check_circleStudy Completed
Medical Oncology
Bayer Identifier:
17350
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Phase I study of oral BAY 1217389 in combination with intravenous paclitaxel
Trial purpose
Determine the safety, tolerability, maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of oral BAY1217389 given in combination with intravenous (IV) paclitaxel using an intermittent dosing schedule (2 days on / 5 days off) in subjects with advanced malignancies.
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
75Trial Dates
February 2015 - April 2019Phase
Phase 1Could I Receive a placebo
NoProducts
BAY1217389Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | San Antonio, 78229-3307, United States | |
Completed | Santa Monica, 90403, United States | |
Completed | Denver, 80262, United States | |
Completed | Hackensack, 07601-1991, United States | |
Completed | Houston, 77030, United States | |
Completed | ROTTERDAM, 3075 EA, Netherlands | |
Completed | New Haven, 06520, United States |
Primary Outcome
- Maximum tolerated dose (MTD)The MTD is defined as the highest dose that can be given such that the dose-limiting toxicity (DLT) rate of the combination treatment is not more than 10% higher than the cumulative DLT rate of the standard single-agent treatment across all previous and the current cohort.date_rangeTime Frame:Up to 28 days (Cycle 1)enhanced_encryptionYesSafety Issue:
- Number of subjects with adverse events and serious adverse events as a measure of safety and tolerability.date_rangeTime Frame:After the first study drug administration and up to 30 days after the end of treatment with study drug before primary completion analysis of the study, up to 3 yearsenhanced_encryptionYesSafety Issue:
- Maximum observed drug concentration (Cmax) of BAY1217389 in plasmadate_rangeTime Frame:From pre-dose up to 96 hours post-dose on C1D-8 and C1D-4; from pre-dose up to 12 hours post-dose on C1D8 and C1D9enhanced_encryptionYesSafety Issue:
- Area under the concentration versus time curve from zero to 12 hours (AUC [0-12]) of BAY1217389 in plasmadate_rangeTime Frame:From pre-dose up to 12 hours post-dose on C1D-4, C1D8 and C1D9enhanced_encryptionYesSafety Issue:
- Area under the concentration versus time curve from zero to 96 hours (AUC [0-96]) of BAY1217389 in plasmadate_rangeTime Frame:From pre-dose up to 96 hours post-dose on C1D-4
- Maximum observed drug concentration (Cmax) of paclitaxel in plasmadate_rangeTime Frame:From pre-dose up to 24 hours post-dose on C1D1 and C1D8
- Area under the concentration versus time curve from zero to infinity (AUC) of paclitaxel in plasmadate_rangeTime Frame:From pre-dose up to 24 hours post-dose on C1D1 and C1D8
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Open LabelAssignment
Parallel AssignmentTrial Arms
2