Everolimus and Pasireotide (SOM230) in Patients With Advanced or Metastatic Hepatocellular Carcinoma
|Advanced Adult Hepatocellular Carcinoma||Drug: Everolimus Drug: Pasireotide||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Single Arm Study of Everolimus and Pasireotide (SOM230) in Patients With Advanced or Metastatic Hepatocellular Carcinoma (HCC)|
- Time to Progression (TTP) [ Time Frame: 3.5 years ]Time to progression is defined as the time from study enrollment until radiological progression in a previously embolized lobe, development of new lesions in an untreated lobe, or evidence of extrahepatic progression (based on modified Hepatocellular Carcinoma (HCC) Response Evaluation Criteria In Solid Tumors (RECIST) criteria). Patients will be followed until death. Patients that die of causes unrelated to the study drug without evidence of progression will be censored.
- Number of Individuals Experiencing Toxicity [ Time Frame: 3.5 years ]Safety determinations are based on the rate of drug-related adverse events (AEs) reported based upon the toxicity as measured by the NCI Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0).
- Overall Survival (OS) [ Time Frame: 3.5 years ]Overall survival is defined as the time from study enrollment until death.
- Objective Response Rate (ORR) [ Time Frame: 3.5 years ]
ORR is the rate of complete responses (CRs) + partial responses (PRs) as determined by RECIST (v1.1) and modified HCC RECIST criteria. Responses defined as follows:
CR: disappearance of all clinical/radiological evidence of tumor including any intratumoral arterial enhancement in all target lesions.
Partial Response (PR): at least a 30% decrease in the sum of diameters of viable (contrast enhancement in the arterial phase) target lesions, referencing the baseline sum.
Stable Disease (SD): any cases that do not qualify for either partial response or progressive disease.
Progressive Disease (PD): an increase of at least 20% in the sum of the diameters of viable target lesions, referencing the nadir sum, and/or the appearance of one or more new lesions. A new hepatic nodule signals PD when the longest diameter is at least 10 mm and the nodule shows the typical vascular pattern of HCC on dynamic imaging or if at least 1-cm interval growth is seen in subsequent scans.
|Study Start Date:||December 2011|
|Study Completion Date:||March 2015|
|Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
Experimental: Everolimus + pasireotide
Oral Everolimus 7.5 mg administered daily for 28 days per cycle, plus pasireotide Long Acting Release (LAR) 60 mg administered by intramuscular injection once per 28 day cycle on day 1.
Everolimus 7.5 mg administered daily for 28 days per cycle until disease progression or unacceptable toxicity.
Other Names:Drug: Pasireotide
Monthly (every 28 days) intramuscular injection of long-acting pasireotide (pasireotide LAR 60 mg) repeated on day 1 of every 28 day cycle until disease progression or unacceptable toxicity.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01488487
|United States, Florida|
|Moffitt Cancer Center|
|Tampa, Florida, United States, 33612|
|United States, North Carolina|
|University of North Carolina at Chapel Hill Lineberger Comprehensive Cancer Center|
|Chapel Hill, North Carolina, United States, 27599|
|Comprehensive Cancer Center of Wake Forest University|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||Hanna Sanoff, MD||University of North Carolina at Chapel Hill Lineberger Comprehensive Cancer Center|