check_circleStudy Completed

Neoplasms

Rogaratinib (BAY1163877) in Chinese patients

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

18 - N/A

Trial summary

Enrollment Goal
1
Trial Dates
January 2019 - April 2020
Phase
Phase 1
Could I Receive a placebo
No
Products
Rogaratinib (BAY1163877)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Beijing HospitalBeijing, 100730, China
Withdrawn
Jiangsu Province HospitalNanjing, 210029, China
Withdrawn
Tongji University Affiliated Shanghai Pulmonary Hospitalshanghai, 200433, China

Primary Outcome

  • Frequency of Treatment-Emergent Adverse Events(TEAEs)
    date_rangeTime Frame:
    30 days after last dose of rogaratinib
  • Severity of Treatment-Emergent Adverse Events(TEAEs)
    date_rangeTime Frame:
    30 days after last dose of rogaratinib
  • Cmax: Maximum drug concentration in plasma after dose administration
    Single dose
    date_rangeTime Frame:
    Cycle 1 Day 1 (each cycle is 21 days)
  • AUC(0-12): AUC from time zero to 12 hours p.a. after first-dose administration
    Single dose
    date_rangeTime Frame:
    Cycle 1 Day 1 (each cycle is 21 days)
  • Cmax,md: Cmax after multiple dosing
    Multiple dose
    date_rangeTime Frame:
    Cycle 1 Day 15 (each cycle is 21 days)
  • AUC(0-12)md: AUC(0-12) after multiple dosing
    Multiple dose
    date_rangeTime Frame:
    Cycle 1 Day 15 (each cycle is 21 days)

Secondary Outcome

  • Phosphate levels
    date_rangeTime Frame:
    Within 7-14 days after the last dose of rogaratinib
  • Response rate
    Response rate is defined as the proportion of patients who have a best overall response rating of complete response (CR) and partial response (PR) that is achieved during treatment.
    date_rangeTime Frame:
    Within 7-14 days after the last dose of rogaratinib

Trial design

An open label, Phase 1 study to evaluate the safety, tolerability and pharmacokinetics of rogaratinib (BAY1163877) in Chinese patients with FGFR-positive refractory, locally advanced, or metastatic solid tumors
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
N/A
Assignment
Single Group Assignment
Trial Arms
1