Pemigatinib in Subjects With Adenosquamous Carcinoma of the Pancreas

NCT ID: NCT05216120

Last Updated: 2023-07-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-14
• Study Completion Date: 2025-08-31

Brief Summary

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.

Conditions

Pancreas Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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 Day 1 of each cycle.

Group Type: EXPERIMENTAL

Pemigatinib 4.5 MG

Intervention Type: DRUG

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 medication at the same time each day, with or without food.

Interventions

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 medication at the same time each day, with or without food.

Intervention Type: DRUG

Other Intervention Names

Pemazyre

Eligibility Criteria

Inclusion Criteria

• 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:

1. Either commit to true abstinence* 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Incyte Corporation

INDUSTRY

Sponsor Role: collaborator

HonorHealth Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erkut Borazanci, MD

Role: PRINCIPAL_INVESTIGATOR

HonorHealth Research Institute

Locations

HonorHealth Research Institute

Scottsdale, Arizona, United States

Countries

United States

Other Identifiers

Incyte-54828-19-05

Identifier Type: -

Identifier Source: org_study_id