Temsirolimus as Second-line Therapy in HCC
|ClinicalTrials.gov Identifier: NCT01567930|
Recruitment Status : Unknown
Verified March 2012 by University of Tennessee Cancer Institute.
Recruitment status was: Recruiting
First Posted : March 30, 2012
Last Update Posted : December 17, 2012
|Condition or disease||Intervention/treatment||Phase|
|Unresectable or Metastatic Hepatocellular Carcinoma||Drug: Temsirolimus||Phase 2|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Temsirolimus as Second-line Therapy in Patients With Advanced, Unresectable Hepatocellular Carcinoma|
|Study Start Date :||February 2010|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||March 2013|
- Drug: Temsirolimus
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 effectsOther Name: Torisel
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|