RDEA119 and Sorafenib Combination Dose Escalation Study
A Phase 1/2 Study of the Combination of RDEA119 and Sorafenib in Patients With Advanced Cancer
2 other identifiers
interventional
62
2 countries
10
Brief Summary
Phase 1/2 dose escalation study to investigate the combination of RDEA119 and sorafenib in advanced cancer patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2008
Typical duration for phase_1
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 4, 2008
CompletedFirst Posted
Study publicly available on registry
November 5, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedOctober 17, 2016
October 1, 2016
3.4 years
November 4, 2008
October 14, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
To evaluate the safety and tolerability of escalating continuous oral dosing of RDEA119 in combination with sorafenib in advanced cancer patients.
28 Days
Secondary Outcomes (1)
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.
28 days
Study Arms (1)
RDEA119 with Sorafenib
EXPERIMENTALTotal daily doses of RDEA119 from 10 mg/day to 100 mg/day and sorafenib from 400 mg/day to 800 mg/day.
Interventions
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (10)
USC/Norris Comprehensive Cancer Center and LAC/USC Medical Center
Los Angeles, California, 90033, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169, United States
New York Oncology Hematology, PC
Albany, New York, 12206, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
James P. Wilmot Cancer Center
Rochester, New York, 14642, United States
UPenn
Philadelphia, Pennsylvania, 19104, United States
Greenville Hospital System University Medical Center, (ITOR)
Greenville, South Carolina, 29605, United States
Texas Oncology - Baylor Charles A. Simmons Cancer Center
Dallas, Texas, 75246, United States
Texas Oncology-Tyler
Tyler, Texas, 75702, United States
Toronto General Hospital
Toronto, Ontario, M5G 2N2, Canada
Related Publications (1)
Adjei AA, Richards DA, El-Khoueiry A, Braiteh F, Becerra CH, Stephenson JJ Jr, Hezel AF, Sherman M, Garbo L, Leffingwell DP, Iverson C, Miner JN, Shen Z, Yeh LT, Gunawan S, Wilson DM, Manhard KJ, Rajagopalan P, Krissel H, Clendeninn NJ. A Phase I Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Combination Therapy with Refametinib plus Sorafenib in Patients with Advanced Cancer. Clin Cancer Res. 2016 May 15;22(10):2368-76. doi: 10.1158/1078-0432.CCR-15-1681. Epub 2015 Dec 7.
PMID: 26644411RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 4, 2008
First Posted
November 5, 2008
Study Start
November 1, 2008
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
October 17, 2016
Record last verified: 2016-10