check_circleStudy Completed
Neoplasms
Bayer Identifier:
16519
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Open label Phase I dose escalation study with BAY1143572 in patients with advanced cancer
Trial purpose
The purpose of this study Part A is to determine the safety, tolerability and the pharmacokinetics of BAY1143572 in subjects with advanced malignancies, which are either refractory to or ineligible for treatment with standard agents.
The purpose of this study Part B is:
Determine the safety, tolerability, pharmacokinetics (PK) and maximum tolerated dose (MTDG-CSF) of BAY1143572 with concurrent administration of the granulocyte colony-stimulating factors (G-CSF) in an intermittent and continuous dosing schedule in subjects with advanced malignancies.
The purpose of this study Part B is:
Determine the safety, tolerability, pharmacokinetics (PK) and maximum tolerated dose (MTDG-CSF) of BAY1143572 with concurrent administration of the granulocyte colony-stimulating factors (G-CSF) in an intermittent and continuous dosing schedule in subjects with advanced malignancies.
Key Participants Requirements
Sex
BothAge
21 - N/ATrial summary
Enrollment Goal
80Trial Dates
September 2013 - September 2016Phase
Phase 1Could I Receive a placebo
NoProducts
Atuveciclib (BAY1143572)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Seoul, 110-744, Korea, Republic Of | |
Completed | Singapore, 119228, Singapore | |
Completed | Singapore, 169610, Singapore | |
Completed | Seoul, 120-752, Korea, Republic Of | |
Completed | New York, 10032, United States | |
Terminated | Boston, 02215, United States | |
Terminated | Taipei, 10002, Taiwan | |
Completed | Seoul, 05505, Korea, Republic Of | |
Completed | Hackensack, 07601, United States | |
Terminated | Charleston, 29425, United States | |
Completed | Ann Arbor, 48109, United States | |
Completed | Fayetteville, 72703, United States | |
Terminated | Boston, 02215, United States |
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 (MTD) of BAY1143572In Part A: Maximum tolerated dose (MTD) of BAY1143572 In Part B; Maximum tolerated dose ( MTD) with G-CSF of BAY114357 The MTD is defined as the highest dose that can be given such that not more than 20% of subjects experience a dose limiting toxicity (DLT) during cycle 1.date_rangeTime Frame:Up to 1 yearenhanced_encryptionYesSafety Issue:
Secondary Outcome
- Maximum total drug concentration (Cmax)date_rangeTime Frame:Cycle 1, Day 1 and Day 15 (each cycle is 28 days)enhanced_encryptionNoSafety Issue:
- Area under the plasma concentration-time curve from time zero to 24 hours (AUC(0-24)date_rangeTime Frame:Cycle 1, Day 1 and Day 15 (each cycle is 28 days)
- Area under the plasma concentration-time curve from time zero to infinity (AUC)date_rangeTime Frame:Cycle 1, Day 1 and Day 15 (each cycle is 28 days)
- Time of maximum observed concentration (tmax)date_rangeTime Frame:Cycle 1, Day 1 and Day 15 (each cycle is 28 days)
- Tumor response based on RECIST 1.1 or Cheson 2007 criteriadate_rangeTime Frame:Up to 100 weeks
- Biomarker evaluation by determination of MYC protein expression and PCNA mRNAPCNA: proliferating cell nuclear Antigen mRNA: messenger ribonucleic aciddate_rangeTime Frame:Cycle 1, Day 1, Day 8 and Day 15 (each cycle is 28 days)
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
Non-randomizedBlinding
Open LabelAssignment
Parallel AssignmentTrial Arms
2