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Pemigatinib in Subjects With Adenosquamous Carcinoma of the Pancreas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05216120
Recruitment Status : Recruiting
First Posted : January 31, 2022
Last Update Posted : August 10, 2022
Sponsor:
Collaborator:
Incyte Corporation
Information provided by (Responsible Party):
HonorHealth Research Institute

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pancreas Cancer Drug: Pemigatinib 4.5 MG Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Pemigatinib in Subjects With Advanced Metastatic or Surgically Unresectable Adenosquamous Carcinoma of the Pancreas (ASCP) Who Have Progressed On Previous Therapy
Actual Study Start Date : June 14, 2022
Estimated Primary Completion Date : August 31, 2024
Estimated Study Completion Date : August 31, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Pemigatinib

Arms and Interventions
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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 Day 1 of each cycle.
 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 medication at the same time each day, with or without food.

Other Name: Pemazyre


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


Secondary Outcome Measures :
  1. Progression free survival (PFS) [ Time Frame: Initiation of study treatment up to study completion, up to 2 years ]
    To determine progression free survival (PFS)

  2. Overall survival (OS) [ Time Frame: Initiation of study treatment up to study completion, up to 2 years ]
    To determine overall survival (OS)

  3. Number of participants with treatment-related adverse events as assessed by CTCAE V4.0 [ Time Frame: Initiation of study treatment up to 12 cycles (each cycle is 21 days) ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05216120


Contacts
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Contact: Erkut Borazanci, MD 480-323-1364 clinicaltrials@honorhealth.com

Locations
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United States, Arizona
HonorHealth Research Institute Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Joyce Schaffer, RN, MSN, AOCNS    480-323-1364    clinicaltrials@honorhealth.com   
Contact: Andrea House    480-323-1364    clinicaltrials@honorhealth.com   
Sponsors and Collaborators
HonorHealth Research Institute
Incyte Corporation
Investigators
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Principal Investigator: Erkut Borazanci, MD HonorHealth Research Institute
More Information
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Responsible Party: HonorHealth Research Institute
ClinicalTrials.gov Identifier: NCT05216120    
Other Study ID Numbers: Incyte-54828-19-05
First Posted: January 31, 2022    Key Record Dates
Last Update Posted: August 10, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by HonorHealth Research Institute:
pancreatic cancer
adenosquamous carcinoma of the pancreas
ASCP
phase II
Additional relevant MeSH terms:
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Carcinoma
Pancreatic Neoplasms
Carcinoma, Adenosquamous
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
 Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Neoplasms, Complex and Mixed