Back to resultsPemigatinib in Treating Patients With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Including FGFR2 Rearrangement
Primary Purpose
Cholangiocarcinoma
Status
Active
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Pemigatinib
Sponsored by
About this trial
This is an interventional treatment trial for Cholangiocarcinoma focused on measuring CCA, FGFR2, Pemigatinib
Eligibility Criteria
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.
Sites / Locations
- Zhongshan Hospital Affiliated to Fudan University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pemigatinib in patients with advanced/metastatic or surgically
Arm Description
Patients with advanced/metastatic or surgically unresectable cholangiocarcinoma
Outcomes
Primary Outcome Measures
Objective response rate per RECIST 1.1
Secondary Outcome Measures
PFS（PFS= first dose to progressive disease or death）
DOR（DOR= time from the date of CR or PR until PD）
DCR（DCR=CR + PR + stable disease）
OS（OS= first dose to death of any cause）
Full Information
NCT ID
NCT04256980
First Posted
January 20, 2020
Last Updated
October 3, 2022
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04256980
Brief Title
Pemigatinib in Treating Patients With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Including FGFR2 Rearrangement
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 3, 2020 (Actual)
Primary Completion Date
June 27, 2022 (Actual)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholangiocarcinoma
Keywords
CCA, FGFR2, Pemigatinib
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pemigatinib in patients with advanced/metastatic or surgically
Arm Type
Experimental
Arm Description
Patients with advanced/metastatic or surgically unresectable cholangiocarcinoma
Intervention Type
Drug
Intervention Name(s)
Pemigatinib
Intervention Description
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 Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Zhongshan Hospital Affiliated to Fudan University
City
Shanghai
State/Province
Shanghai
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pemigatinib in Treating Patients With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Including FGFR2 Rearrangement
We'll reach out to this number within 24 hrs