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COHORT 2: EXPANSION PHASE 1B COHORT 2 MTD/RP2D PEMIGATINIB + AFATINIB FGFR INHIBITOR-PRETREATED for Bile Duct Cancer
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
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Frequently Asked Questions
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."
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."
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"
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