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Alkylating agents/Anti-metabolites

Futibatinib for Cholangiocarcinoma (FOENIX-CCA3 Trial)

Q: How many individuals are enrolled in this research project?

<p>As noted by the sponsor, Taiho <a href="https://www.withpower.com/clinical-trials/oncology">Oncology</a>, Inc., a total of 216 individuals are needed to fill the clinical trial's requirements. The study will be conducted from multiple sites including Medical College of <a href="https://www.withpower.com/clinical-trials/wisconsin">Wisconsin</a> - Froedtert Hospital in Milwaukee, Wisconsin and Medical Oncology Associates, PS - Summit <a href="https://www.withpower.com/clinical-trials/cancer">Cancer</a> Centers in Spokane, <a href="https://www.withpower.com/clinical-trials/washington">Washington</a>.</p>

Phase 3

Waitlist Available

Research Sponsored by Taiho Oncology, Inc.

Eligibility Criteria Checklist

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

Must have

Patients who have received treatment for locally advanced disease (for example, trans-arterial chemoembolization, selective internal radiation therapy, external beam radiation) must have evidence of radiographic progression with measurable disease outside the previously-treated lesions

Is ≥18 years of age (or meets the country's regulatory definition for legal adult age)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to12 months

Awards & highlights

FOENIX-CCA3 Trial Summary

This trial is testing a new drug, futibatinib, against the standard chemotherapy treatment for bile duct cancer.

Who is the study for?

This trial is for adults with advanced, metastatic, or recurrent inoperable bile duct cancer (cholangiocarcinoma) that has a specific genetic change (FGFR2 gene rearrangements). Participants must have measurable disease, adequate organ function, and be able to take oral medication. They should not have had previous systemic cancer treatment or certain heart conditions. Women of childbearing potential must test negative for pregnancy and agree to use birth control.Check my eligibility

What is being tested?

The study compares the effectiveness and safety of futibatinib versus gemcitabine-cisplatin chemotherapy as first-line treatments. It's an open-label Phase 3 trial where patients are randomly assigned to one of two groups: one receiving futibatinib and the other receiving standard chemotherapy.See study design

What are the potential side effects?

Potential side effects may include issues related to liver function abnormalities due to underlying liver metastasis, retinal disorders if present before joining the study, uncontrolled ventricular arrhythmias or QT interval prolongation on ECGs indicating heart rhythm problems.

FOENIX-CCA3 Trial Eligibility Criteria

Inclusion Criteria

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

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My cancer has grown or spread after local treatment like radiation.

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I am 18 years old or older.

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My cancer is advanced or has returned, can't be surgically removed, and has a specific genetic change.

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I am fully active or can carry out light work.

FOENIX-CCA3 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

PFS: defined as the time from date of randomization to the date of documentation of disease progression by ICR per RECIST (version 1.1, 2009) or date of death, whichever comes first.

Secondary outcome measures

DCR

ORR

+2 more

FOENIX-CCA3 Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: TAS-120Experimental Treatment1 Intervention

TAS-120 tablets, oral; 21-day cycle

Group II: Cisplatin/GemcitabineActive Control1 Intervention

• On Days 1 and 8 of a 21-day cycle, patients will receive: Cisplatin 25 mg/m2 in 1000 mL 0.9% saline by intravenous (I.V.) infusion over 1 hour, followed by 500 mL 0.9% saline over 30 minutes; and Gemcitabine 1000 mg/m2 in 250-500 mL 0.9% saline by I.V. infusion over 30 minutes, beginning after completion of the cisplatin and saline infusions.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Taiho Oncology, Inc.Lead Sponsor

66 Previous Clinical Trials

11,368 Total Patients Enrolled

5 Trials studying Cholangiocarcinoma

599 Patients Enrolled for Cholangiocarcinoma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the Federal Drug Administration's stance on TAS-120?

"TAS-120 was given a score of 3 by our team at Power, denoting that while this drug is still in Phase 3 trials, there is evidence both for efficacy and safety from multiple rounds of testing."

Answered by AI

What is the current body of research on TAS-120?

"TAS-120 is being researched in 1017 ongoing trials, with 348 of those research projects at Phase 3. Out of the 53008 locations conducting clinical trials for TAS-120, several are based in Shanghai."

Answered by AI

How many individuals are enrolled in this research project?

"As noted by the sponsor, Taiho Oncology, Inc., a total of 216 individuals are needed to fill the clinical trial's requirements. The study will be conducted from multiple sites including Medical College of Wisconsin - Froedtert Hospital in Milwaukee, Wisconsin and Medical Oncology Associates, PS - Summit Cancer Centers in Spokane, Washington."

Answered by AI

What are the researchers looking to learn from this clinical trial?

"The primary outcome of this study, which will be evaluated over the course of 12 months, is progression-free survival (PFS). PFS is defined as the time from date of randomization to the date of documentation of disease progression by ICR per RECIST (version 1.1, 2009) or date of death, whichever comes first. Secondary outcomes include disease control rate (DCR), overall survival (OS), and objective response rate (ORR)."

Answered by AI

What is the primary purpose of TAS-120?

"TAS-120, while most commonly used to treat neoplasm metastasis, can also be given as treatment for other conditions such as urinary bladder cancer, advanced testicular cancer, and small cell lung cancer (sclc)."

Answered by AI

In how many states is this trial currently taking place?

"Currently, patients are being enrolled at the Medical College of Wisconsin - Froedtert Hospital in Milwaukee, Wisconsin, Medical Oncology Associates, PS - Summit Cancer Centers in Spokane, Washington and University of Virginia cancer center in Charlottesville. Additionally, there are 7 other sites across America recruiting for this trial."

Answered by AI

Are there any available slots for participants in this research project?

"Yes, according to the information available on clinicaltrials.gov, this study is still looking for patients to enroll. The posting date was March 1st 2020 and the most recent update was on August 4th 2022. A total of 216 individuals are needed for the trial which is being conducted at 7 locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Futibatinib Versus Gemcitabine-Cisplatin Chemotherapy as First-Line Treatment of Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements

2020. "Futibatinib Versus Gemcitabine-Cisplatin Chemotherapy as First-Line Treatment of Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04093362.

All > Intrahepatic Cholangiocarcinoma > Bile Duct Cancer