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NCT Number: NCT04258527

Phase 1 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.

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Key information

Conditions

Solid Tumor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cancer Hospital of Tianjin Medical University

Tianjin, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Pemigatinib

Drug

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.

Primary outcomes

  1. Maximum observed plasma concentration (Cmax) during the dosing interval and Cmin of Pemigatinib as monotherapy

    Time frame: Day 1 to Day 16

  2. Time to maximum plasma concentration (Tmax) of Pemigatinib as monotherapy

    Time frame: Day 1 to Day 16

  3. Area under the single-dose plasma concentration-time curve (AUC0-t) of Pemigatinib as monotherapy

    Time frame: Day 1 to Day 16

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Feb 6, 2020
Registry last updated
Jul 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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