MedTrace Logo

A Study to Identify a Biomarker Predictive for Response on Everolimus in Solid Tumors (CPCT-03)

NCT01566279 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2018-03-09

No results posted yet for this study

Summary

The investigators hypothesize that certain mutations in the individual cancer genomes will predict response to Everolimus therapy. To identify possible genetic mutations that affect tumor response to Everolimus the investigators will obtain sequence analysis of tumors from all patients that will be treated with Everolimus in this study. Moreover, the investigators performed a systematic review of the currently available data to identify mutations that could be predictive for increased mTOR activity in cancer cells. These mutations have been described to lead to mTOR activation but their predictive value for response to Everolimus therapy remains unclear. The investigators will use the data generated in the investigators own prospective treatment study and the data from literature to select patients for entry into a second part of this trial. In this part the investigators want to test the hypothesis that selecting patients based on their specific genetic mutations increases the likelihood of response.

Conditions

  • Unspecified Adult Solid Tumor, Protocol Specific

Interventions

DRUG

Everolimus

All patients will receive everolimus 10mg q.d.

Sponsors & Collaborators

  • UMC Utrecht

    lead OTHER

Principal Investigators

  • M.H.G. Langenberg, MD/PhD · UMC Utrecht

  • N. Steeghs, MD/PhD · NKI-AvL

  • M.J.A. de Jonge, MD/PhD · Erasmus Medical Center

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2015-11-30
Completion
2016-11-30

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs

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 NCT01566279 on ClinicalTrials.gov