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NCT Number: NCT04256980

Pemigatinib in Treating Patients With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Including FGFR2 Rearrangement

This is a phase 2 study to investigate the efficacy and safety of Pemigatinib in treating patients with advanced/metastatic or surgically unresectable cholangiocarcinoma with FGFR2 rearrangement who have failed at least 1 previous therapy

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Key information

Conditions

Cholangiocarcinoma Adenocarcinoma Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Zhongshan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 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 cholangiocarcinoma which was considered to be advanced/metastatic or surgically unresectable by the investigator through image examination.
  • Radiographically measurable disease per RECIST v 1.1
  • Documentation of FGFR2 rearrangement.
  • Documented disease progression after at least 1 line of prior systemic therapy.
  • 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 at 9mg Or 13.5mg as a QD oral treatment on a 2-week-on therapy and 1-week-off therapy schedule

Primary outcomes

  1. Objective response rate per RECIST 1.1

    Time frame: Every 6 weeks for the first 2 cycles and every 9 weeks thereafter through end of treatment, up to 24 months

Secondary outcomes

  1. PFS（PFS= first dose to progressive disease or death）

    Time frame: Time from first treatment to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

  2. DOR（DOR= time from the date of CR or PR until PD）

    Time frame: Every 6 weeks for the first 2 cycles and every 9 weeks thereafter through end of treatment, up to 24 months

  3. DCR（DCR=CR + PR + stable disease）

    Time frame: Every 6 weeks for the first 2 cycles and every 9 weeks thereafter through end of treatment, up to 24 months

  4. OS（OS= first dose to death of any cause）

    Time frame: Time from first treatment to the date of death from any cause, up to 24 months

Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Registry information

Official study title

A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Including FGFR2 Rearrangement Who Failed at Least One Previous Therapy

Important dates

Study start
2020
Primary completion
2021
Study completion
2023
First posted
Feb 5, 2020
Registry last updated
May 30, 2024

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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