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Tyrosine Kinase Inhibitor

COHORT 1: EXPANSION PHASE 1B COHORT 1 MTD/RP2D PEMIGATINIB + AFATINIB FGFR INHIBITOR-NAIVE for Bile Duct Cancer

Phase 1

Recruiting

Led By Andreas Varkaris, MD

Research Sponsored by Massachusetts General Hospital

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 baseline, every 9 weeks during treatment and off study up to 1 year

Awards & highlights

Study Summary

This trial is testing if a combination of two drugs, Afatinib and Pemigatinib, is safe and effective for treating certain types of advanced solid tumors with specific genetic mutations. The study

Who is the study for?

This trial is for individuals with advanced solid tumors that can't be removed by surgery or have spread (metastatic), and whose tumors have specific genetic alterations called FGFR. The exact eligibility criteria are not provided, but typically participants must meet certain health standards to ensure safety.Check my eligibility

What is being tested?

The study is testing the combination of two drugs, Afatinib and Pemigatinib, to see if they're safe and effective against advanced solid tumors with FGFR alterations. It also aims to find the highest doses patients can take without severe side effects.See study design

What are the potential side effects?

While specific side effects aren't listed here, common ones for cancer treatments like Afatinib and Pemigatinib may include diarrhea, skin issues, mouth sores, loss of appetite, fatigue, nail changes, and potential liver problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, every 9 weeks during treatment and off study up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, every 9 weeks during treatment and off study up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, every 9 weeks during treatment and off study up to 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

Maximum tolerated dose (MTD)

Objective response rate (ORR)

Secondary outcome measures

Best Overall Response

Disease Control Rate

Duration of Response

+6 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: DOSE ESCALATION PHASE 1A PEMIGATINIB + AFATINIBExperimental Treatment2 Interventions

In the phase 1a dose escalation study participants with FGFR-altered refractory advanced solid tumors will be enrolled. This research study involves the study drugs Afatinib and Pemigatinib.

Group II: COHORT 2: EXPANSION PHASE 1B COHORT 2 MTD/RP2D PEMIGATINIB + AFATINIB FGFR INHIBITOR-PRETREATEDExperimental Treatment2 Interventions

In the phase Ib dose expansion study, patients with FGFR-altered cholangiocarcinoma will be recruited into 2 cohorts: FGFR inhibitor-naïve cholangiocarcinoma and FGFR-inhibitor-pretreated and resistant cholangiocarcinoma. Cohort 2 will enroll patients with FGFR-inhibitor-pretreated and resistant cholangiocarcinoma. This research study involves the study drugs Afatinib and Pemigatinib.

Group III: COHORT 1: EXPANSION PHASE 1B COHORT 1 MTD/RP2D PEMIGATINIB + AFATINIB FGFR INHIBITOR-NAIVEExperimental Treatment2 Interventions

In the phase Ib dose expansion study, patients with FGFR-altered cholangiocarcinoma will be recruited into 2 cohorts: FGFR inhibitor-naïve cholangiocarcinoma and FGFR-inhibitor-pretreated and resistant cholangiocarcinoma. Cohort 1 will enroll patients with FGFR inhibitor-naïve cholangiocarcinoma. This research study involves the study drugs Afatinib and Pemigatinib.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Afatinib

2016

Completed Phase 4

~2340

Pemigatinib

2022

Completed Phase 2

~220

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Boehringer IngelheimIndustry Sponsor

2,507 Previous Clinical Trials

11,340,837 Total Patients Enrolled

Incyte CorporationIndustry Sponsor

365 Previous Clinical Trials

55,225 Total Patients Enrolled

Massachusetts General HospitalLead Sponsor

2,934 Previous Clinical Trials

13,198,511 Total Patients Enrolled

Frequently Asked Questions

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

Are patients currently able to enroll in this ongoing study?

"As per clinicaltrials.gov, recruitment for this trial is closed. The study was first listed on 1st July 2024 and last updated on 7th March 2024. Despite this trial being inactive, there are currently 2911 other trials open for participant enrollment."

Answered by AI

What are the risks associated with increasing the dosage of pemigatinib in combination with afatinib during phase 1A for patients?

"Based on our assessment, the safety rating for the combination of pemigatinib and afatinib in the dose escalation phase 1a trial is a 1. This indicates that as a Phase 1 study, there exists minimal data supporting both safety and efficacy."

Answered by AI

What is the primary objective of this research endeavor?

"As per the sponsor, Boehringer Ingelheim, this trial's primary endpoint is the Objective Response Rate (ORR) to be evaluated within a 21-day timeframe. Secondary outcomes will encompass determining Maximum Plasma Concentration [Cmax] and C trough levels of pemigatinib and afatinib to characterize their pharmacokinetic properties. Additionally, molecular markers linked to response such as circulating biomarkers, tumor DNA in circulation, and tissue-based biomarkers will be scrutinized along with assessing Duration of Response from initial complete or partial response confirmation by RECIST v1.1 until progression disease assessment using RECIST v1.1"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pemigatinib + Afatinib in Advanced Refractory Solid Tumors

Andreas Varkaris, MD, PhD 2024. "Pemigatinib + Afatinib in Advanced Refractory Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06302621.

All > Intrahepatic Cholangiocarcinoma > Cholangiocarcinoma