CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 24 enrolled
Drug / intervention
Everolimus +1 moredrug
Likely dose
Everolimus 7.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01488487
NCT01488487Phase 2Completed
CompareCT.gov

Phase II Single Arm Study of Everolimus and Pasireotide (SOM230) in Patients With Advanced or Metastatic Hepatocellular Carcinoma (HCC)

UNC Lineberger Comprehensive Cancer Center·interventional·Posted Dec 8, 2011·Updated Apr 7, 2016

In Brief

A Phase 2 clinical trial evaluating Everolimus and Pasireotide for Advanced Adult Hepatocellular Carcinoma. Completed, enrolled 24 participants across 3 sites.

Detailed Summary

The purpose of this study is to estimate the time to disease progression when everolimus and pasireotide are given together in patients with advanced or metastatic HCC who have not had any prior systemic therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Adult Hepatocellular Carcinoma
CountriesUnited States
CollaboratorsNovartis Pharmaceuticals

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 8, 2011
Enrollment StartDec 1, 2011
Primary CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 14.6 years ago

Interventions

Everolimusdrug

Everolimus 7.5 mg administered daily for 28 days per cycle until disease progression or unacceptable toxicity.

Pasireotidedrug

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.