Pemigatinib In Subjects With Adenosquamous Carcinoma Of The Pancreas

Study Overview

Pemigatinib in Subjects With Adenosquamous Carcinoma of the Pancreas

The purpose of this research is to determine the benefit of pemigatinib in patients with advanced metastatic or surgically unresectable adenosquamous carcinoma of the pancreas who have progressed on previous therapy.

N/A

Pancreas Cancer

DRUG: Pemigatinib 4.5 MG

Incyte-54828-19-05

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2022-01-05	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2023-06-29
First Submitted that Met QC Criteria 2022-01-18	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2023-07-03
First Posted (ACTUAL) 2022-01-31	Results First Posted N/A	Last Verified 2023-06

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Pemigatinib Participants will be provided with a bottle of pemigatinib tablets on Day 1 of each cycle (one cycle = 21 days). A bottle contains 4.5 mg X 42 tablets total. Each pemigatinib bottle is sufficient for one cycle. Resupply will be provided as necessary on Da	DRUG: Pemigatinib 4.5 MG Pemigatinib 4.5 mg tablets taken 3 times per day [daily dose of 13.5 mg (3 tablets)] for 14 consecutive days followed by 7 days off medication in 21-day cycles Doses will be self-administered at home. Participants will be instructed to take study medicat

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Pemigatinib

Participants will be provided with a bottle of pemigatinib tablets on Day 1 of each cycle (one cycle = 21 days). A bottle contains 4.5 mg X 42 tablets total. Each pemigatinib bottle is sufficient for one cycle. Resupply will be provided as necessary on Da

DRUG: Pemigatinib 4.5 MG

Pemigatinib 4.5 mg tablets taken 3 times per day [daily dose of 13.5 mg (3 tablets)] for 14 consecutive days followed by 7 days off medication in 21-day cycles Doses will be self-administered at home. Participants will be instructed to take study medicat

Primary Outcome Measures	Measure Description	Time Frame
Overall response rate of pemigatinib	Overall response rate of pemigatinib in patients with advanced metastatic or surgically unresectable ASCP who have progressed on previous therapy	Initiation of study treatment up to 12 cycles (each cycle is 21 days)

Secondary Outcome Measures	Measure Description	Time Frame
Progression free survival (PFS)	To determine progression free survival (PFS)	Initiation of study treatment up to study completion, up to 2 years
Overall survival (OS)	To determine overall survival (OS)	Initiation of study treatment up to study completion, up to 2 years
Number of participants with treatment-related adverse events as assessed by CTCAE V4.0	To determine the overall safety (medical risk to the subject) and tolerability (the degree to which adverse effects can be tolerated by the subject) of pemigatinib in patients with advanced metastatic or surgically unresectable ASCP who have progressed on previous therapy	Initiation of study treatment up to 12 cycles (each cycle is 21 days)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Age ≥ 18 years of age; male or female
Capable of providing informed consent and complying with trial procedures.
Histologically or cytologically confirmed adenosquamous carcinoma of the pancreas (ASCP)
Metastatic or unresectable ASCP patients who have progressed on at least one line of therapy
FGFR gene fusion, mutation, or rearrangement as determined by standard CLIA-certified FDA-approved genomic panel (e.g. Ashion, Caris, FoundationOne etc.).
Radiographically measurable or evaluable disease according to RECIST 1.1 criteria.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Life expectancy ≥ 12 weeks.
Females of child-bearing potential (defined as a sexually mature woman who (1) has not undergone hysterectomy [the surgical removal of the uterus] or bilateral oophorectomy [the surgical removal of both ovaries] or (2) has not been naturally postmenopausal for at least 24 consecutive months [i.e., has had menses at any time during the preceding 24 consecutive months]) must:

from heterosexual contact (which must be reviewed on a monthly basis), or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting study treatment (including dose interruptions), and while on study treatment and for 1 week following discontinuation from study treatment ;and, 2. Have a negative serum pregnancy test (β -hCG) result at screening and agree to ongoing pregnancy testing during the course of the study, and at the end of study participation. This applies even if the subject practices true abstinence
from heterosexual contact.
Male subjects must practice true abstinence
or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for 1 week following discontinuation from study treatment, even if he has undergone a successful vasectomy.

Patients that have received prior treatment with a selective FGFR inhibitor
History of and/or current evidence of ectopic mineralization/calcification, including but not limited to soft tissue, kidneys, intestine, myocardia, or lung, excepting calcified lymph nodes and asymptomatic arterial or cartilage/tendon calcifications.
Current evidence of clinically significant corneal or retinal disorder confirmed by ophthalmologic examination.
Use of any potent CYP3A4 inhibitors or inducers within 14 days or 5 half-lives, whichever is shorter, before the first dose of study drug. Topical ketoconazole will be allowed.
Exposure to any therapeutic or investigational agent(s) within 3 weeks prior to initiation of study treatment.
Major surgery within 4 weeks prior to initiation of study treatment.
Any condition in the opinion of the principal investigator that might interfere with the patient's participation in the study or in the evaluation of the study results.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Incyte Corporation

Investigators

PRINCIPAL_INVESTIGATOR: Erkut Borazanci, MD, HonorHealth Research Institute

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Caregivers

Clinical Trial Record