Temsirolimus as Second-line Therapy in HCC
Recruitment status was: Recruiting
|Unresectable or Metastatic Hepatocellular Carcinoma||Drug: Temsirolimus||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Temsirolimus as Second-line Therapy in Patients With Advanced, Unresectable Hepatocellular Carcinoma|
- Disease ProgressionThe primary outcome measure is to determine the proportion of patients who are progression free at 3 months.
- Response rateResponse rate, clinical benefit rate (complete + partial response + stable disease > 12 weeks) and overall survival with temsirolimus
- Safety and tolerabilityNumber and frequency of adverse events and serious adverse events will be monitored.
- Biochemical responseBiochemical response (>50% decline in AFP levels from baseline) with temsirolimus
- PharmacokineticsPharmacokinetics will be assessed: AUC pre-dose, 1, 3, 24,48, 72 and 162 hours post dose.
- Circulating tumor cells levelsFeasibility and utility of circulating tumor cells in this patient population
|Study Start Date:||February 2010|
|Estimated Study Completion Date:||March 2013|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Currently, no standard therapy exists for patients who progress on sorafenib. mTOR signaling is often up-regulated in HCC promoting cell growth and survival. This process is inhibited by rapamycin, a specific inhibitor of mTOR. Temsirolimus, a rapamycin analog, may delay tumor progression by inhibiting mTOR in HCC.Intervention: Temsirolimus IV
Eligible patients will receive temsirolimus IV on days 1,8,15 every 21 days. Treatment will continue till disease progression or untolerable side effects
Please refer to this study by its ClinicalTrials.gov identifier: NCT01567930
|Contact: Steve West, BS, CCRPfirstname.lastname@example.org|
|United States, Tennessee|
|Boston Baskin Cancer Foundation||Recruiting|
|Memphis, Tennessee, United States, 38120|
|Principal Investigator:||Jasgit Sachdev, MD||University of Tennessee Cancer Institute|