check_circleStudy Completed

Oncology

Regorafenib Phase I study in mainland Chinese patients

Trial purpose

The primary objective of this study is to define the pharmacokinetic of Regorafenib administered orally as a single agent in Chinese patients with advance solid tumors.
The second objective include the evaluation of safety, tolerability, and efficacy of Chinese patents treated with Regorafenib

Key Participants Requirements

Sex

Both

Age

18 - N/A

Trial summary

Enrollment Goal
18
Trial Dates
April 2015 - June 2016
Phase
Phase 1
Could I Receive a placebo
No
Products
Stivarga (Regorafenib, BAY73-4506)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
shanghai, 200032, China

Primary Outcome

  • Cmax (maximum drug concentration in plasma)
    date_rangeTime Frame:
    Cycle 0 day 1, 0、0.5、1、2、3、4、6、8、12、24、36、48、72、96 hours
    enhanced_encryption
    Safety Issue:
    No
  • AUC(0-24) (AUC from time 0 h to time 24 h post-administration)
    date_rangeTime Frame:
    Cycle 0 day1, 0、0.5、1、2、3、4、6、8、12、24 hours
    enhanced_encryption
    Safety Issue:
    No
  • AUC(0-tlast) (AUC from time zero to the last data point>LLOQ)
    date_rangeTime Frame:
    Cycle0 day 1, 0、0.5、1、2、3、4、6、8、12、24、36、48、72、96 hours
    enhanced_encryption
    Safety Issue:
    No
  • Cmax.ss (Cmax at steady-state during a dosage interval)
    date_rangeTime Frame:
    Cycle 1 day 21, 0,0.5,1,2,3,4,6,8,12,24,36,48,72,96 hours
    enhanced_encryption
    Safety Issue:
    No
  • AUCt.ss (AUC for the dosing interval at steady-state)
    date_rangeTime Frame:
    cycle 1 day 21 0,0.5,1,2,3,4,6,8,12,24 hours
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Number of participants with adverse events as a measure of safety and tolerability
    date_rangeTime Frame:
    Up to 30 days
    enhanced_encryption
    Safety Issue:
    Yes
  • Tumor Response base don RECIST 1.1 criteria
    date_rangeTime Frame:
    Up to 30 days
    enhanced_encryption
    Safety Issue:
    No

Trial design

Uncontrolled, open-label, non-randomized, phase I study to investigate the pharmacokinetics, safety, tolerability, and efficacy of Regorafenib in Chinese patients (China mainland) with advanced, refractory solid tumors)
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1