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Tyrosine Kinase Inhibitor

Afatinib + Pemigatinib for Solid Tumors

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

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 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
~250

Find a Location

Who is running the clinical trial?

Boehringer IngelheimIndustry Sponsor
2,516 Previous Clinical Trials
11,347,276 Total Patients Enrolled
Incyte CorporationIndustry Sponsor
373 Previous Clinical Trials
55,709 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
2,955 Previous Clinical Trials
13,212,608 Total Patients Enrolled
~47 spots leftby Dec 2024