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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00688753
First received: May 30, 2008
Last updated: May 8, 2014
Last verified: May 2014
  Purpose

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
Carcinoma
Renal Cell
Non Clear Cell Renal Carcinoma
Papillary Cell Renal Carcinoma
Adenocarcinoma
Drug: RAD001
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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: Every 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disease control rate (SD + PR + CR) [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]
  • Objective response rate [ Time Frame: At statistical analysis ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: At statistical analysis ] [ Designated as safety issue: No ]
  • Median progression free survival [ Time Frame: At statistical analysis ] [ Designated as safety issue: No ]
  • Incidence of adverse events, serious adverse events, changes from baseline in vital signs, and laboratory results [ Time Frame: Every 14 days in the first 3 months, then every 28 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: July 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RAD001 Drug: RAD001

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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

Contacts
Contact: Novartis Pharmaceuticals +41613241111
Contact: Novartis Pharmaceuticals

Locations
Belgium
Novartis Investigative Site Recruiting
Brussels, Belgium, BE-B-1200
Novartis Investigative Site Recruiting
Gent, Belgium, 9000
France
Novartis Investigative Site Terminated
Bordeaux Cedex, France, 33075
Novartis Investigative Site Withdrawn
Caen Cedex, France, 14021
Novartis Investigative Site Active, not recruiting
Lyon Cedex, France, 69373
Novartis Investigative Site Terminated
Marseille, France, 13273
Novartis Investigative Site Terminated
Paris, France, 75015
Novartis Investigative Site Active, not recruiting
Villejuif Cedex, France, 94805
Germany
Novartis Investigative Site Active, not recruiting
Berlin, Germany, 10098
Novartis Investigative Site Active, not recruiting
Hannover, Germany, 30625
Novartis Investigative Site Active, not recruiting
Muenster, Germany, 48149
Novartis Investigative Site Withdrawn
München, Germany, 81675
Italy
Novartis Investigative Site Completed
Arezzo, AR, Italy, 52100
Novartis Investigative Site Terminated
Cremona, CR, Italy, 26100
Novartis Investigative Site Terminated
Pavia, PV, Italy, 27100
Novartis Investigative Site Terminated
Napoli, Italy, 80132
Poland
Novartis Investigative Site Recruiting
Otwock, Poland, 05-400
Novartis Investigative Site Withdrawn
Warszawa, Poland, 02-781
Novartis Investigative Site Withdrawn
Wroclaw, Poland, 50-556
Spain
Novartis Investigative Site Completed
Barcelona, Catalunya, Spain, 08003
Novartis Investigative Site Active, not recruiting
Barcelona, Cataluña, Spain, 08907
Novartis Investigative Site Completed
Valencia, Comunidad Valenciana, Spain, 46009
Novartis Investigative Site Completed
Barcelona, Spain, 08025
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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
Last Updated: May 8, 2014
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
adults
everolimus

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

ClinicalTrials.gov processed this record on October 01, 2014