NCT01335074

Temsirolimus + Sorafenib in Advanced Hepatocellular Carcinoma (HCC)

Temsirolimus for the Treatment of Advanced Hepatocellular Carcinoma in Patients With Intolerance to Sorafenib

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Philipps University Marburg · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Inhibitors of the PI3K/Akt and mTOR signaling pathway have recently been established as novel potent anti-cancer agents for solid and hematologic malignancies. Several pre-clinical reports have shown a good anti-tumor activity in different HCC models and first reports from clinical trials in HCC promise a good efficacy in inhibiting angiogenesis and tumor cell growth. mTOR inhibition has also been shown to enhance the activity of other cytotoxic agents. Sorafenib also interferes with tumor cell survival, proliferation and angiogenesis by inhibiting molecular pathways independent of the PI3K/Akt/mTOR signaling. We therefore expect an at least additive effect by inhibiting two parallel but independent intracellular pathways in HCC tumor cells that will prolong overall survival and time to progression.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Temsirolimus + Sorafenib	200mg bid Sorafenib + 15, 20 or 25 mg Temsirolimus

Timeline

• Start date: 2011-04-01
• Primary completion: 2013-12-01
• First posted: 2011-04-13
• Last updated: 2016-11-15

Locations

1 site across 1 country: Germany