check_circleStudy Completed
Neoplasms
Bayer Identifier:
14996
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Phase I study of BAY73-4506 in Chinese patients with advanced, refractory solid tumors
Trial purpose
This will be an uncontrolled, open-label, non-randomized, phase I study.
The primary objectives of this study are to define the pharmacokinetics (PK) and to evaluate the safety and tolerability of Regorafenib administered orally as a single agent in Chinese patients with advanced solid tumors. The secondary objectives are to evaluate tumor response of patients treated with Regorafenib.
The primary objectives of this study are to define the pharmacokinetics (PK) and to evaluate the safety and tolerability of Regorafenib administered orally as a single agent in Chinese patients with advanced solid tumors. The secondary objectives are to evaluate tumor response of patients treated with Regorafenib.
Key Participants Requirements
Sex
BothAge
18 - 99 YearsTrial summary
Enrollment Goal
33Trial Dates
July 2010 - November 2012Phase
Phase 1Could I Receive a placebo
NoProducts
Stivarga (Regorafenib, BAY73-4506)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | National Cancer Center | Singapore, 169610, Singapore |
Completed | Queen Mary Hospital | Hong Kong, Hong Kong |
Completed | Prince of Wales Hospital | Shatin, Hong Kong |
Completed | National University Hospital | Singapore, 119228, Singapore |
Primary Outcome
- Pharmacokinetics as measured by cmax and AUCdate_rangeTime Frame:Cycle 0, Day 1-5,Cycle 1 Day 1,8,15,21,Cycle 2 Day 1,Modified Dosing Cycle Day 21enhanced_encryptionnoSafety Issue:
- Adverse Event collectiondate_rangeTime Frame:every 1-2 weeksenhanced_encryptionyesSafety Issue:
Secondary Outcome
- Objective tumor response ratedate_rangeTime Frame:Every 8 weeks for the first 6 cycles, afterwards every 12 weeksenhanced_encryptionnoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
Non-randomizedBlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1