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

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: Adenocarcinoma; Carcinoma; Renal Cell; Non Clear Cell Renal Carcinoma; Papillary Cell Renal Carcinoma
• Intervention / Treatment: Drug: RAD001

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Phase 2

Contacts and Locations

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

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

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

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.	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)	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	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	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	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.		End of trial

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

General Publications

• Escudier B, Molinie V, Bracarda S, Maroto P, Szczylik C, Nathan P, Negrier S, Weiss C, Porta C, Grunwald V, Albiges L. Open-label phase 2 trial of first-line everolimus monotherapy in patients with papillary metastatic renal cell carcinoma: RAPTOR final analysis. Eur J Cancer. 2016 Dec;69:226-235. doi: 10.1016/j.ejca.2016.08.004. Epub 2016 Sep 24.

Study record dates

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: everolimus; renal cell carcinoma; adults; non clear cell carcinoma; papillary cell renal carcinoma
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Carcinoma, Renal Cell; Carcinoma; Physiological Effects of Drugs; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Everolimus
• Other Study ID Numbers: CRAD001LFR08; 2008-006181-28