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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

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

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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year. for reporting.

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

Bevacizumab

2013

Completed Phase 4

~5280

Infigratinib

2020

Completed Phase 2

~20

Atezolizumab

2017

Completed Phase 3

~5860

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Helsinn Healthcare SAIndustry Sponsor

41 Previous Clinical Trials

9,459 Total Patients Enrolled

M.D. Anderson Cancer CenterLead Sponsor

2,976 Previous Clinical Trials

1,789,508 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

Recent research and studies

clinicaltrials.govStudy

Phase Ib Trial of Infigratinib In Combination With Atezolizumab And Bevacizumab for The Second-Line Treatment of Advanced Cholangiocarcinoma With FGFR2 Fusion/Amplification

2023. "Phase Ib Trial of Infigratinib In Combination With Atezolizumab And Bevacizumab for The Second-Line Treatment of Advanced Cholangiocarcinoma With FGFR2 Fusion/Amplification". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05510427.