Pemigatinib in Subjects With Adenosquamous Carcinoma of the Pancreas

Pancreas Cancer Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05216120
• Other study ID #: Incyte-54828-19-05
• Status: Withdrawn
• Phase: Phase 2
• Start date: June 14, 2022
• Est. completion date: August 31, 2025

Study information

• Verified date: June 2023
• Source: HonorHealth Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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 (ß -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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Adenosquamous
• Pancreas Cancer
• Pancreatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	HonorHealth Research Institute	Scottsdale	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
HonorHealth Research Institute	Incyte Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Progression free survival (PFS)	To determine progression free survival (PFS)	Initiation of study treatment up to study completion, up to 2 years
Secondary	Overall survival (OS)	To determine overall survival (OS)	Initiation of study treatment up to study completion, up to 2 years
Secondary	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)