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

Phase 2

Completed

• Conditions: Cholangiocarcinoma
• Interventions: Drug: Pemigatinib

• Registration Number: NCT04256980
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-20
• Study First Submitted QC: 2020-02-04
• Study First Posted: 2020-02-05
• Study Start: 2020-03-03
• Primary Completion: 2021-01-29
• Study Completion: 2023-08-31
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-29
• Last Update Posted: 2024-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

1. Men and women, aged 18 or older.
2. Histologically or cytologically confirmed cholangiocarcinoma which was considered to be advanced/metastatic or surgically unresectable by the investigator through image examination.
3. Radiographically measurable disease per RECIST v 1.1
4. Documentation of FGFR2 rearrangement.
5. Documented disease progression after at least 1 line of prior systemic therapy.
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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pemigatinib in patients with advanced/metastatic or surgically	Pemigatinib	Patients with advanced/metastatic or surgically unresectable cholangiocarcinoma

Primary Outcome Measures

Name	Time	Method
Objective response rate per RECIST 1.1	Every 6 weeks for the first 2 cycles and every 9 weeks thereafter through end of treatment, up to 24 months

Secondary Outcome Measures

Name	Time	Method
PFS（PFS= first dose to progressive disease or death）	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
DOR（DOR= time from the date of CR or PR until PD）	Every 6 weeks for the first 2 cycles and every 9 weeks thereafter through end of treatment, up to 24 months
DCR（DCR=CR + PR + stable disease）	Every 6 weeks for the first 2 cycles and every 9 weeks thereafter through end of treatment, up to 24 months
OS（OS= first dose to death of any cause）	Time from first treatment to the date of death from any cause, up to 24 months

Trial Locations

Locations (1)

Zhongshan Hospital Affiliated to Fudan University; 🇨🇳 Shanghai, Shanghai, China