Phase 1 Study of Pemigatinib in Patients With Advanced Malignancies With FGF/FGFR Alterations

NCT04258527 | Completed Phase 1

• 1 other identifier: CIBI375A101
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase 1 study to investigate the characteristics of PK, PD and safety in subjects with advanced malignancies with FGF/FGFR alterations.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (3)

• Maximum observed plasma concentration (Cmax) during the dosing interval and Cmin of Pemigatinib as monotherapy

  Day 1 to Day 16

• Time to maximum plasma concentration (Tmax) of Pemigatinib as monotherapy

  Day 1 to Day 16

• Area under the single-dose plasma concentration-time curve (AUC0-t) of Pemigatinib as monotherapy

  Day 1 to Day 16

Secondary Outcomes (1)

• Safety of pemigatinib as monotherapy as assessed by the frequency, duration, and severity of adverse events

  From screening through 30-35 days after end of treatment, up to 6 months

Study Arms (1)

Patients with advanced malignancies with FGF/FGFR alterations

EXPERIMENTAL

Drug: Pemigatinib

Interventions

Pemigatinib DRUG

Pemigatinib will be self-administered as at 13.5mg a QD oral treatment on a 2-week-on therapy and 1-week-off therapy schedule.

Patients with advanced malignancies with FGF/FGFR alterations

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 malignancy which was considered to be surgically unresectable advanced, relapse or metastatic .
• Radiographically measurable disease per RECIST v 1.1
• Documentation of FGF/FGFR alteration..
• Documented disease progression after standard therapy ,or no standard therapy available.
• 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)

Cancer Hospital of Tianjin Medical University

Tianjin, China

Location

Related Publications (1)

• Deng T, Zhang L, Shi Y, Bai G, Pan Y, Shen A, Han X, Yang Z, Chen M, Zhou H, Luo Y, Zheng S, Ba Y. Pharmacokinetics, pharmacodynamics and efficacy of pemigatinib (a selective inhibitor of fibroblast growth factor receptor 1-3) monotherapy in Chinese patients with advanced solid tumors: a phase i clinical trial. Invest New Drugs. 2023 Dec;41(6):808-815. doi: 10.1007/s10637-023-01396-x. Epub 2023 Oct 27.

  PMID: 37889382 DERIVED

MeSH Terms

Interventions

pemigatinib

Study Design

• Study Type: interventional
• Phase: phase 1
• 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 6, 2020
• Study Start: March 26, 2020
• Primary Completion: July 2, 2020
• Study Completion: March 8, 2021
• Last Updated: July 23, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)