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Monoclonal Antibodies
Infigratinib for Bile Duct Cancer
Phase 1
Waitlist Available
Led By Sunyoung Lee, MD, PHD
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
Is refractory to, has demonstrated intolerance to, or has refused access to, available standard therapies. Refractory patients should have evidence of progressive disease on at least one prior standard chemotherapy regimen for advanced or metastatic disease. Patients who discontinued available standard therapy due to toxicity must have continued evidence of measurable disease.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year.
Awards & highlights
Study Summary
This trial is testing a combination of drugs to see what the highest tolerable dose is for patients with a certain type of cancer.
Eligible Conditions
- Bile Duct Cancer
- Liver Cancer
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You have tried and failed with standard treatment options available for your condition, or cannot tolerate them. You must have proof of continued disease progression or measurable disease if you stopped treatment due to side effects.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion; an average of 1 year.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year.
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, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Trial Design
2Treatment groups
Experimental Treatment
Group I: Part B (Dose Expansion)Experimental Treatment3 Interventions
Participants will receive infigratinib at the recommended dose that was found in Part A.
Group II: Part A (Dose Escalation)Experimental Treatment3 Interventions
The first group of participants will receive the lowest dose level of infigratinib.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2016
Completed Phase 3
~6040
Bevacizumab
2013
Completed Phase 4
~5280
Find a Location
Who is running the clinical trial?
Helsinn Healthcare SAIndustry Sponsor
41 Previous Clinical Trials
9,575 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,449 Total Patients Enrolled
Helsinn HealthcareUNKNOWN
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are prospective participants being accepted for this clinical investigation?
"The clinical trial database reveals that recruitment for this particular study has been halted. Despite being initially posted on February 28th 2023 and updated lastly on November 23rd 2022, no further participants are required at the moment. However, 280 other studies remain open to prospective candidates."
Answered by AI
How reliable is the efficacy of Infigratinib for individuals?
"Due to the limited clinical data available, Infigratinib received a safety rating of 1 on our scale. This is because it currently only in Phase 1 trials and there are minimal findings demonstrating its efficacy or safety."
Answered by AI
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