RAD001 in Advanced Sarcoma

April 11, 2013 updated by: Jin-Hee Ahn, Asan Medical Center

A Phase II Multicenter Trial of RAD001 in Patients With Metastatic or Recurrent Sarcomas

This trial intends to test the efficacy and safety of RAD001 in patients with advanced sarcoma who failed to conventional chemotherapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This multicenter, phase II trial evaluated the efficacy and safety of everolimus in patients with metastatic or recurrent bone and soft tissue sarcoma after failure of anthracycline and/or ifosfamide.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Daegu, Korea, Republic of
        • Yeongnam University College of Medicine
      • Daejeon, Korea, Republic of, 301-721
        • Chungnam National University Hospital
      • Seoul, Korea, Republic of, 135-710
        • Samsung medical center
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 120-752
        • Yonsei Cancer Center
      • Seoul, Korea, Republic of, 126-1
        • Korea University
    • Gyeonggi
      • Seongnam, Gyeonggi, Korea, Republic of, 463-707
        • Seoul National University Bundang Hospital
    • N/A = Not Applicable
      • Seoul, N/A = Not Applicable, Korea, Republic of, 138-736
        • Asan Medical Center, University of Ulsan College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with histologically confirmed metastatic, unresectable bone or soft tissue sarcomas who had past treatment with anthracycline and/or ifosfamide to which the disease was primarily refractory or progressed after initial response.
  • Any of above drugs is allowed to be used as adjuvant treatment.
  • Unidimensionally measurable disease
  • 3 or less than prior chemotherapies
  • Age 17 years old or older
  • ECOG performance status 2 or less, Life expectancy 6 month or less
  • Adequate bone marrow, liver, kidney, and cardiac function
  • Written informed consent

Exclusion Criteria:

  • Pregnant or lactating patients
  • Patients with resectable metastasis
  • Patients with history of CNS metastasis
  • Gastrointestinal stromal tumors, chondrosarcoma, neuroblastoma
  • Hypersensitivity to the active substance, to other rapamycin derivatives, or to any of the excipients.
  • Any preexisting medical condition of sufficient severity to prevent full compliance with the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RAD001
RAD001 was given as 10 mg orally once daily, and one cycle was defined as 28 days.
Drug: RAD001
Other Names:
  • Everolimus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival rate at 16 weeks
Time Frame: 16 weeks
Determined as the proportion of progression-free (complete response, partial response and stable disease) at 16 weeks of treatment
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: Up to 24 months
Defined as the time from the initiation of everolimus to disease progression or death, whichever occurred first.
Up to 24 months
Overall survival
Time Frame: Up to 24 months
Defined from the initiation of everolimus to death of any cause.
Up to 24 months
Response rate
Time Frame: Up to 24 months
Defined as the proportion of complete response and partial response per RECIST criteria.
Up to 24 months
Toxicity
Time Frame: Up to 24 months
Any adverse events occurred during the treatment with study drug.
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Collaborators

Novartis

Investigators

  • Principal Investigator: Jin-Hee Ahn, MD, PhD, Asan Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

April 10, 2013

First Submitted That Met QC Criteria

April 11, 2013

First Posted (Estimate)

April 12, 2013

Study Record Updates

Last Update Posted (Estimate)

April 12, 2013

Last Update Submitted That Met QC Criteria

April 11, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRAD001CKR13T

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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