Safety and Pharmacokinetics of Regorafenib and Cetuximab in Combination
NCT01973868 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42
Last updated 2019-04-09
Summary
To establish safety, tolerability and pharmacokinetics of regorafenib and cetuximab in combination, and to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D)
Conditions
- Neoplasms
Interventions
- DRUG
-
Regorafenib (Stivarga, BAY73-4506)
- DRUG
-
Cetuximab (ERBITUX)
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Bayer Study Director · Bayer
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-11-21
- Primary Completion
- 2017-01-31
- Completion
- 2018-04-03
- FDA Drug
- Yes
Countries
- United States
Study Locations
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