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

Solid Tumor Clinical Trial

Official title:

A Phase 1, Open-Label, Pharmacokinetic(PK), Pharmacodynamics(PD) and Safety Study of Pemigatinib in Patients With Advanced Malignancies With FGF/FGFR Alterations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04258527
• Other study ID #: CIBI375A101
• Status: Completed
• Phase: Phase 1
• Start date: March 26, 2020
• Est. completion date: March 8, 2021

Study information

• Verified date: July 2021
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 8, 2021
• Est. primary completion date: July 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Men and women, aged 18 or older.

2. Histologically or cytologically confirmed malignancy which was considered to be surgically unresectable advanced, relapse or metastatic .

3. Radiographically measurable disease per RECIST v 1.1

4. Documentation of FGF/FGFR alteration..

5. Documented disease progression after standard therapy ,or no standard therapy available.

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

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

Drug:
• Pemigatinib
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.

Locations

Country	Name	City	State
China	Cancer Hospital of Tianjin Medical University	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plasma concentration (Cmax) during the dosing interval and Cmin of Pemigatinib as monotherapy		Day 1 to Day 16
Primary	Time to maximum plasma concentration (Tmax) of Pemigatinib as monotherapy		Day 1 to Day 16
Primary	Area under the single-dose plasma concentration-time curve (AUC0-t) of Pemigatinib as monotherapy		Day 1 to Day 16
Secondary	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