Phase 1 Study of Pemigatinib in Patients With Advanced Malignancies With FGF/FGFR Alterations

A Phase 1, Open-Label, Pharmacokinetic(PK), Pharmacodynamics(PD) and Safety Study of Pemigatinib in Patients With Advanced Malignancies With FGF/FGFR Alterations

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04258527

Enrollment

Registered

2020-02-06

Start date

2020-03-26

Completion date

2021-03-08

Last updated

2021-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Tumor

Brief 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.

Interventions

DRUGPemigatinib

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 design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Men and women, aged 18 or older. 2. Histologically or cytologically confirmed malignancy which was considered to be surgically unresectable advanced, relapse or metastatic . 3. Radiographically measurable disease per RECIST v 1.1 4. Documentation of FGF/FGFR alteration.. 5. Documented disease progression after standard therapy ,or no standard therapy available. 6. ECOG performance status of 0\ 1. 7. Life expectancy ≥12 weeks

Exclusion criteria

1. Prior receipt of a selective FGFR inhibitor. 2. 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). 3. Currently evidence of clinically significant corneal or retinal disorder confirmed by ophthalmologic examination. 4. 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

Design outcomes

Primary

Measure	Time frame
Maximum observed plasma concentration (Cmax) during the dosing interval and Cmin of Pemigatinib as monotherapy	Day 1 to Day 16
Time to maximum plasma concentration (Tmax) of Pemigatinib as monotherapy	Day 1 to Day 16
Area under the single-dose plasma concentration-time curve (AUC0-t) of Pemigatinib as monotherapy	Day 1 to Day 16

Secondary

Measure	Time frame
Safety of pemigatinib as monotherapy as assessed by the frequency, duration, and severity of adverse events	From screening through 30-35 days after end of treatment, up to 6 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026