upper tract urothelial cancer. It examines if pre-surgery treatment makes the surgical procedure easier or reduces the need for more extensive surgery while assessing side effects and quality of life through questionnaires.See study design
What are the potential side effects?
Possible side effects include issues related to blocking FGFR gene activities which may affect cell growth processes. Specific side effects aren't listed but generally could involve reactions at the drug administration site, gastrointestinal disturbances, fatigue, skin changes, or abnormal blood counts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidneys are functioning well enough (creatinine clearance >= 30 mL/min).
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I can swallow and keep down pills.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year post surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year post surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events
Secondary outcome measures
Changes in patient reported quality of life outcomes
Circulating cell-free deoxyribonucleic acid (cfDNA) analysis
Expression of markers
+3 moreSide effects data
From 2023 Phase 2 trial • 158 Patients • NCT0215906623%
Hypoalbuminaemia
23%
Oedema peripheral
23%
Anaemia
15%
Gamma-glutamyltransferase increased
15%
Urinary tract infection
15%
Nausea
15%
Diarrhoea
15%
Blood creatine increased
15%
Visual field defect
15%
Blood creatine phosphokinase increased
15%
Blood creatinine increased
8%
Femur fracture
8%
Cancer pain
8%
Intestinal perforation
8%
Pyrexia
8%
Aphasia
8%
Vomiting
8%
Pain in extremity
8%
Rash maculo-papular
8%
Cardiac arrest
8%
Cardiac failure
8%
Colitis
8%
Gastrointestinal haemorrhage
8%
Fatigue
8%
Blood alkaline phosphatase increased
8%
Alanine aminotransferase increased
8%
Constipation
8%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part II: Encorafenib + Binimetinib + Capmatinib
Part I: Encorafenib + Binimetinib (Naive)
Part I: Encorafenib + Binimetinib (Non-naive)
Part II: Encorafenib + Binimetinib + Ribociclib
Part II: Encorafenib + Binimetinib + Infigratinib
Part II: Encorafenib + Binimetinib + Buparlisib
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (infigratinib, surgery)Experimental Treatment4 Interventions
Patients receive infigratinib PO QD on days 1-21. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. During weeks 8-9 (at least 48 hours after last dose of infigratinib), patients undergo surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Surgical Procedure
2016
Completed Phase 2
~150
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,138 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,766 Total Patients Enrolled
Mehrad Adibi, MDPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a known history of long QT syndrome.I have serious heart issues, including heart failure, low heart pump efficiency, uncontrolled high blood pressure, recent heart attack, or irregular heartbeat.I haven't had any cancer other than skin, cervical, or low-risk prostate cancer in the last 3 years.My kidney function is reduced with a creatinine clearance below 30 mL/min.I am not on blood thinners that affect CYP3A4 enzymes.I have a recent biopsy sample available for analysis.My kidneys are functioning well enough (creatinine clearance >= 30 mL/min).I have had a stroke or mini-stroke in the last 3 months.I have UTUC and am either undergoing surgery or cannot have cis-platin due to health issues or low risk of the disease spreading.I can take care of myself and am up and about more than half of my waking hours.My bladder cancer is under control and doesn't need systemic therapy after surgery.You have eaten grapefruit, pomegranates, star fruits, pomelos, Seville oranges, or products made with the juice of these fruits in the last 7 days before starting the study drug.I have an eye condition confirmed by an eye doctor but it's considered low risk for this study.I do not have major stomach or bowel problems that could affect medication absorption.I have a condition affecting my body's calcium or phosphate levels.I have taken amiodarone within the last 90 days.I have not taken any medications that affect heart rhythm in the last 7 days.I can swallow and keep down pills.I am not pregnant, can use effective birth control, or am not of childbearing potential.I am not taking medications that strongly affect certain liver enzymes or alter calcium/phosphorus levels.I have or had extensive calcification in organs except for minor lung, lymph node, and heart artery calcifications.I have recovered from side effects of cancer treatments, except for hair loss.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (infigratinib, surgery)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you elucidate what Infigratinib is typically employed to treat?
"Infigratinib is a viable therapeutic option for those with unresectable, metastatic cholangiocarcinomas who have been identified as having an fgfr2 protein mutation and wish to create advance directives."
Answered by AI
Is this research study currently accepting participants?
"Affirmative. The clinical trial's listing on clinicaltrials.gov reveals that recruitment is ongoing and began on July 28th 2020, with most recent updates posted October 17th 2022. This study requires 20 participants from a single medical centre to be enrolled."
Answered by AI
Has Infigratinib been previously studied in other scientific experiments?
"Currently, 10 clinical trials are actively exploring the effects of Infigratinib. Of those live studies, two have reached Phase 3. Although most research sites for this treatment reside in Columbus, Ohio; a total of 358 trial locations exist around the globe."
Answered by AI
To what extent are individuals participating in this investigation?
"Accurately, clinicaltrials.gov highlights the fact that this experiment is currently in search of individuals to include. This research was posted on July 28th 2020 and its details were most recently modified at October 17th 2022. The study requires 20 participants from a single centre."
Answered by AI
What potential risks exist for individuals taking Infigratinib?
"Infigratinib's safety rating is 1 due to its Phase 1 designation, signifying that there are currently limited data points confirming the drug's efficacy and security."
Answered by AI
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