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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-26

Study Completion Date

2021-03-08

Brief Summary

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

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Detailed Description

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Conditions

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Solid Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patients with advanced malignancies with FGF/FGFR alterations

Group Type EXPERIMENTAL

Pemigatinib

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No