check_circleStudy Completed
Neoplasms
Bayer Identifier:
15734
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Open label study of BAY1082439 in patients with advanced cancer
Trial purpose
The purpose of this study is to determine the safety, tolerability and the pharmacokinetics of BAY1082439
Key Participants Requirements
Sex
BothAge
21 - N/ATrial summary
Enrollment Goal
60Trial Dates
November 2012 - February 2017Phase
Phase 1Could I Receive a placebo
NoProducts
BAY1082439 Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Singapore, 119228, Singapore | |
Completed | Singapore, 169610, Singapore | |
Completed | Seoul, 120-752, Korea, Republic Of | |
Completed | Taipei, 10002, Taiwan | |
Completed | Seoul, 03080, Korea, Republic Of | |
Withdrawn | Houston, 77030, United States | |
Withdrawn | St. Louis, 63110, United States | |
Withdrawn | Ann Arbor, 48109, United States | |
Withdrawn | Dallas, 75201, United States | |
Withdrawn | Tainan, 70428, Taiwan |
Primary Outcome
- Number of participants with adverse events as a measure of safety and tolerabilitydate_rangeTime Frame:Up to 2 yearsenhanced_encryptionYesSafety Issue:
- Maximum tolerated dose of BAY1082439date_rangeTime Frame:Up to 1 yearenhanced_encryptionYesSafety Issue:
- Maximum observed plasma concentration (Cmax) of BAY1082439 after a single dosedate_rangeTime Frame:Serial PK samples will be selected during cycle 1 day 1 (pre-dose and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose) and sparse samples during the rest of the cycle as well as in cycle 2enhanced_encryptionNoSafety Issue:
- Time to Cmax (tmax) of BAY1082439 after a single dosedate_rangeTime Frame:Serial PK samples will be selected during cycle 1 day 1 (pre-dose and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose) and sparse samples during the rest of the cycle as well as in cycle 2enhanced_encryptionNoSafety Issue:
- Area under the plasma concentration-time curve (AUC[0-t]) of BAY1082439 after a single dosedate_rangeTime Frame:Serial PK samples will be selected during cycle 1 day 1 (pre-dose and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose) and sparse samples during the rest of the cycle as well as in cycle 2enhanced_encryptionNoSafety Issue:
Secondary Outcome
- Area under the concentration-time curve over the dosing interval (AUC[0-tau])date_rangeTime Frame:PK parameters following single and repeat-dose administration in cycle 1enhanced_encryptionNoSafety Issue:
- Maximum observed concentration (Cmax)date_rangeTime Frame:PK parameters following single and repeat-dose administration in cycle 1enhanced_encryptionNoSafety Issue:
- Time of occurrence of Cmax (tmax)date_rangeTime Frame:PK parameters following single and repeat-dose administration in cycle 1enhanced_encryptionNoSafety Issue:
- Terminal phase half-life (t1/2)date_rangeTime Frame:PK parameters following single and repeat-dose administration in cycle 1enhanced_encryptionNoSafety Issue:
- Tumor response based on Response Evaluation Criteria in Solid Tumors, Version 1.1date_rangeTime Frame:Up to 2 years
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
N/ABlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1