check_circleStudy Completed
Advanced Cancer
Bayer Identifier:
15505
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Phase 1 Dose-escalation PK/PD Trial in Advanced Cancer Patients
Trial purpose
Primary Objective: To evaluate the safety of escalating oral doses of RDEA119, a MEK inhibitor, in advanced cancer patients.
Secondary Objectives:
• To describe the initial PK of different doses of RDEA119 when given once orally on Day 1 of the study
• To describe the PK of different doses of RDEA119 when given orally as continuous dosing.
• To examine the inhibition of MEK products (p-ERK), cytokine products, and other protein biomarkers
• To expand the MTD dose cohort to evaluate the safety, tolerability and PK/PD of the recommended Phase 2 dose
• To explore the presence of genotype, PD markers, cell growth and a marker of apoptosis, in paired tumor biopsy samples of patients' tumors pre-dose and during dosing in a minimum of 10 patients in the expanded cohort
Secondary Objectives:
• To describe the initial PK of different doses of RDEA119 when given once orally on Day 1 of the study
• To describe the PK of different doses of RDEA119 when given orally as continuous dosing.
• To examine the inhibition of MEK products (p-ERK), cytokine products, and other protein biomarkers
• To expand the MTD dose cohort to evaluate the safety, tolerability and PK/PD of the recommended Phase 2 dose
• To explore the presence of genotype, PD markers, cell growth and a marker of apoptosis, in paired tumor biopsy samples of patients' tumors pre-dose and during dosing in a minimum of 10 patients in the expanded cohort
Key Participants Requirements
Sex
BothAge
18 YearsTrial summary
Enrollment Goal
69Trial Dates
November 2007 - August 2012Phase
Phase 1Could I Receive a placebo
NoProducts
Refametinib (BAY86-9766)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | TGen Clinical Research Services at Scottsdale Healthcare | Scottsdale, 85258, United States |
Completed | UCHSC | Aurora, 80045, United States |
Completed | Roswell Park Cancer | Buffalo, 14263, United States |
Primary Outcome
- Safety will be assessed as adverse and drug related events, clinical laboratory test results (hematology, chemistry, coagulation, and urinalysis), vital signs, 12-lead electrocardiograms (ECGs), and physical examinationdate_rangeTime Frame:35 Daysenhanced_encryptionYesSafety Issue:
Secondary Outcome
- Pharmacokinetics and Pharmacodynamicsdate_rangeTime Frame:35 Daysenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
N/ABlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1