Pemigatinib in Subjects With Adenosquamous Carcinoma of the Pancreas

HonorHealth Research Institute

Status and phase: Withdrawn; Phase 2

Conditions: Pancreas Cancer

Treatments: Drug: Pemigatinib 4.5 MG

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05216120

Incyte-54828-19-05

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Pemigatinib

Experimental group

Description:

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.

Treatment:

Drug: Pemigatinib 4.5 MG