Pemigatinib in Treating Patients With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Including FGFR2 Rearrangement
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04256980|
Recruitment Status : Active, not recruiting
First Posted : February 5, 2020
Last Update Posted : October 4, 2022
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Cholangiocarcinoma||Drug: Pemigatinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||March 3, 2020|
|Actual Primary Completion Date :||June 27, 2022|
|Estimated Study Completion Date :||December 30, 2023|
Experimental: Pemigatinib in patients with advanced/metastatic or surgically
Patients with advanced/metastatic or surgically unresectable cholangiocarcinoma
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
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04256980
|Zhongshan Hospital Affiliated to Fudan University|
|Shanghai, Shanghai, China|
|Responsible Party:||Innovent Biologics (Suzhou) Co. Ltd.|
|Other Study ID Numbers:||
|First Posted:||February 5, 2020 Key Record Dates|
|Last Update Posted:||October 4, 2022|
|Last Verified:||October 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type