CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 70 enrolled
Drug / intervention
Paclitaxel +2 moredrug
Likely dose
Paclitaxel 175mg/m2from 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/NCT01014351
NCT01014351Phase 2Completed
CompareCT.gov

A Phase II Study of Everolimus in Combination With Paclitaxel and Carboplatin in Patients With Metastatic Melanoma

SCRI Development Innovations, LLC·interventional·Posted Nov 17, 2009·Updated Mar 26, 2014

In Brief

A Phase 2 clinical trial evaluating Paclitaxel, Carboplatin, and 1 other intervention for Metastatic Melanoma. Completed, enrolled 70 participants across 12 sites.

Detailed Summary

Based on data demonstrating synergy between paclitaxel and mammalian target of rapamycin (mTOR) inhibition, the investigators propose that the addition of everolimus to paclitaxel with carboplatin should lead to improvements in efficacy as measured by progression-free survival and response rate.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Melanoma
CountriesUnited States
CollaboratorsNovartis

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 17, 2009
Enrollment StartFeb 1, 2010
Primary CompletionFeb 1, 2012
Study CompletionAug 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 16.6 years ago

Interventions

Paclitaxeldrug

Paclitaxel, 175mg/m2 by IV infusion over 1-3 hours on day 1 of every 21 day cycle

Carboplatindrug

Carboplatin, AUC 6 given by IV infusion over 20-30 minutes on day 1 of every 21 day cycle

Everolimusdrug

Everolimus, 5 mg by mouth (PO) once a day, continuous dosing every 21-day cycle