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

Primary Purpose

Carcinoma, Renal Cell, Non Clear Cell Renal Carcinoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
RAD001
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma focused on measuring renal cell carcinoma, non clear cell carcinoma, papillary cell renal carcinoma, adults, everolimus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RAD001

Arm Description

two 5 mg tablets of everolimus orally, once daily

Outcomes

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.
PFSR at 6 months based on central review

Secondary Outcome Measures

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
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
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.
Median Progression Free Survival
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.

Full Information

First Posted
May 30, 2008
Last Updated
July 26, 2016
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00688753
Brief Title
RAPTOR: RAD001 as Monotherapy in the Treatment of Advanced Papillary Renal Cell Tumors Program in Europe
Acronym
MACS0460
Official Title
A Single Arm, Multicenter Phase II Trial of RAD001 as Monotherapy in the Treatment of Advanced Papillary Renal Cell Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Renal Cell, Non Clear Cell Renal Carcinoma, Papillary Cell Renal Carcinoma, Adenocarcinoma
Keywords
renal cell carcinoma, non clear cell carcinoma, papillary cell renal carcinoma, adults, everolimus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RAD001
Arm Type
Experimental
Arm Description
two 5 mg tablets of everolimus orally, once daily
Intervention Type
Drug
Intervention Name(s)
RAD001
Primary Outcome Measure Information:
Title
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.
Description
PFSR at 6 months based on central review
Time Frame
6 mos
Secondary Outcome Measure Information:
Title
Disease Control Rate (SD + PR + CR)
Description
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
Time Frame
6 mos
Title
Objective Response Rate
Description
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
Time Frame
End of trial
Title
Duration of Response
Description
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.
Time Frame
End of trial
Title
Median Progression Free Survival
Description
PFS was defined as the time from first study drug administration to objective tumor progression or death from any cause.
Time Frame
End of trial
Title
Incidence of Adverse Events, Serious Adverse Events, and Death.
Time Frame
End of trial

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: ≥ 18 years old. Patients with metastatic papillary renal cell carcinoma, type I or II. Patients with at least one measurable lesion. Patients with an ECOG Performance Status ≤1. Adequate bone marrow function. Adequate liver function. Adequate renal function. Adequate lipid profile. Exclusion criteria: Patients who had radiation therapy within 28 days prior to start of study. Patients who have received prior systemic treatment for their metastatic RCC. Patients who received prior therapy with VEGF pathway inhibitor. Patients who have previously received systemic mTOR inhibitors. Patients with a known hypersensitivity everolimus or other rapamycins or to its excipients. Patients with uncontrolled central nervous system (CNS) metastases. Patients receiving chronic systemic treatment with corticosteroids or another immunosuppressive agent. Patients with a known history of HIV seropositivity. Patients with autoimmune hepatitis. Patients with an active, bleeding diathesis. Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study. 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. Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods. Patients who are using other investigational agents or who had received investigational drugs ≤ 4 weeks prior to study treatment start. Patients unwilling to or unable to comply with the protocol.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Brussels
ZIP/Postal Code
BE-B-1200
Country
Belgium
Facility Name
Novartis Investigative Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Novartis Investigative Site
City
Bordeaux Cedex
ZIP/Postal Code
33075
Country
France
Facility Name
Novartis Investigative Site
City
Lyon Cedex
ZIP/Postal Code
69373
Country
France
Facility Name
Novartis Investigative Site
City
Marseille
ZIP/Postal Code
13273
Country
France
Facility Name
Novartis Investigative Site
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Novartis Investigative Site
City
Villejuif Cedex
ZIP/Postal Code
94805
Country
France
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
10098
Country
Germany
Facility Name
Novartis Investigative Site
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Novartis Investigative Site
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Novartis Investigative Site
City
Arezzo
State/Province
AR
ZIP/Postal Code
52100
Country
Italy
Facility Name
Novartis Investigative Site
City
Cremona
State/Province
CR
ZIP/Postal Code
26100
Country
Italy
Facility Name
Novartis Investigative Site
City
Pavia
State/Province
PV
ZIP/Postal Code
27100
Country
Italy
Facility Name
Novartis Investigative Site
City
Napoli
ZIP/Postal Code
80132
Country
Italy
Facility Name
Novartis Investigative Site
City
Otwock
ZIP/Postal Code
05-400
Country
Poland
Facility Name
Novartis Investigative Site
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08003
Country
Spain
Facility Name
Novartis Investigative Site
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08907
Country
Spain
Facility Name
Novartis Investigative Site
City
Valencia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46009
Country
Spain
Facility Name
Novartis Investigative Site
City
Barcelona
ZIP/Postal Code
08041
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
27680407
Citation
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.
Results Reference
derived

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

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