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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial is testing the side effects and best dose of two chemotherapy drugs, gemcitabine and cisplatin, when given with either of two targeted drugs, ivosidenib or pemigatinib, in treating patients with cholangiocarcinoma that cannot be removed with surgery or has spread to other places in the body.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of significant toxicities
Secondary outcome measures
Best response
Incidence of adverse events
Incidence of toxicities
+2 moreTrial 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
~1940
Gemcitabine
2017
Completed Phase 3
~2070
Ivosidenib
2019
Completed Phase 1
~20
Pemigatinib
2022
Completed Phase 2
~220
Find a Location
Who is running the clinical trial?
Academic and Community Cancer Research UnitedLead Sponsor
53 Previous Clinical Trials
5,128 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,145 Total Patients Enrolled
101 Trials studying Cholangiocarcinoma
9,762 Patients Enrolled for Cholangiocarcinoma
Shubham PantPrincipal InvestigatorAcademic and Community Cancer Research United
3 Previous Clinical Trials
123 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or can carry out light work.I do not have an ongoing infection needing treatment or a fever over 38.5°C.My cancer has a change in the FGFR2 gene.I haven't had another cancer within the last 5 years.I have recovered from side effects of my previous cancer treatments.My cancer hasn't worsened after 3 rounds of chemo with gemcitabine and cisplatin.My cancer has an IDH1 gene mutation.I am on medication that affects my heart's rhythm but it's being monitored.My biopsy from the last 3 years shows I have cholangiocarcinoma that can't be surgically removed.You must have a certain amount of a type of white blood cell called neutrophils, which will be measured within 21 days before the study begins.I am allergic to ivosidenib or pemigatinib.My liver enzymes are within acceptable limits, even with liver metastases.I have not had serious heart problems in the last 6 months.I cannot or do not want to take ivosidenib or pemigatinib orally due to GI issues.I have a tumor that can be measured by scans before starting chemotherapy.I am fully active or restricted in physically strenuous activity but can do light work.I am currently detained or incarcerated.You are currently taking part in another study for your cancer.My cancer has worsened despite current chemotherapy.I have a tumor that can be measured and tracked over time.My kidney function is within the normal range.I had liver-targeted cancer treatments less than 4 weeks ago.I need steroids for my brain metastases symptoms.I have been treated with an IDH or FGFR inhibitor before.My test results show a mutation in the IDH1 gene or a change in the FGFR2 gene.I agree to use two effective birth control methods.I have a serious eye condition affecting my cornea or retina.I have recovered from side effects of previous cancer treatments.I've had local treatments like embolization or radiation, but my measurable disease is outside those treated areas.My condition cannot be cured with surgery, transplantation, or targeted therapies.My bile duct cancer cannot be removed by surgery and was diagnosed within the last 3 years.I have a history of severe vitamin D deficiency needing high doses.I do not have active hepatitis B, C, HIV, or AIDS.My heart's electrical activity is normal and I'm not at risk for irregular heartbeats.You have a medical or mental condition that could make it dangerous for you to participate in the study or affect the accuracy of the study results.My cancer did not worsen after 3 rounds of chemotherapy with gemcitabine and cisplatin.I had to stop standard chemotherapy due to severe side effects.I had radiation for cancer spread less than 2 weeks ago.I haven't had major surgery in the last 4 weeks or still recovering from one.I am not taking any strong or moderate drugs that affect liver enzymes.I have a history of abnormal calcium deposits in my body.You are expected to live for at least three more months.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (ivosidenib, cisplatin, gemcitabine)
- Group 2: Arm B (pemigatinib, cisplatin, gemcitabine)
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.
Are there any current openings for participants in this trial?
"This medical trial is currently in the process of patient recruitment, with its initial post date being January 25th 2021. The study was last updated on June 24th 2022."
Answered by AI
What medical uses is Gemcitabine typically administered for?
"Gemcitabine is a common solution for treating urinary bladder conditions, but it can also help those with advanced testicular cancer, small cell lung cancer (SCLC), and various head & neck carcinomas."
Answered by AI
How many participants have been accepted into this research study?
"This trial requires the inclusion of 40 participants fitting its specific qualifications. Patients can join from various centres, among them Spartanburg Regional Medical Center in Forest City, North carolina and Mayo Clinic in Rochester, Minnesota."
Answered by AI
Are there any other research endeavors that have studied Gemcitabine?
"At present, Gemcitabine is the subject of 1056 clinical trials; 352 in Phase 3. With a great majority of these studies based in Shanghai, there are still 54 locations worldwide trialing this treatment."
Answered by AI
What potential risks are associated with Gemcitabine treatment?
"Preliminary data suggests that Gemcitabine is relatively safe, thus receiving a score of 1."
Answered by AI
How many healthcare facilities are administering this clinical experiment?
"This clinical trial is being held at Spartanburg Regional Medical Center in Forest City, North carolina; Mayo Clinic in Rochester, Minnesota; and Mayo Clinic in Arizona Scottsdale, Arizona. Additionally it is also taking place at 7 other medical centres."
Answered by AI
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