Temsirolimus + Sorafenib in Advanced Hepatocellular Carcinoma (HCC)
NCT01335074 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL
Last updated 2016-11-15
Summary
Sorafenib is the standard therapy for advanced liver cancer but often shows dose-limiting toxicities with the need to reduce the applied dose of the compound. As this limits the overall response rate of the therapy, a combination with temsirolimus, an inhibitor of mTOR signaling, will be investigated regarding safety and tolerability in patients with advanced liver cancer under a reduced dose of sorafenib.
Conditions
Interventions
- DRUG
-
Temsirolimus + Sorafenib
200mg bid Sorafenib + 15, 20 or 25 mg Temsirolimus
Sponsors & Collaborators
-
Philipps University Marburg
lead OTHER
Principal Investigators
-
Patrick Michl, MD · Dept. of Gastroenterology
-
Matthias Ocker, MD · Inst. for Surgical Research
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-04-30
- Primary Completion
- 2013-12-31
Countries
- Germany
Study Locations
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