Pemigatinib in Treating Patients With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Including FGFR2 Rearrangement
Study Details
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Pemigatinib in patients with advanced/metastatic or surgically Patients with advanced/metastatic or surgically unresectable cholangiocarcinoma |
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
|
Outcome Measures
Primary Outcome Measures
- 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
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Men and women, aged 18 or older.
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Histologically or cytologically confirmed cholangiocarcinoma which was considered to be advanced/metastatic or surgically unresectable by the investigator through image examination.
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Radiographically measurable disease per RECIST v 1.1
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Documentation of FGFR2 rearrangement.
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Documented disease progression after at least 1 line of prior systemic therapy.
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ECOG performance status of 0~1.
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Life expectancy ≥12 weeks.
Exclusion Criteria:
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Prior receipt of a selective FGFR inhibitor.
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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).
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Currently evidence of clinically significant corneal or retinal disorder confirmed by ophthalmologic examination.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Zhongshan Hospital Affiliated to Fudan University | Shanghai | Shanghai | China |
Sponsors and Collaborators
- Innovent Biologics (Suzhou) Co. Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CIBI375A201