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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
Sponsor:
Information provided by (Responsible Party):
Innovent Biologics (Suzhou) Co. Ltd.

Study Description
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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
Cholangiocarcinoma Drug: Pemigatinib Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Pemigatinib

Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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China, Shanghai
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai, China
Sponsors and Collaborators
Innovent Biologics (Suzhou) Co. Ltd.
More Information
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Responsible Party: Innovent Biologics (Suzhou) Co. Ltd.
ClinicalTrials.gov Identifier: NCT04256980    
Other Study ID Numbers: CIBI375A201
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Innovent Biologics (Suzhou) Co. Ltd.:
CCA
FGFR2
Pemigatinib
Additional relevant MeSH terms:
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Cholangiocarcinoma
Adenocarcinoma
Carcinoma
 Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms