MedTrace Logo

Study of Everolimus With Paclitaxel and Carboplatin in Patients With Metastatic Melanoma

NCT01014351 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2014-03-26

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

Paclitaxel

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

DRUG

Carboplatin

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

DRUG

Everolimus

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

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • SCRI Development Innovations, LLC

    lead OTHER

Principal Investigators

  • John D. Hainsworth, M.D. · SCRI Development Innovations, LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2012-02-29
Completion
2013-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01014351 on ClinicalTrials.gov