check_circleStudy Completed
Hematologic neoplasms
Bayer Identifier:
18117
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Phase I trial of BAY1251152 for advanced blood cancers
Trial purpose
The purpose of this study is to identify the most appropriate dose that can be safely administered and that can have an effect on blood cancer cells. Once that safe dose is identified, additional patients will be asked to join the study to further evaluate the safety and effectiveness of the study drug. The study will also investigate the pharmacokinetics (study of what the body does to the drug), as well as pharmacodynamics (study of what the drug does to the body), which may provide information about the effects of BAY 1251152. The study will also measure some biological markers (markers of biological activity in your body) that can be used to predict the response and safety of the proposed treatment.
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
21Trial Dates
June 2016 - August 2018Phase
Phase 1Could I Receive a placebo
NoProducts
BAY1251152Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Nashville, 37232, United States | |
Completed | New York, 10032, United States | |
Completed | Madrid, 28040, Spain | |
Withdrawn | Houston, 77030, United States | |
Completed | Bronx, 10461, United States | |
Completed | Dresden, 01307, Germany | |
Completed | Cardiff, CF14 4XN, United Kingdom |
Primary Outcome
- Maximum tolerated dose(MTD)To determine the MTD of BAY1251152 in subjects with advanced hematological neoplasmsdate_rangeTime Frame:21 daysenhanced_encryptionYesSafety Issue:
- Recommended Phase 2 dose (RP2D)To determine the RP2D of BAY1251152 based on safety, tolerability, pharmacokinetic, and pharmacodynamic data in subjects with advanced hematological neoplasmsdate_rangeTime Frame:Up to 30 monthsenhanced_encryptionYesSafety Issue:
- Number of adverse events (AE)For assessment of the safety (ECG, vital signs, clinical significant abnormal laboratory results… etc.)and tolerability of BAY 1251152 in subjects with advanced hematological neoplasmsdate_rangeTime Frame:Up to 30 monthsenhanced_encryptionYesSafety Issue:
- Pharmacokinetics (PK) is determined by maximum concentration (Cmax)date_rangeTime Frame:21 daysenhanced_encryptionNoSafety Issue:
- Pharmacokinetics (PK) is determined by Area Under concentration versus time Curve (AUC)date_rangeTime Frame:21 daysenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Response assessment of BAY 1251152 in hematological malignancies based on the internationally accepted criteria for the specific hematological malignancy which patient is suffering fromTo assess the clinical efficacy of BAY 1251152 in subjects with advanced hematological neoplasmsdate_rangeTime Frame:Up to 30 monthsenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
Non-randomizedBlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
2Additional Information
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