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

NCT04256980 | Completed Phase 2 DMC

• 1 other identifier: CIBI375A201
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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

Conditions

Cholangiocarcinoma

Keywords

CCA; FGFR2; Pemigatinib

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (1)

Pemigatinib in patients with advanced/metastatic or surgically

EXPERIMENTAL

Patients with advanced/metastatic or surgically unresectable cholangiocarcinoma

Drug: Pemigatinib

Interventions

Pemigatinib DRUG

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

Pemigatinib in patients with advanced/metastatic or surgically

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (1)

Zhongshan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, China

Location

Related Publications (1)

• Shi GM, Huang XY, Wen TF, Song TQ, Kuang M, Mou HB, Bao LQ, Zhao HT, Zhao H, Feng XL, Zhang BX, Peng T, Zhang YB, Li XC, Yu HS, Cao Y, Liu LX, Zhang T, Wang WL, Ran JH, Liu YB, Gong W, Chen MX, Cao L, Luo Y, Wang Y, Zhou H, Yang GH, Fan J, Zhou J. Pemigatinib in previously treated Chinese patients with locally advanced or metastatic cholangiocarcinoma carrying FGFR2 fusions or rearrangements: A phase II study. Cancer Med. 2023 Feb;12(4):4137-4146. doi: 10.1002/cam4.5273. Epub 2022 Sep 20.

  PMID: 36127767 DERIVED

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

pemigatinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2020
• First Posted: February 5, 2020
• Study Start: March 3, 2020
• Primary Completion: January 29, 2021
• Study Completion: August 31, 2023
• Last Updated: May 30, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)