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

Cholangiocarcinoma Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04256980
• Other study ID #: CIBI375A201
• Status: Completed
• Phase: Phase 2
• Start date: March 3, 2020
• Est. completion date: August 31, 2023

Study information

• Verified date: May 2024
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: August 31, 2023
• Est. primary completion date: January 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cholangiocarcinoma

Intervention

Drug:
• Pemigatinib
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

Locations

Country	Name	City	State
China	Zhongshan Hospital Affiliated to Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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