check_circleStudy Completed
Neoplasms
Bayer Identifier:
14747
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
BAY86-9766 plus gemcitabine Phase I study in Asian
Trial purpose
This is an open-label, uncontrolled, Phase Ib study designed to evaluate the safety, tolerability, and pharmacokinetics of BAY86-9766 when given as a single agent and in combination with gemcitabine in Asian patients with advanced or refractory solid tumors.Blood samples for PK (pharmacokinetics) analyses will be collected after a single dose of BAY86-9766, multiple doses of BAY86-9766, and combination treatment of gemcitabine and BAY86-9766.
Safety evaluation will include adverse events assessment, vital signs, laboratory tests, 12-lead ECG ECG (electrocardiography), cardiac function test, and ophthalmologic examination at various time points during the study.
Safety evaluation will include adverse events assessment, vital signs, laboratory tests, 12-lead ECG ECG (electrocardiography), cardiac function test, and ophthalmologic examination at various time points during the study.
Key Participants Requirements
Sex
BothAge
18 YearsTrial summary
Enrollment Goal
23Trial Dates
February 2013 - February 2015Phase
Phase 1Could I Receive a placebo
NoProducts
Refametinib (BAY86-9766)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Kashiwa, 277-8577, Japan | |
Completed | shanghai, 200032, China | |
Completed | Seoul, 03080, Korea, Republic Of |
Primary Outcome
- Plasma concentration of BAY86-9766date_rangeTime Frame:Multiple time points up to 6 dayenhanced_encryptionNoSafety Issue:
- Plasma concentration of M17 and M11date_rangeTime Frame:Multiple time points up to 6 dayenhanced_encryptionNoSafety Issue:
- Plasma concentration of Gemcitabinedate_rangeTime Frame:Multiple time points up to 6 dayenhanced_encryptionNoSafety Issue:
- Plasma concentration of dFdUdate_rangeTime Frame:Multiple time points up to 6 dayenhanced_encryptionNoSafety Issue:
- Number of adverse events, or abnormal parameters as a measure of safety and tolerabilityParameters are laboratory parameters, vital signs, ECG parameters, cardiac function, and parameters of ophthalmologic examinationsdate_rangeTime Frame:Up to 1 yearenhanced_encryptionYesSafety Issue:
Secondary Outcome
- Efficacy of BAY86-9766 shown by a discrete scaleElements of the scale are :Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD)date_rangeTime Frame:Up to 1 yearenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
OtherAllocation
N/ABlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1