check_circleStudy Completed
Neoplasm
Bayer Identifier:
11651
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Continuous dosing of BAY73-4506 in patients with advanced malignancies
Trial purpose
Continuous dosing of BAY73-4506 in patients with advanced cancer
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
86Trial Dates
February 2007 - November 2013Phase
Phase 1Could I Receive a placebo
NoProducts
Stivarga (Regorafenib, BAY73-4506)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Institute for Drug Development | San Antonio, 78229, United States |
Completed | South Texas Accelerated Research Therapeutics, LLC | San Antonio, 78229-3307, United States |
Completed | University of California, Los Angeles | Los Angeles, 90095, United States |
Completed | University of Texas MD Anderson Cancer Center | Houston, 77030, United States |
Completed | University of Colorado Hospital | Aurora, 80045, United States |
Primary Outcome
- Maximum Tolerated Dose (MTD)date_rangeTime Frame:Within first 4 weeks of treatmentenhanced_encryptionYesSafety Issue:
- Maximum observed plasma concentration after single dose administration (Cmax)date_rangeTime Frame:Blood samples were collected on Cycle 1, Day 1. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10, 24, and 48 h post-doseenhanced_encryptionNoSafety Issue:
- Area under the concentration vs. time curve from zero to infinity after single (first) dose (AUC)date_rangeTime Frame:Blood samples were collected on Cycle 1, Day 1. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10, 24, and 48 h post-doseenhanced_encryptionNoSafety Issue:
- Cmax at steady state during a dosing interval (Cmax,ss)date_rangeTime Frame:Blood samples were collected at on Cycle 2, Day 1 and on Cycle 3, Day 1 for expansion cohort. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10 and 24h post-dose.enhanced_encryptionNoSafety Issue:
- AUC from time 0 to 24 hours at steady state(AUC(0-24),ss)date_rangeTime Frame:Blood samples were collected on Cycle 2, Day 1 and on Cycle 3, Day 1 for expansion cohort. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10 and 24h post-dose.enhanced_encryptionNoSafety Issue:
Secondary Outcome
- AUC from time 0 to the last data point > lower limit of quantification (LLOQ) (AUC(0-tlast))date_rangeTime Frame:Blood samples were collected on Cycle 1, Day 1. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10, 24, and 48 h post-doseenhanced_encryptionNoSafety Issue:
- Area under the concentration vs. time curve from zero to infinity after single (first) dose divided by dose (AUC/D)date_rangeTime Frame:Blood samples were collected on Cycle 1, Day 1. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10, 24, and 48 h post-doseenhanced_encryptionNoSafety Issue:
- Maximum observed plasma concentration after single dose administration divided by dose (Cmax/D)date_rangeTime Frame:Blood samples were collected on Cycle 1, Day 1. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10, 24, and 48 h post-doseenhanced_encryptionNoSafety Issue:
- Time to Reach Maximum Observed Plasma Concentration (Tmax)date_rangeTime Frame:Blood samples were collected on Cycle 1, Day 1. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10, 24, and 48 h post-dose.enhanced_encryptionNoSafety Issue:
- Half-life associated with the terminal slope (T1/2)date_rangeTime Frame:Blood samples were collected on Cycle 1, Day 1. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10, 24, and 48 h post-dose.enhanced_encryptionNoSafety Issue:
- Cmax at steady state during a dosing interval divided by dose (Cmax,ss/D)date_rangeTime Frame:Blood samples were collected at on Cycle 2, Day 1 and on Cycle 3, Day 1 for expansion cohort. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10 and 24h post-doseenhanced_encryptionNoSafety Issue:
- AUC from time 0 to 24 hours at steady state divided by dose (AUC(0-24)ss/D)date_rangeTime Frame:Blood samples were collected on Cycle 2, Day 1 and on Cycle 3, Day 1 for expansion cohort. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10 and 24h post-doseenhanced_encryptionNoSafety Issue:
- Time to Reach Maximum Observed Plasma Concentration at steady state (Tmax,ss)date_rangeTime Frame:Blood samples were collected on Cycle 2, Day 1 and on Cycle 3, Day 1 for expansion cohort. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10 and 24h post-doseenhanced_encryptionNoSafety Issue:
- Ratio of Cmax,ss/Cmax (RACmax)date_rangeTime Frame:Blood samples were collected on Cycle 1, Day 1 and Cycle 2, Day 1 and on Cycle 3, Day 1 for expansion cohort. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10 and 24h post-doseenhanced_encryptionNoSafety Issue:
- Ratio of Cmin,ss/Cmin (RACmin)date_rangeTime Frame:Blood samples were collected on Cycle 1, Day 1 and Cycle 2, Day 1 and on Cycle 3, Day 1 for expansion cohort. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10 and 24h post-doseenhanced_encryptionNoSafety Issue:
- Ratio of AUCt,ss/AUCt (RAAUC)AUCt,ss is AUC during any dose interval at steady statedate_rangeTime Frame:Blood samples were collected on Cycle 1, Day 1 and Cycle 2, Day 1 and on Cycle 3, Day 1 for expansion cohort. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10 and 24h post-doseenhanced_encryptionNoSafety Issue:
- Ratio of AUCt,ss/AUC (RLIN)date_rangeTime Frame:Blood samples were collected on Cycle 1, Day 1 and Cycle 2, Day 1. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10 and 24h post-doseenhanced_encryptionNoSafety Issue:
- Biomarker vascular endothelial growth factor (VEGF) plasma levelsdate_rangeTime Frame:No data obtainedenhanced_encryptionNoSafety Issue:
- Biomarker soluble vascular endothelial growth factor receptor 2 (sCEGFR-2) plasma levelsdate_rangeTime Frame:No data obtainedenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
OtherAllocation
Non-randomizedBlinding
Open LabelAssignment
Parallel AssignmentTrial Arms
8