check_circleStudy Completed
Neoplasms
Bayer Identifier:
15205
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Japanese BAY80-6946 monotherapy Phase I study
Trial purpose
This study will be conducted as an open label, single centre, Phase I study of PI3K (phosphatidyl inositol 3 kinase) inhibitor BAY80-6946 in Japanese patients with advanced or refractory solid tumours. The eligible subjects will be dosed intravenously at Day 1, Day 8 and Day 15 with three weeks on and one week off in each treatment cycle.
Key Participants Requirements
Sex
BothAge
20 - 80 YearsTrial summary
Enrollment Goal
10Trial Dates
August 2011 - July 2012Phase
Phase 1Could I Receive a placebo
NoProducts
Aliqopa (Copanlisib, BAY80-6946)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Kashiwa, 277-8577, Japan |
Primary Outcome
- Number of subjects with adverse eventsdate_rangeTime Frame:169 daysenhanced_encryptionYesSafety Issue:
- Maximum drug concentration in plasma after single dose administration (Cmax)date_rangeTime Frame:0 - 168 hours in Cycle1 Day1, 0 - 25 hours in Cycle1 Day15, 0 - 8 hours in Cycle3 Day15
- Cmax divided by dose (mg) per kg body weight (Cmax,norm)date_rangeTime Frame:0 - 168 hours in Cycle1 Day1, 0 - 25 hours in Cycle1 Day15, 0 - 8 hours in Cycle3 Day15
- Cmax divided by dose (mg) (Cmax/D)date_rangeTime Frame:0 - 168 hours in Cycle1 Day1, 0 - 25 hours in Cycle1 Day15, 0 - 8 hours in Cycle3 Day15
- Area under the concentration-time curve time 0 to 8 hours (AUC(0-8))date_rangeTime Frame:0 - 168 hours in Cycle1 Day1, 0 - 25 hours in Cycle1 Day15, 0 - 8 hours in Cycle3 Day15
- Area under the concentration-time curve from time 0 to 25 hours (AUC(0-25))date_rangeTime Frame:0 - 168 hours in Cycle1 Day1, 0 - 25 hours in Cycle1 Day15
- AUC(0-25) divided by dose (mg) per kg body weight (AUC(0-25)norm)date_rangeTime Frame:0 - 168 hours in Cycle1 Day1, 0 - 25 hours in Cycle1 Day15
- AUC(0-25) divided by dose (mg) (AUC(0-25)/D)date_rangeTime Frame:0 - 168 hours in Cycle1 Day1, 0 - 25 hours in Cycle1 Day15
- AUC from time 0 to last data point (AUC(0-tlast))date_rangeTime Frame:0 - 168 hours in Cycle1 Day1, 0 - 25 hours in Cycle1 Day15
- Time to maximum drug concentration in plasma (tmax)date_rangeTime Frame:0 - 168 hours in Cycle1 Day1, 0 - 25 hours in Cycle1 Day15, 0 - 8 hours in Cycle3 Day 15
Secondary Outcome
- Area under the plasma concentration-time curve of (AUC) of BAY80-6946date_rangeTime Frame:0 - 168 hours in Cycle1 Day1enhanced_encryptionNoSafety Issue:
- Half-life associated with terminal slope of drug in plasma (t1/2)date_rangeTime Frame:0 - 168 hours in Cycle1 Day1
- Mean residence time of drug in plasma (MRT)date_rangeTime Frame:0 - 168 hours in Cycle1 Day1
- Total body clearance of drug from plasma (CL)date_rangeTime Frame:0 - 168 hours in Cycle1 Day1
- Volume of drug distribution during terminal phase after single dose administration (Vz)date_rangeTime Frame:0 - 168 hours in Cycle1 Day1
- Volume of drug distribution during steady state after single dose administration (Vss)date_rangeTime Frame:0 - 168 hours in Cycle1 Day1
- Accumulation ratio calculated from AUC(0-8) after multiple dosing and AUC(0-8) after single dosing (RAAUC(0-8))date_rangeTime Frame:0 - 8 hours in Cycle3 Day15
- Accumulation ratio calculated from AUC(0-25) after multiple dosing and AUC(0-25) after single dosing (RAAUC(0-25))date_rangeTime Frame:0 - 25 hours in Cycle1 Day15
- Accumulation ration calculated from Cmax after multiple dosing and Cmax after single dosing (RACmax)date_rangeTime Frame:0 - 168 hours in Cycle1 Day1, 0 - 25 hours in Cycle1 Day15
- Overall tumor response rateProportion of subjects with confirmed complete and partial responsedate_rangeTime Frame:176 days
- Overall disease control rateProportion of subjects who had a best response rating of complete response, partial response or stable diseasedate_rangeTime Frame:176 days
- Time to progression of cancer growthdate_rangeTime Frame:176 days
- Progression-free survival timedate_rangeTime Frame:176 days
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
Non-randomizedBlinding
Open LabelAssignment
Factorial AssignmentTrial Arms
2