Solid TumorPhase 1NCT04258527
Phase 1 Study of Pemigatinib in Patients With Advanced Malignancies With FGF/FGFR Alterations
A Phase 1 study testing Pemigatinib in people with Solid Tumor, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
This is a phase 1 study to investigate the characteristics of PK, PD and safety in subjects with advanced malignancies with FGF/FGFR alterations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- Pemigatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 26 Mar 2020to 8 Mar 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women, aged 18 or older.
- Histologically or cytologically confirmed malignancy which was considered to be surgically unresectable advanced, relapse or metastatic .
- Radiographically measurable disease per RECIST v 1.1
- Documentation of FGF/FGFR alteration..
- Documented disease progression after standard therapy ,or no standard therapy available.
- ECOG performance status of 0~1.
- Life expectancy ≥12 weeks
Who cannot join
- Prior receipt of a selective FGFR inhibitor.
- History of calcium and phosphate hemostasis disorder or systemic mineral imbalance with ectopic calcification of softy tissues ( exception: skin, kidney, tendons or vessels due to injury, disease, and aging, in the absence of systemic mineral imbalance).
- Currently 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label, Pharmacokinetic(PK), Pharmacodynamics(PD) and Safety Study of Pemigatinib in Patients With Advanced Malignancies With FGF/FGFR Alterations
This is a phase 1 study to investigate the characteristics of PK, PD and safety in subjects with advanced malignancies with FGF/FGFR alterations.
- Conditions
- Solid Tumor
- Being tested
- Pemigatinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PemigatinibDrug
Pemigatinib will be self-administered as at 13.5mg a QD oral treatment on a 2-week-on therapy and 1-week-off therapy schedule.
| Study group | Role | What they receive |
|---|---|---|
| Patients with advanced malignancies with FGF/FGFR alterations | Experimental | Not described Receives: Drug: Pemigatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax) during the dosing interval and Cmin of Pemigatinib as monotherapy
Measured: Day 1 to Day 16
Time to maximum plasma concentration (Tmax) of Pemigatinib as monotherapy
Measured: Day 1 to Day 16
Area under the single-dose plasma concentration-time curve (AUC0-t) of Pemigatinib as monotherapy
Measured: Day 1 to Day 16
Secondary outcomes (1)
Safety of pemigatinib as monotherapy as assessed by the frequency, duration, and severity of adverse events
Measured: From screening through 30-35 days after end of treatment, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start26 Mar 2020
- Primary completion2 Jul 2020
- Study completion8 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by Innovent Biologics (Suzhou) Co. Ltd.The 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04258527
- Sponsor's protocol ID
- CIBI375A101
- Status last verified
- Jul 2021
- First submitted
- 20 Jan 2020
- Last updated
- 23 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Deng T, Zhang L, Shi Y, Bai G, Pan Y, Shen A, Han X, Yang Z, Chen M, Zhou H, Luo Y, Zheng S, Ba Y. Pharmacokinetics, pharmacodynamics and efficacy of pemigatinib (a selective inhibitor of fibroblast growth factor receptor 1-3) monotherapy in Chinese patients with advanced solid tumors: a phase i clinical trial. Invest New Drugs. 2023 Dec;41(6):808-815. doi: 10.1007/s10637-023-01396-x. Epub 2023 Oct 27.
PubMed 37889382
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Pharmacokinetic(PK), Pharmacodynamics(PD) and Safety Study of Pemigatinib in Patients With Advanced Malignancies With FGF/FGFR Alterations
- ClinicalTrials.gov ID
- NCT04258527
- Acronym / sponsor ID
- CIBI375A101
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Mar 2020 (actual)
- Primary completion
- 2 Jul 2020 (actual)
- Study completion
- 8 Mar 2021 (actual)
- First posted
- 6 Feb 2020 (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.
This is a phase 1 study to investigate the characteristics of PK, PD and safety in subjects with advanced malignancies with FGF/FGFR alterations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with advanced malignancies with FGF/FGFR alterations | Experimental | Drug: Pemigatinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men and women, aged 18 or older.
- Histologically or cytologically confirmed malignancy which was considered to be surgically unresectable advanced, relapse or metastatic .
- Radiographically measurable disease per RECIST v 1.1
- Documentation of FGF/FGFR alteration..
- Documented disease progression after standard therapy ,or no standard therapy available.
Key exclusion criteria (4 listed)
- Prior receipt of a selective FGFR inhibitor.
- History of calcium and phosphate hemostasis disorder or systemic mineral imbalance with ectopic calcification of softy tissues ( exception: skin, kidney, tendons or vessels due to injury, disease, and aging, in the absence of systemic mineral imbalance).
- Currently 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
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 |
|---|---|---|
| PemigatinibPemigatinib will be self-administered as at 13.5mg a QD oral treatment on a 2-week-on therapy and 1-week-off therapy schedule. | Drug | Patients with advanced malignancies with FGF/FGFR alterations |
Primary outcome
Maximum observed plasma concentration (Cmax) during the dosing interval and Cmin of Pemigatinib as monotherapy
Time frame: Day 1 to Day 16
Time to maximum plasma concentration (Tmax) of Pemigatinib as monotherapy
Time frame: Day 1 to Day 16
Area under the single-dose plasma concentration-time curve (AUC0-t) of Pemigatinib as monotherapy
Time frame: Day 1 to Day 16
1 secondary outcome
Safety of pemigatinib as monotherapy as assessed by the frequency, duration, and severity of adverse events
Time frame: From screening through 30-35 days after end of treatment, up to 6 months
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 23 Jul 2021.
- Derived from this study: PubMed 37889382Deng T, Zhang L, Shi Y, Bai G, Pan Y, Shen A, Han X, Yang Z, Chen M, Zhou H, Luo Y, Zheng S, Ba Y. Pharmacokinetics, pharmacodynamics and efficacy of pemigatinib (a selective inhibitor of fibroblast growth factor receptor 1-3) monotherapy in Chinese patients with advanced solid tumors: a phase i clinical trial. Invest New Drugs. 2023 Dec;41(6):808-815. doi: 10.1007/s10637-023-01396-x. Epub 2023 Oct 27.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 Tumor, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
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 4 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 23 Jul 2021. 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 China. 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?
Maximum observed plasma concentration (Cmax) during the dosing interval and Cmin of Pemigatinib as monotherapy (time frame: Day 1 to Day 16). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04258527, which also lists 1 linked publication.
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 23 Jul 2021.