NCT00688753

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2009

Longer than P75 for phase_2

Geographic Reach
6 countries

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 3, 2008

Completed
1.1 years until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

November 26, 2015

Completed
Last Updated

September 2, 2016

Status Verified

July 1, 2016

Enrollment Period

5.3 years

First QC Date

May 30, 2008

Results QC Date

October 21, 2015

Last Update Submit

July 26, 2016

Conditions

CarcinomaRenal CellNon Clear Cell Renal CarcinomaPapillary Cell Renal CarcinomaAdenocarcinoma

Keywords

renal cell carcinomanon clear cell carcinomapapillary cell renal carcinomaadultseverolimus

Outcome Measures

Primary Outcomes (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.

    PFSR at 6 months based on central review

    6 mos

Secondary Outcomes (5)

  • Disease Control Rate (SD + PR + CR)

    6 mos

  • Objective Response Rate

    End of trial

  • Duration of Response

    End of trial

  • Median Progression Free Survival

    End of trial

  • Incidence of Adverse Events, Serious Adverse Events, and Death.

    End of trial

Study Arms (1)

RAD001

EXPERIMENTAL

two 5 mg tablets of everolimus orally, once daily

Drug: RAD001

Interventions

RAD001DRUG
RAD001

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Novartis Investigative Site

Brussels, BE-B-1200, Belgium

Location

Novartis Investigative Site

Ghent, 9000, Belgium

Location

Novartis Investigative Site

Bordeaux, 33075, France

Location

Novartis Investigative Site

Lyon, 69373, France

Location

Novartis Investigative Site

Marseille, 13273, France

Location

Novartis Investigative Site

Paris, 75015, France

Location

Novartis Investigative Site

Villejuif, 94805, France

Location

Novartis Investigative Site

Berlin, 10098, Germany

Location

Novartis Investigative Site

Hanover, 30625, Germany

Location

Novartis Investigative Site

Münster, 48149, Germany

Location

Novartis Investigative Site

Arezzo, AR, 52100, Italy

Location

Novartis Investigative Site

Cremona, CR, 26100, Italy

Location

Novartis Investigative Site

Pavia, PV, 27100, Italy

Location

Novartis Investigative Site

Napoli, 80132, Italy

Location

Novartis Investigative Site

Otwock, 05-400, Poland

Location

Novartis Investigative Site

Barcelona, Barcelona, 08041, Spain

Location

Novartis Investigative Site

Barcelona, Catalonia, 08003, Spain

Location

Novartis Investigative Site

Barcelona, Catalonia, 08907, Spain

Location

Novartis Investigative Site

Valencia, Valencia, 46009, Spain

Location

Related Publications (1)

  • 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.

    PMID: 27680407DERIVED

MeSH Terms

Conditions

CarcinomaCarcinoma, Renal CellAdenocarcinoma

Interventions

Everolimus

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic Chemicals

Results Point of Contact

Title
Clinical Disclosure Office
Organization
Novartis Pharmaceuticals
862-778-8300

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2008

First Posted

June 3, 2008

Study Start

July 1, 2009

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

September 2, 2016

Results First Posted

November 26, 2015

Record last verified: 2016-07

Locations

IT(4)PL(1)ES(4)FR(5)DE(3)BE(2)