check_circleStudy Completed
Advanced Cancer
Bayer Identifier:
15507
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
RDEA119 and Sorafenib Combination Dose Escalation Study
Trial purpose
Phase 1/2 dose escalation study to investigate the combination of RDEA119 and sorafenib in advanced cancer patients.
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
62Trial Dates
November 2008 - April 2012Phase
Phase 1/Phase 2Could I Receive a placebo
NoProducts
Refametinib (BAY86-9766)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Roswell Park Cancer Institute | Buffalo, 14263, United States |
Completed | USC/Norris Comprehensive Cancer Center and LAC/USC Medical Center | Los Angeles, 90033, United States |
Completed | Texas Oncology-Tyler | Tyler, 75702, United States |
Completed | Texas Oncology - Baylor Charles A. Simmons Cancer Center | Dallas, 75246, United States |
Completed | New York Oncology Hematology, PC | Albany, 12206, United States |
Completed | Greenville Hospital System University Medical Center, (ITOR) | Greenville, 29605, United States |
Completed | Toronto General Hospital | Toronto, M5G 2N2, Canada |
Terminated | UPenn | Philadelphia, 19104, United States |
Completed | Comprehensive Cancer Centers of Nevada | Las Vegas, 89169, United States |
Completed | James P. Wilmot Cancer Center | Rochester, 14642, United States |
Primary Outcome
- To evaluate the safety and tolerability of escalating continuous oral dosing of RDEA119 in combination with sorafenib in advanced cancer patients.date_rangeTime Frame:28 Daysenhanced_encryptionYesSafety Issue:
Secondary Outcome
- Determine PK and PD of drugs in combination, describe responses, correlate toxicity and response profiles to select biomarkers, and evaluate the safety and tolerability of the MTD of this combination in select tumors in Phase 2 portion.date_rangeTime Frame:28 daysenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
N/ABlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1