check_circleStudy Completed
Neoplasms
Bayer Identifier:
14856
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Clinical study to evaluate safety and maximum tolerated dose of BAY1000394 given in a 4 week on / 2 week off schedule in subjects with advanced malignancies
Trial purpose
Clinical study to determine safety, tolerability, and maximum tolerated dose of BAY1000394 given in 4 week on / 2 week off schedule to patients with advanced solid tumors
Key Participants Requirements
Sex
FemaleAge
18 - N/ATrial summary
Enrollment Goal
10Trial Dates
December 2010 - September 2011Phase
Phase 1Could I Receive a placebo
NoProducts
Roniciclib (BAY1000394)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Scottsdale, 85258, United States | |
Completed | St. Louis, 63110, United States | |
Completed | Chapel Hill, 27599, United States |
Primary Outcome
- Number of subjects with Adverse Events as a measure safetydate_rangeTime Frame:Up to 3 years or longer if indicatedenhanced_encryptionYesSafety Issue:
- Maximum tolerated dose: Measured by adverse event profiledate_rangeTime Frame:Up to 3 years or longer if indicatedenhanced_encryptionYesSafety Issue:
Secondary Outcome
- Biomarkers evaluation measured by Enzyme-linked immunosorbent assay (ELISA)date_rangeTime Frame:Up to 3 years or longer if indicatedenhanced_encryptionYesSafety Issue:
- Tumor Response evaluation measured by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)date_rangeTime Frame:Up to 3 years or longer if indicatedenhanced_encryptionYesSafety Issue:
- Peak Plasma Concentration (Cmax) of BAY1000394date_rangeTime Frame:Approximately 18 monthsenhanced_encryptionNoSafety Issue:
- Pharmacokinetics parameters will be measured using Peak Plasma Time (tmax) of BAY1000394date_rangeTime Frame:Approximately 18 monthsenhanced_encryptionNoSafety Issue:
- Area under the plasma concentration versus time curve from 0 to tn (AUC(0 tn)) of BAY1000394date_rangeTime Frame:Approximately 18 monthsenhanced_encryptionNoSafety Issue:
- Area under the plasma concentration versus time curve (AUC) of BAY1000394date_rangeTime Frame:Approximately 18 monthsenhanced_encryptionNoSafety Issue:
- Half-life of BAY1000394date_rangeTime Frame:Approximately 18 monthsenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
Non-randomizedBlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1