Pancreas CancerPhase 2NCT05216120
Pemigatinib in Subjects With Adenosquamous Carcinoma of the Pancreas
A Phase 2 study testing Pemigatinib 4.5 MG in people with Pancreas Cancer, run by HonorHealth Research Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Pancreas Cancer
- What is being tested?
- Pemigatinib 4.5 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2022to 31 Aug 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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:
- 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,
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
HonorHealth Research Institute
Scottsdale, Arizona, 85258
About this study
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
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
- Being tested
- Pemigatinib 4.5 MG
- Keywords
- pancreatic cancer, adenosquamous carcinoma of the pancreas, ASCP, phase II
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pemigatinib 4.5 MGDrug
Also called Pemazyre
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.
| Study group | Role | What they receive |
|---|---|---|
| Pemigatinib | Experimental | 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. Receives: Drug: Pemigatinib 4.5 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Initiation of study treatment up to 12 cycles (each cycle is 21 days)
Secondary outcomes (3)
Progression free survival (PFS)
To determine progression free survival (PFS)
Measured: Initiation of study treatment up to study completion, up to 2 years
Overall survival (OS)
To determine overall survival (OS)
Measured: Initiation of study treatment up to study completion, up to 2 years
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
Measured: Initiation of study treatment up to 12 cycles (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start14 Jun 2022
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2025 (estimated)
Why it stopped: enrollment challenges
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- HonorHealth Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Incyte Corporation
- Responsible party
- Sponsor
- Investigators
- Erkut Borazanci, MD, Principal investigator, HonorHealth Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05216120
- Sponsor's protocol ID
- Incyte-54828-19-05
- Status last verified
- Jun 2023
- First submitted
- 5 Jan 2022
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05216120
- Acronym / sponsor ID
- Incyte-54828-19-05
- Conditions
- Pancreas Cancer
- Keywords
- pancreatic cancer, adenosquamous carcinoma of the pancreas, ASCP, phase II
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: enrollment challenges
- Enrolment
- 0 participants (actual)
- Lead sponsor
- HonorHealth Research InstituteUniversity, hospital or other
- Collaborators
- Incyte Corporation
- Study start
- 14 Jun 2022 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 31 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pemigatinib | Experimental | Drug: Pemigatinib 4.5 MGParticipants 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.).
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pemigatinib 4.5 MGAlso: PemazyrePemigatinib 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. | Drug | Pemigatinib |
Primary outcome
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
3 secondary outcomes
Progression free survival (PFS)
Time frame: Initiation of study treatment up to study completion, up to 2 years
Overall survival (OS)
Time frame: Initiation of study treatment up to study completion, up to 2 years
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)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erkut Borazanci, MD principal investigator
HonorHealth Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pemigatinib 4.5 MG in people with Pancreas Cancer, run by HonorHealth Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate of pemigatinib (time frame: Initiation of study treatment up to 12 cycles (each cycle is 21 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.