check_circleStudy Completed
Neoplasms
Bayer Identifier:
15091
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Japanese BAY86-9766 monotherapy Phase I study
Trial purpose
This is an uncontrolled, open-label, non-randomized phase I / pharmacokinetic study of oral BAY86-9766 to investigate the safety, tolerability, pharmacokinetics, and efficacy profiles in Japanese patients with advanced solid tumors
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
12Trial Dates
November 2010 - April 2012Phase
Phase 1Could I Receive a placebo
NoProducts
Refametinib (BAY86-9766)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Kashiwa, 277-8577, Japan |
Primary Outcome
- Safety evaluation due to results of physical examinations, vital signs, AEs, abnormal laboratory tests and 12-lead ECG, cardiac function test and ophthalmological examination.date_rangeTime Frame:At the end of 30-day follow up after discontinuation of study drug administrationenhanced_encryptionYesSafety Issue:
- Calculation of pharmacokinetic parameters of BAY86-9766 and its metabolite (M17).date_rangeTime Frame:Cycle 1 Day 22 and Day 23 for Cohorts 1 & 2 and Cohorts 3 & 4, respectively.enhanced_encryptionNoSafety Issue:
Secondary Outcome
- Response ratedate_rangeTime Frame:On average 3 monthsenhanced_encryptionNoSafety Issue:
- Disease control ratedate_rangeTime Frame:On average 3 monthsenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
Non-randomizedBlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
4