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Rogaratinib (BAY1163877) in Chinese Patients

NCT03788603 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2021-03-29

No results posted yet for this study

Summary

This study is planned to determine the safety and tolerability of rogaratinib in Chinese patients with fibroblast growth factor receptor (FGFR)-positive refractory, locally advanced, or metastatic solid tumors and to characterize the pharmacokinetics of rogaratinib in Chinese patients.

Conditions

  • Neoplasms

Interventions

DRUG

Rogaratinib (BAY1163877)

Rogaratinib will be administered on 20 days in Cycle 1 (single dosing on Day 1 and twice daily dosing on Days 3-21). In Cycles ≥2, rogaratinib will be administered twice daily for 21 days, with cycles repeated every 21 days. Treatment will be continued until death, tumor progression, unacceptable toxicity, consent withdrawal, or until another criterion is met for withdrawal from the study at the discretion of the investigator.

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-07
Primary Completion
2019-04-30
Completion
2020-04-14

Countries

  • China

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03788603 on ClinicalTrials.gov