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Alkylating Agent

Chemotherapy + Targeted Therapy for Bile Duct Cancer

Phase 1

Waitlist Available

Led By Shubham Pant

Research Sponsored by Academic and Community Cancer Research United

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG performance status of 0 or 1

At least one evaluable and measurable lesion by RECIST criteria prior to beginning chemotherapy with gemcitabine and cisplatin

Must not have

Active infection requiring systemic anti-infective therapy or unexplained fever > 38.5 degrees Celsius

Known hypersensitivity to any components of ivosidenib or pemigatinib

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 27 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a combination of standard chemotherapy with additional drugs to treat advanced bile duct cancer. It targets patients whose cancer can't be surgically removed or has spread. The treatment aims to kill cancer cells and block their growth mechanisms.

Who is the study for?

This trial is for adults with advanced cholangiocarcinoma (bile duct cancer) that can't be surgically removed or has spread, and who have specific genetic mutations (IDH1 or FGFR2). Participants must have had some chemotherapy already without their cancer getting worse and should be in good physical condition. Pregnant women, those with certain heart conditions, infections, or a history of severe reactions to similar drugs are excluded.

What is being tested?

The study is testing the combination of chemotherapy drugs gemcitabine and cisplatin with either ivosidenib or pemigatinib to see if they're more effective together than just chemotherapy alone. The goal is to find out the safest doses and how well these combinations work against this type of cancer.

What are the potential side effects?

Possible side effects include nausea, fatigue, liver issues from the chemotherapy drugs; plus swelling, joint pain or skin problems from ivosidenib/pemigatinib. There's also a risk of abnormal heart rhythm due to drug interactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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I have a tumor that can be measured and tracked over time.

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My cancer has a change in the FGFR2 gene.

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My cancer has an IDH1 gene mutation.

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I have a tumor that can be measured by scans before starting chemotherapy.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My kidney function is within the normal range.

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My test results show a mutation in the IDH1 gene or a change in the FGFR2 gene.

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I agree to use two effective birth control methods.

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My condition cannot be cured with surgery, transplantation, or targeted therapies.

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My cancer did not worsen after 3 rounds of chemotherapy with gemcitabine and cisplatin.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have an ongoing infection needing treatment or a fever over 38.5°C.

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I am allergic to ivosidenib or pemigatinib.

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I cannot or do not want to take ivosidenib or pemigatinib orally due to GI issues.

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I am currently detained or incarcerated.

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My cancer has worsened despite current chemotherapy.

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I had liver-targeted cancer treatments less than 4 weeks ago.

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I need steroids for my brain metastases symptoms.

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I have been treated with an IDH or FGFR inhibitor before.

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I do not have active hepatitis B, C, HIV, or AIDS.

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My heart's electrical activity is normal and I'm not at risk for irregular heartbeats.

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I had to stop standard chemotherapy due to severe side effects.

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I had radiation for cancer spread less than 2 weeks ago.

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I haven't had major surgery in the last 4 weeks or still recovering from one.

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I am not taking any strong or moderate drugs that affect liver enzymes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 27 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~27 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 27 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants With Significant Toxicities

Secondary study objectives

Best Response

Number of Participants Experiencing Toxicities

Number of Patients Experiencing Adverse Events

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm B (pemigatinib, cisplatin, gemcitabine)Experimental Treatment3 Interventions

Patients receive pemigatinib PO on days 1-21, cisplatin IV on days 1 and 8, and gemcitabine IV on days 1 and 8. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Group II: Arm A (ivosidenib, cisplatin, gemcitabine)Experimental Treatment3 Interventions

Patients receive ivosidenib PO on days 1-21, cisplatin IV on days 1 and 8, and gemcitabine IV on days 1 and 8. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cisplatin

2013

Completed Phase 3

~3120

Gemcitabine

2017

Completed Phase 3

~1920