check_circleStudy Completed

Advanced Cancer

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

Both

Age

18 - N/A

Trial summary

Enrollment Goal
62
Trial Dates
November 2008 - April 2012
Phase
Phase 1/Phase 2
Could I Receive a placebo
No
Products
Refametinib (BAY86-9766)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Roswell Park Cancer InstituteBuffalo, 14263, United States
Completed
USC/Norris Comprehensive Cancer Center and LAC/USC Medical CenterLos Angeles, 90033, United States
Completed
Texas Oncology-TylerTyler, 75702, United States
Completed
Texas Oncology - Baylor Charles A. Simmons Cancer CenterDallas, 75246, United States
Completed
New York Oncology Hematology, PCAlbany, 12206, United States
Completed
Greenville Hospital System University Medical Center, (ITOR)Greenville, 29605, United States
Completed
Toronto General HospitalToronto, M5G 2N2, Canada
Terminated
UPennPhiladelphia, 19104, United States
Completed
Comprehensive Cancer Centers of NevadaLas Vegas, 89169, United States
Completed
James P. Wilmot Cancer CenterRochester, 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 Days
    enhanced_encryption
    Safety Issue:
    Yes

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 days
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

A Phase 1/2 Study of the Combination of RDEA119 and Sorafenib in Patients With Advanced Cancer
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1