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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00688753
Recruitment Status : Completed
First Posted : June 3, 2008
Results First Posted : November 26, 2015
Last Update Posted : September 2, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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

Condition or disease Intervention/treatment Phase
Carcinoma Renal Cell Non Clear Cell Renal Carcinoma Papillary Cell Renal Carcinoma Adenocarcinoma Drug: RAD001 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Arm, Multicenter Phase II Trial of RAD001 as Monotherapy in the Treatment of Advanced Papillary Renal Cell Cancer
Study Start Date : July 2009
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: RAD001
two 5 mg tablets of everolimus orally, once daily
 Drug: RAD001


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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.

  4. 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.

  5. Incidence of Adverse Events, Serious Adverse Events, and Death. [ Time Frame: End of trial ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00688753


Locations
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Belgium
Novartis Investigative Site
Brussels, Belgium, BE-B-1200
Novartis Investigative Site
Gent, Belgium, 9000
France
Novartis Investigative Site
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
Germany
Novartis Investigative Site
Berlin, Germany, 10098
Novartis Investigative Site
Hannover, Germany, 30625
Novartis Investigative Site
Muenster, Germany, 48149
Italy
Novartis Investigative Site
Arezzo, AR, Italy, 52100
Novartis Investigative Site
Cremona, CR, Italy, 26100
Novartis Investigative Site
Pavia, PV, Italy, 27100
Novartis Investigative Site
Napoli, Italy, 80132
Poland
Novartis Investigative Site
Otwock, Poland, 05-400
Spain
Novartis Investigative Site
Barcelona, Catalunya, Spain, 08003
Novartis Investigative Site
Barcelona, Cataluña, Spain, 08907
Novartis Investigative Site
Valencia, Comunidad Valenciana, Spain, 46009
Novartis Investigative Site
Barcelona, Spain, 08041
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00688753    
Other Study ID Numbers: CRAD001LFR08
2008-006181-28
First Posted: June 3, 2008    Key Record Dates
Results First Posted: November 26, 2015
Last Update Posted: September 2, 2016
Last Verified: July 2016
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
renal cell carcinoma
non clear cell carcinoma
papillary cell renal carcinoma
adults
everolimus
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
 Kidney Diseases
Urologic Diseases
Male Urogenital Diseases
Everolimus
MTOR Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents