What side effects are associated with this type of intervention?

Common treatments for bile duct cancer, including systemic chemotherapy (e.g., gemcitabine plus cisplatin) and FGFR inhibitors like Tinengotinib, often result in side effects such as nausea, vomiting, diarrhea, and fatigue. Liver function abnormalities are also observed. FGFR inhibitors specifically may cause hyperphosphatemia and ocular disorders.

What prior FDA approvals exist?

The FDA has approved several treatments for bile duct cancer, including targeted therapies and chemotherapy. One notable FGFR inhibitor approved for bile duct cancer is pemigatinib, which is used for patients with FGFR2 gene fusions or rearrangements. Other treatments include gemcitabine and cisplatin, which are commonly used chemotherapy agents for this type of cancer. These treatments aim to manage the disease and improve patient outcomes.

What other types of research exist?

Promising alternatives to Tinengotinib for bile duct cancer patients include: 1) EGFR kinase inhibitors for patients with response-predicting EGFR mutations, 2) systemic chemotherapy options such as gemcitabine plus cisplatin, and 3) novel targeted therapies like Selpercatinib for RET-altered cancers. Additionally, ongoing research into other FGFR inhibitors and combination therapies may provide new options.

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Tinengotinib for Bile Duct Cancer (FIRST-308 Trial)

Phase 3

Recruiting

Led By Milind Javle, MD

Research Sponsored by TransThera Sciences (Nanjing), Inc.

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 from first study drug administration until the date of death from any cause, assessed up to 24 months.

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing an oral medication called Tinengotinib for patients with a specific type of bile duct cancer that has not responded to other treatments. The medication works by blocking a protein that helps cancer cells grow. The goal is to see if Tinengotinib can slow down or stop the cancer in these patients.

Who is the study for?

This trial is for adults over 18 with bile duct cancer that can't be surgically removed or has spread, and have specific FGFR2 gene changes. Participants must have tried one chemotherapy and one approved FGFR inhibitor but not more than that. They shouldn't have worsening brain metastases, be on other cancer treatments, or have another progressing cancer.

What is being tested?

The study compares the effectiveness of a new drug called Tinengotinib (at two different doses) against treatments chosen by physicians in patients with cholangiocarcinoma who haven’t responded to previous therapies. It's a randomized controlled trial meaning participants are randomly assigned to receive either the experimental drug or standard treatment.

What are the potential side effects?

While specific side effects of Tinengotinib aren't listed here, similar drugs often cause diarrhea, mouth sores, fatigue, nail changes, high blood pressure and may affect liver function. Side effects vary from person to person.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first study drug administration until the date of death from any cause, assessed up to 24 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from first study drug administration until the date of death from any cause, assessed up to 24 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first study drug administration until the date of death from any cause, assessed up to 24 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

Part A: Incidence, duration, and severity of adverse events (AEs)

Part B: PFS by BICR

Secondary study objectives

Part A: DOR by Investigator

Part A: ORR by Investigator

Part B: Duration of Response (DOR) by BICR and by Investigator

+3 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Tinengotinib 8 mg QDExperimental Treatment1 Intervention

Tinengotinib will be administered in 28-day cycles.

Group II: Tinengotinib 10 mg QDExperimental Treatment1 Intervention

Tinengotinib will be administered in 28-day cycles.

Group III: Physician's ChoiceActive Control1 Intervention

Physician's Choice treatments include FOLFOX or FOLFIRI

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for bile duct cancer include targeted therapies and chemotherapy. FGFR inhibitors like Tinengotinib block the fibroblast growth factor receptor pathway, which is often altered in cholangiocarcinoma, thereby inhibiting tumor growth. BRAF inhibitors (dabrafenib) and MEK inhibitors (trametinib) target the BRAF V600E mutation and the downstream MEK pathway, respectively, leading to reduced tumor cell proliferation. EGFR inhibitors (erlotinib) block the epidermal growth factor receptor, which is involved in cell growth and survival. Chemotherapy regimens, such as gemcitabine and cisplatin, work by damaging the DNA of cancer cells, preventing their replication. These treatments are crucial for bile duct cancer patients as they offer personalized and effective options to manage the disease, potentially improving survival and quality of life.

EGFR Target Therapy Combined with Gemox for Advanced Biliary Tract Cancers: a Meta-analysis based on RCTs.Dramatic response to dabrafenib and trametinib combination in a BRAF V600E-mutated cholangiocarcinoma: implementation of a molecular tumour board and next-generation sequencing for personalized medicine.Gemcitabine and oxaliplatin with or without erlotinib in advanced biliary-tract cancer: a multicentre, open-label, randomised, phase 3 study.