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

This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
First received: May 30, 2008
Last updated: October 21, 2015
Last verified: October 2015
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 Intervention Phase
Renal Cell
Non Clear Cell Renal Carcinoma
Papillary Cell Renal Carcinoma
Drug: RAD001
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    PFSR at 6 months based on central review

Secondary Outcome Measures:
  • Disease Control Rate (SD + PR + CR) [ Time Frame: 6 mos ] [ Designated as safety issue: No ]
    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

  • Objective Response Rate [ Time Frame: End of trial ] [ Designated as safety issue: No ]
    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

  • Duration of Response [ Time Frame: End of trial ] [ Designated as safety issue: No ]
    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.

  • Median Progression Free Survival [ Time Frame: End of trial ] [ Designated as safety issue: No ]
    PFS was defined as the time from first study drug administration to objective tumor progression or death from any cause.

  • Incidence of Adverse Events, Serious Adverse Events, and Death. [ Time Frame: End of trial ] [ Designated as safety issue: Yes ]

Enrollment: 85
Study Start Date: July 2009
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RAD001
two 5 mg tablets of everolimus orally, once daily
Drug: RAD001


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00688753

Novartis Investigative Site
Brussels, Belgium, BE-B-1200
Novartis Investigative Site
Gent, Belgium, 9000
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
Novartis Investigative Site
Berlin, Germany, 10098
Novartis Investigative Site
Hannover, Germany, 30625
Novartis Investigative Site
Muenster, Germany, 48149
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
Novartis Investigative Site
Otwock, Poland, 05-400
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
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00688753     History of Changes
Other Study ID Numbers: CRAD001LFR08, 2008-006181-28
Study First Received: May 30, 2008
Results First Received: October 21, 2015
Last Updated: October 21, 2015
Health Authority: United States: Food and Drug Administration
Belgium:Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten / Agence Fédérale des Médicaments et des Produits de Santé
France:Agence Francaise des Sécurité Sanitaire des Produits de Santé
Germany:Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)
Italy:Agenzia Italiana del Farmaco (AIFA)
Poland:Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych
Spain:Agencia Española del Medicamento
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:
renal cell carcinoma
non clear cell carcinoma
papillary cell renal carcinoma

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Kidney Diseases
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2015