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

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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

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
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Objective response rate per RECIST 1.1

Secondary Outcome

 PFS(PFS= first dose to progressive disease or death)

Condition

Cholangiocarcinoma

Intervention

Pemigatinib

Study Arms / Comparison Groups

 Pemigatinib in patients with advanced/metastatic or surgically
Description:  Patients with advanced/metastatic or surgically unresectable cholangiocarcinoma

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

54

Start Date

March 3, 2020

Completion Date

September 2021

Primary Completion Date

April 2021

Eligibility 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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, 0512-69566088, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT04256980

Organization ID

CIBI375A201


Responsible Party

Sponsor

Study Sponsor

Innovent Biologics (Suzhou) Co. Ltd.


Study Sponsor

, , 


Verification Date

February 2020