RAPTOR: RAD001 as Monotherapy in the Treatment of Advanced Papillary Renal Cell Tumors Program in Europe (MACS0460)

July 26, 2016 updated by: Novartis Pharmaceuticals

A Single Arm, Multicenter Phase II Trial of RAD001 as Monotherapy in the Treatment of Advanced Papillary Renal Cell Cancer

To evaluate the preliminary efficacy and safety of RAD001 as monotherapy for first-line treatment of patients with metastatic papillary carcinoma of the kidney.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

92

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

  • Belgium
      • Brussels, Belgium, BE-B-1200
        • Novartis Investigative Site
      • Gent, Belgium, 9000
        • Novartis Investigative Site
  • France
      • Bordeaux Cedex, France, 33075
        • Novartis Investigative Site
      • Lyon Cedex, France, 69373
        • Novartis Investigative Site
      • Marseille, France, 13273
        • Novartis Investigative Site
      • Paris, France, 75015
        • Novartis Investigative Site
      • Villejuif Cedex, France, 94805
        • Novartis Investigative Site
  • Germany
      • Berlin, Germany, 10098
        • Novartis Investigative Site
      • Hannover, Germany, 30625
        • Novartis Investigative Site
      • Muenster, Germany, 48149
        • Novartis Investigative Site
  • Italy
      • Napoli, Italy, 80132
        • Novartis Investigative Site
    • AR
      • Arezzo, AR, Italy, 52100
        • Novartis Investigative Site
    • CR
      • Cremona, CR, Italy, 26100
        • Novartis Investigative Site
    • PV
      • Pavia, PV, Italy, 27100
        • Novartis Investigative Site
  • Poland
      • Otwock, Poland, 05-400
        • Novartis Investigative Site
  • Spain
      • Barcelona, Spain, 08041
        • Novartis Investigative Site
    • Catalunya
      • Barcelona, Catalunya, Spain, 08003
        • Novartis Investigative Site
    • Cataluña
      • Barcelona, Cataluña, Spain, 08907
        • Novartis Investigative Site
    • Comunidad Valenciana
      • Valencia, Comunidad Valenciana, Spain, 46009
        • Novartis Investigative Site

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  1. ≥ 18 years old.
  2. Patients with metastatic papillary renal cell carcinoma, type I or II.
  3. Patients with at least one measurable lesion.
  4. Patients with an ECOG Performance Status ≤1.
  5. Adequate bone marrow function.
  6. Adequate liver function.
  7. Adequate renal function.
  8. Adequate lipid profile.

Exclusion criteria:

  1. Patients who had radiation therapy within 28 days prior to start of study.
  2. Patients who have received prior systemic treatment for their metastatic RCC.
  3. Patients who received prior therapy with VEGF pathway inhibitor.
  4. Patients who have previously received systemic mTOR inhibitors.
  5. Patients with a known hypersensitivity everolimus or other rapamycins or to its excipients.
  6. Patients with uncontrolled central nervous system (CNS) metastases.
  7. Patients receiving chronic systemic treatment with corticosteroids or another immunosuppressive agent.
  8. Patients with a known history of HIV seropositivity.
  9. Patients with autoimmune hepatitis.
  10. Patients with an active, bleeding diathesis.
  11. Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study.
  12. Patients who have a history of another primary malignancy and off treatment ≤ 3 years, with the exception of non-melanoma skin cancer and carcinoma in situ of the uterine cervix.
  13. Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods.
  14. Patients who are using other investigational agents or who had received investigational drugs ≤ 4 weeks prior to study treatment start.
  15. Patients unwilling to or unable to comply with the protocol.

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: RAD001
two 5 mg tablets of everolimus orally, once daily
Drug: RAD001

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To Evaluate Efficacy of RAD001 as Monotherapy for the Treatment of Papillary Renal Cancer. Efficacy is Defined as the Percentage of Patients Progression-free at 6 Months.
Time Frame: 6 mos
PFSR at 6 months based on central review
6 mos

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease Control Rate (SD + PR + CR)
Time Frame: 6 mos
DCR was defined as the proportion of patients with a best overall response of CR, PR or SD and ORR as the percentage of patients with CR or PR
6 mos
Objective Response Rate
Time Frame: End of trial
ORR is defined as the proportion of patients with tumor size reduction of a predefined amount and for a minimum time period. Response duration usually is measured from the time of initial response until documented tumor progression
End of trial
Duration of Response
Time Frame: End of trial
The DOR analysis applied only to patients whose overall response was CR or PR and was defined as the time from onset of response (CR/PR) to progression or death from any cause.
End of trial
Median Progression Free Survival
Time Frame: End of trial
PFS was defined as the time from first study drug administration to objective tumor progression or death from any cause.
End of trial
Incidence of Adverse Events, Serious Adverse Events, and Death.
Time Frame: End of trial
End of trial

Collaborators and Investigators

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

Sponsor

Novartis Pharmaceuticals

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

July 1, 2009

Primary Completion (ACTUAL)

October 1, 2014

Study Completion (ACTUAL)

October 1, 2014

Study Registration Dates

First Submitted

May 30, 2008

First Submitted That Met QC Criteria

May 30, 2008

First Posted (ESTIMATE)

June 3, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

September 2, 2016

Last Update Submitted That Met QC Criteria

July 26, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRAD001LFR08
  • 2008-006181-28

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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