CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 29 enrolled
Drug / intervention
Temsirolimus +1 moredrug
Likely dose
Temsirolimus 10 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/NCT01687673
NCT01687673Phase 2Completed
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Phase II Trial of the Combination of Temsirolimus and Sorafenib in Advanced Hepatocellular Carcinoma

University of California, San Francisco·interventional·Posted Sep 19, 2012·Updated Dec 7, 2020

In Brief

A Phase 2 clinical trial evaluating Temsirolimus and Sorafenib: for Hepatocellular Carcinoma. Completed, enrolled 29 participants across 2 sites.

Detailed Summary

This Phase II trial is being developed following the completion of a Phase I study of the combination of temsirolimus and sorafenib in 25 first-line therapy patients with advanced hepatocellular carcinoma (December 2009 through April 2012). The maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of the combination of temsirolimus is 10 mg IV weekly plus sorafenib 200 mg (oral, twice daily).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatocellular Carcinoma
CountriesUnited States
CollaboratorsRobert H. Lurie Cancer Center, Pfizer

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 19, 2012
Enrollment StartOct 5, 2012
Primary CompletionApr 26, 2016
Study CompletionJan 9, 2020
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 13.8 years ago

Interventions

Temsirolimusdrug

10 mg weekly will be administered intravenously over 30 to 60 minutes using an infusion pump starting on Cycle 1, Day 1 of study enrollment.

Sorafenib:drug

200 mg tablet twice daily starting on Cycle 1, Day 1 of study enrollment after completion of temsirolimus infusion.