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Infigratinib for Achondroplasia
Study Summary
This trial is testing a new drug for children with achondroplasia who have participated in a previous study for at least six months. The new drug is designed to target fibroblast growth factor receptors 1-3. The trial will include dose escalation and expansion, as well as a pharmacokinetic substudy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- You have another serious health condition that could make it difficult to evaluate the effectiveness or safety of infigratinib.I have had a bone break in the last year.I have a condition causing short stature, but it's not achondroplasia.I have had cancer before.I have never been treated with CNP analogs, FGF ligand traps, or FGFR inhibitors.I have started my menstrual periods.I have been on oral steroids for more than 3 weeks, but inhaled steroids for asthma are okay.I am on medication that affects liver enzymes or changes calcium/phosphorus levels.My height is much shorter or taller than average for my age and sex.I can walk and stand up on my own without help.I can take pills by mouth.I have a current eye condition affecting my cornea or retina.I have had surgery to lengthen my limbs or correct their growth.I have been diagnosed with ACH through clinical assessment and genetic testing.I haven't taken growth hormone, IGF-1, or steroids in the last 6 months.I have not used any experimental drugs or devices for ACH or growth issues.
- Group 1: Infigratinib 0.016 mg/kg
- Group 2: Infigratinib 0.064 mg/kg
- Group 3: Infigratinib 0.25 mg/kg
- Group 4: Infigratinib 0.128 mg/kg
- Group 5: Infigratinib 0.032 mg/kg
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Are we recruiting new participants for this research?
"This trial is still open to patients, as reported on clinicaltrials.gov. The trial was first posted on March 10, 2020, and was last edited on April 5, 2022."
Does this research allow for people below 35 years of age?
"In order to take part in this clinical trial, patients must be aged between 3 and 11 years old. Out of the 25 total clinical trials, 14 are for patients aged under 18 and 11 are for patients aged 65 and over."
How many individuals are consenting to participate in this research?
"In order to carry out this research 78 patients are needed, these patients must meet the specified inclusion criteria. The patients can come from multiple sites, two examples being Vanderbilt University Medical Center which is located in Nashville, Tennessee and Stollery Children's Hosptial situated in Edmonton, Alberta."
Has the FDA cleared Infigratinib 0.128 mg/kg for patient use?
"Infigratinib 0.128 mg/kg is in Phase 2 of clinical trials, so there is some evidence of its safety, but its efficacy has yet to be explored. Our team at Power put its safety at a 2."
What is the efficacy of Infigratinib 0.128 mg/kg in other patient populations?
"Infigratinib 0.128 mg/kg was first studied in the year 2016 at Memorial Sloan Kettering Cancer Center. So far there have been 6 completed trials. There are currently 10 live trials, with many of these studies concentrated in Nashville, Tennessee."
What are the primary uses of Infigratinib 0.128 mg/kg?
"Infigratinib 0.128 mg/kg is an effective treatment for human patients with unresectable, metastatic cholangiocarcinomas who have the FGFR2 protein."
What is the target population for this clinical trial?
"Children with achondroplasia, aged 3-11, who have also completed at least 6 months of growth assessment in the PROPEL study (Protocol QBGJ398-001) are eligible to participate. To be accepted, participants must also be able to walk without assistance and stand unaided."
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