Clinical trial NCT05216120: Pemigatinib in Subjects With Adenosquamous Carcinoma of the Pancreas
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Pancreas Cancer
Keywords: pancreatic cancer
adenosquamous carcinoma of the pancreas
ASCP
phase II
Lead sponsor: HonorHealth Research Institute
Sponsor class: OTHER
Collaborators: name: Incyte Corporation
First posted: 2022-01-31
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Overall response rate of pemigatinib
timeFrame: Initiation of study treatment up to 12 cycles (each cycle is 21 days)
Secondary outcomes:
measure: Progression free survival (PFS)
timeFrame: Initiation of study treatment up to study completion, up to 2 years
measure: Overall survival (OS)
timeFrame: Initiation of study treatment up to study completion, up to 2 years
measure: Number of participants with treatment-related adverse events as assessed by CTCAE V4.0
timeFrame: Initiation of study treatment up to 12 cycles (each cycle is 21 days)
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: HonorHealth Research Institute
state: Arizona
Study officials:
affiliation: HonorHealth Research Institute
name: Erkut Borazanci, MD
role: PRINCIPAL_INVESTIGATOR
References: