check_circleStudy Completed
Oncology
Bayer Identifier:
15823
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
The second objective include the evaluation of safety, tolerability, and efficacy of Chinese patents treated with Regorafenib
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
18Trial Dates
April 2015 - June 2016Phase
Phase 1Could I Receive a placebo
NoProducts
Stivarga (Regorafenib, BAY73-4506)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
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 hoursenhanced_encryptionNoSafety Issue:
- 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 hoursenhanced_encryptionNoSafety Issue:
- 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 hoursenhanced_encryptionNoSafety Issue:
- 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 hoursenhanced_encryptionNoSafety Issue:
- 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 hoursenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Number of participants with adverse events as a measure of safety and tolerabilitydate_rangeTime Frame:Up to 30 daysenhanced_encryptionYesSafety Issue:
- Tumor Response base don RECIST 1.1 criteriadate_rangeTime Frame:Up to 30 daysenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
N/ABlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1