Solid TumorsPhase 1NCT03235570
A Safety and Tolerability Study of Pemigatinib in Japanese Subjects With Advanced Malignancies - (FIGHT-102)
A Phase 1 study testing Pemigatinib in people with Solid Tumors, run by Incyte Corporation at 12 sites in Japan.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of pemigatinib in Japanese subjects with advanced malignancies. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- Pemigatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 12 sitesJapan
- Study dates
- 1 Aug 2017to 4 Mar 2020
- Phase
- Phase 1
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First generation Japanese; subject was born in Japan and has not lived outside of Japan for a total of > 10 years and subject can trace maternal and paternal Japanese ancestry.
- Part 1: Any histologically confirmed advanced solid tumor malignancy. Subjects enrolled at a lower dose level expansion cohort are required to have documented FGF/FGFR alterations and baseline and on-treatment tumor biopsy for testing of biomarkers.
- Part 2: Any histologically confirmed advanced solid tumor malignancy with a FGF/FGFR alteration
- Advanced or metastatic and recurrent cancer where an appropriate treatment option is not available.
- Life expectancy > 12 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance status: Part 1: 0 or 1; Part 2: 0, 1, or 2.
- Genomic testing is mandatory for all enrolled subjects. Archival tumor specimen of at least 7 slides or willingness to undergo a pretreatment tumor biopsy to provide a tumor block or at least 7 unstained slides. Archival tumor biopsies are acceptable at baseline and should be no more than 2 years old (preferably less than 1 year old and collected since the completion of the last treatment); subjects with samples older than 2 years old and/or with sequencing report from the central laboratory require approval from the sponsor medical monitor for exemption from tumor biopsy or tumor sample requirement.
Who cannot join
- Treatment with other investigational study drug for any indication for any reason, or receipt of anticancer medications within 21 days or 5 half-lives (whichever is longer) before first dose of study drug (6 weeks for mitomycin-C or nitrosoureas, 7 days for tyrosine kinase inhibitors).
- Prior receipt of a selective FGFR inhibitor.
- Laboratory and medical history parameters outside Protocol-defined range.
- History 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 calcification.
- Current evidence of corneal disorder/keratopathy including but not limited to bullous/band keratopathy, corneal abrasion, inflammation/ulceration, keratoconjunctivitis, confirmed by ophthalmologic examination.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Japan12 sites
Aichi Cancer Center Hospital
Aichi, 464-8681
Chiba Cancer Center
Chiba, 260-8717
National Cancer Central Hospital East
Chiba, 277-8577
Kyusyu Cancer Center
Fukuoka, 811-1395
Kanazawa University Hospital
Ishikawa, 920-8641
Kanagawa Cancer Center
Kanagawa, 241-8515
Osaka International Cancer Institute
Osaka, 541-8567
Saitama Cancer Center
Saitama, 362-0806
Hokkaido Cancer Center
Sapporo, 003-0804
Shizuoka Cancer Center
Shizuoka, 411-8777
National Cancer Central Hospital
Tokyo, 104-0045
JFCR Ariake Hospital
Tokyo, 135-8550
About this study
Official title: A Phase 1, Open-Label, Dose-Escalation, Dose-Expansion, Safety and Tolerability Study of Pemigatinib in Japanese Subjects With Advanced Malignancies - (FIGHT-102)
The purpose of this study is to evaluate the safety and tolerability of pemigatinib in Japanese subjects with advanced malignancies.
- Conditions
- Solid Tumors
- Being tested
- Pemigatinib
- Keywords
- Solid tumor, malignancy, fibroblast growth factor receptor (FGFR), fibroblast growth factor (FGF)/FGFR alteration
- Medical subject headings
- Neoplasms, Acrocephalosyndactylia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PemigatinibDrug
Also called INCB054828
Pemigatinib at the protocol-defined dose administered once daily.
| Study group | Role | What they receive |
|---|---|---|
| Pemigatinib | Experimental | Part 1 is an open-label dose-escalation design based on observing each dose level for a period of 21 days. Part 2 will evaluate the recommended dose determined in Part 1. Receives: Drug: Pemigatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability assessed by monitoring frequency, duration, and severity of adverse events (AEs)
An AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a subject provides informed consent.
Measured: Baseline through 30 days after end of treatment, up to approximately 16 months.
Secondary outcomes (3)
Overall response rate in subjects with measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Defined as proportion of subjects who meet the response criteria (complete response + partial response) as appropriate for the tumor type.
Measured: Baseline and Day 15 of every third treatment cycle, up to approximately 6 months
Pharmacodynamics of pemigatinib assessed by changes in serum phosphorus level
Analyzed to look for differences that may be associated with response or safety as well as significant changes associated with treatment.
Measured: Baseline and protocol-defined timepoints throughout the treatment period, up to approximately 6 months
Observed Plasma Concentration of pemigatinib
PK parameters will be calculated from the blood plasma concentrations of pemigatinib using standard noncompartmental (model independent) PK methods.
Measured: During the first cycle, up to Day 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2017
- Study start1 Aug 2017
- Primary completion4 Mar 2020
- Study completion4 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ekaterine Asatiani, MD, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03235570
- Sponsor's protocol ID
- INCB 54828-102
- Status last verified
- May 2020
- First submitted
- 27 Jul 2017
- Last updated
- 29 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Dose-Escalation, Dose-Expansion, Safety and Tolerability Study of Pemigatinib in Japanese Subjects With Advanced Malignancies - (FIGHT-102)
- ClinicalTrials.gov ID
- NCT03235570
- Acronym / sponsor ID
- INCB 54828-102
- Conditions
- Solid Tumors
- Keywords
- Solid tumor, malignancy, fibroblast growth factor receptor (FGFR), fibroblast growth factor (FGF)/FGFR alteration
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 4 Mar 2020 (actual)
- Study completion
- 4 Mar 2020 (actual)
- First posted
- 1 Aug 2017 (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 study is to evaluate the safety and tolerability of pemigatinib in Japanese subjects with advanced malignancies.
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: PemigatinibPart 1 is an open-label dose-escalation design based on observing each dose level for a period of 21 days. Part 2 will evaluate the recommended dose determined in Part 1. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- First generation Japanese; subject was born in Japan and has not lived outside of Japan for a total of > 10 years and subject can trace maternal and paternal Japanese ancestry.
- Part 1: Any histologically confirmed advanced solid tumor malignancy. Subjects enrolled at a lower dose level expansion cohort are required to have documented FGF/FGFR alterations and baseline and on-treatment tumor biopsy for testing of biomarkers.
- Part 2: Any histologically confirmed advanced solid tumor malignancy with a FGF/FGFR alteration
- Advanced or metastatic and recurrent cancer where an appropriate treatment option is not available.
- Life expectancy > 12 weeks.
Key exclusion criteria (5 listed)
- Treatment with other investigational study drug for any indication for any reason, or receipt of anticancer medications within 21 days or 5 half-lives (whichever is longer) before first dose of study drug (6 weeks for mitomycin-C or nitrosoureas, 7 days for tyrosine kinase inhibitors).
- Prior receipt of a selective FGFR inhibitor.
- Laboratory and medical history parameters outside Protocol-defined range.
- History 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 calcification.
- Current evidence of corneal disorder/keratopathy including but not limited to bullous/band keratopathy, corneal abrasion, inflammation/ulceration, keratoconjunctivitis, confirmed by ophthalmologic examination.
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 |
|---|---|---|
| PemigatinibAlso: INCB054828Pemigatinib at the protocol-defined dose administered once daily. | Drug | Pemigatinib |
Primary outcome
Safety and tolerability assessed by monitoring frequency, duration, and severity of adverse events (AEs)
Time frame: Baseline through 30 days after end of treatment, up to approximately 16 months.
An AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a subject provides informed consent.
3 secondary outcomes
Overall response rate in subjects with measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: Baseline and Day 15 of every third treatment cycle, up to approximately 6 months
Pharmacodynamics of pemigatinib assessed by changes in serum phosphorus level
Time frame: Baseline and protocol-defined timepoints throughout the treatment period, up to approximately 6 months
Observed Plasma Concentration of pemigatinib
Time frame: During the first cycle, up to Day 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2020.
- 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.
Ekaterine Asatiani, MD study director
Incyte Corporation
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pemigatinib in people with Solid Tumors, run by Incyte Corporation at 12 sites in Japan.
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 7 inclusion and 5 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: finished, as of the sponsor's last update on 29 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Japan. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety and tolerability assessed by monitoring frequency, duration, and severity of adverse events (AEs) (time frame: Baseline through 30 days after end of treatment, up to approximately 16 months.). 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 29 May 2020.