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

• ClinicalTrials.gov Identifier: NCT04256980
• Recruitment Status: Active, not recruiting
• First Posted: February 5, 2020
• Last Update Posted: October 4, 2022
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
• Information provided by (Responsible Party): Innovent Biologics (Suzhou) Co. Ltd.

Tracking Information

• First Submitted Date: January 20, 2020
• First Posted Date: February 5, 2020
• Last Update Posted Date: October 4, 2022
• Actual Study Start Date: March 3, 2020
• Actual Primary Completion Date: June 27, 2022 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 4, 2020): 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 ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 4, 2020)

• 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Cholangiocarcinoma

Intervention

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

Study Arms

Experimental: Pemigatinib in patients with advanced/metastatic or surgically

Patients with advanced/metastatic or surgically unresectable cholangiocarcinoma

Intervention: Drug: Pemigatinib

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: October 3, 2022): 34
• Original Estimated Enrollment (submitted: February 4, 2020): 54
• Estimated Study Completion Date: December 30, 2023
• Actual Primary Completion Date: June 27, 2022 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT04256980
• Other Study ID Numbers: CIBI375A201
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Innovent Biologics (Suzhou) Co. Ltd.
• Original Responsible Party: Same as current
• Current Study Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Innovent Biologics (Suzhou) Co. Ltd.
• Verification Date: October 2022