NCT01715935

Brief Summary

Disease and Stage: Metastatic and locally advanced clear cell renal carcinoma An open-label, exploratory, single-arm, multicenter trial. Everolimus will be administered orally, once daily, for 6 weeks followed by a 1-week rest period prior to nephrectomy. Two to four weeks after surgery, everolimus will be reintroduced only for metastatic patients until disease progression, unacceptable toxicity, withdrawal of patient consent, or other stopping rules are met.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2012

Typical duration for phase_2

Geographic Reach
1 country

10 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

Study Start

First participant enrolled

June 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 29, 2012

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

August 19, 2016

Status Verified

February 1, 2016

Enrollment Period

3 years

First QC Date

September 12, 2012

Last Update Submit

August 18, 2016

Conditions

Clear-cell Renal CarcinomaClear-cell Metastatic Renal Cell Carcinoma

Keywords

Clear cells renal carcinomaeverolimusneo-adjuvant treatment

Outcome Measures

Primary Outcomes (1)

  • Objective clinical benefit

    Objective clinical benefit is defined as complete response, partial response or stable disease according to RECIST criteria version 1.1

    After 6 weeks of treatment

Secondary Outcomes (3)

  • Progression Free Survival

    up to 1 year

  • Overall survival

    up to 2 years

  • Safety and tolerability

    Participants will be followed all along the treatment period, an expected average of 15 months

Study Arms (1)

everolimus

EXPERIMENTAL

everolimus, 10 mg PO daily. Before nephrectomy: 6 continuous weeks of treatment and one week of rest After nephrectomy: 4 weeks courses (for metastatic patients only)

Drug: Everolimus

Interventions

EverolimusDRUG

everolimus, 10 mg PO daily. Before nephrectomy: 6 continuous weeks of treatment and one week of rest After nephrectomy: 4 weeks courses (for metastatic patients only)

Also known as: AFINITOR
everolimus

Eligibility Criteria

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

You may qualify if:

  • Advanced RCC or a resectable renal tumor and at least one measurable inoperable metastasis (at least 1 cm), in whom anti-angiogenic therapy is indicated
  • Patients without target lesions, with bone metastasis
  • Histologically confirmed clear cells RCC and possibility of adequate tumor sampling prior to treatment
  • No prior systemic treatment for RCC
  • Male or female, at least 18 years
  • PS ECOG 0-1
  • Life expectancy at least 3 months
  • Adequate organ function with the following criteria:
  • Total serum bilirubin equal or less than 2 x ULN (Gilbert's disease exempted)
  • Serum transaminases and alkaline phosphatases equal or less than 2.5 x ULN, or in case of liver or bone metastasis equal or less than 5x ULN
  • Serum creatinine equal or less than 2 x ULN, creatinine clearance at least 50 ml/min
  • Absolute neutrophil count (ANC) at least 1500/mm3
  • Platelets at least 100,000/mm3
  • Hemoglobin at least 10.0 g/dL
  • INR equal or less than 1.7 or prothrombin time (PT) equal or less than 6 sec
  • +6 more criteria

You may not qualify if:

  • Previous nephrectomy
  • Histology: any histologic type different than ccRCC
  • Treatment in a clinical trial in the last 30 days
  • Previous treatment with everolimus or other mTOR-inhibitors and anti-angiogenic drugs
  • Any of the following within 12 months prior to treatment initiation: severe/unstable angina, myocardial infarction, coronary artery bypass graft, symptomatic congestive heart failure, ischemic or hemorrhagic stroke including transient ischemic attack, abnormal lung function.
  • Uncontrolled hypertension defined as systolic blood pressure \>150 mmHg or diastolic pressure \>90 mmHg, despite optimal medical treatment
  • Abnormal ECG (Clinically significant)
  • Treatment with vitamin K antagonists. Ongoing treatment with therapeutic doses of coumarin derivative anticoagulants (e.g. warfarin) or treatment within the 2 weeks before the first day of everolimus administration. Prophylaxis with low dose warfarin for deep vein thrombosis is permitted (up to 2 mg/day). Low molecular weight heparin is allowed.
  • Brain metastasis. (Brain scan or MRI is mandatory). Note: Previous treated brain metastasis (surgery ± radiotherapy, radiotherapy, radiosurgery or gammaknife) and satisfying the following three criteria are allowed:
  • Asymptomatic;
  • No necessity of corticoid or antiepileptic treatment.
  • Pregnancy or breastfeeding.
  • Any second malignancy within the last 3 years with the exception of basal cell carcinoma, in situ cervical cancer and pT1/a bladder cancer with no evidence of recurrent disease for 12 months.
  • Clinically significant gastrointestinal abnormalities including but not limited to:
  • Malabsorption syndrome
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

CHRU Besançon

Besançon, 25000, France

Location

Hôpital Henri Mondor

Créteil, 94000, France

Location

Centre Hospitalier Départemental Vendée

La Roche-sur-Yon, 85925 cedex 9, France

Location

Hôpital Saint Eloi - CHU Montpellier

Montpellier, 34285 cedex 5, France

Location

Fôpital d'Instruction des Amées du Val de Grâce

Paris, 75005, France

Location

Hôpital Cochin

Paris, 75014, France

Location

Hôpital Européen Georges Pompidou - Service d'oncologie médicale

Paris, 7505, France

Location

Institut de Cancérologie Lucien Neuwirth

Saint-Priest-en-Jarez, 42270, France

Location

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, 54511, France

Location

Institut Gustave Roussy

Villejuif, 94805 cedex, France

Location

MeSH Terms

Conditions

Carcinoma, Renal CellClear-cell metastatic renal cell carcinoma

Interventions

Everolimus

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, 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

Study Officials

  • Stéphane Oudard, MD, PhD

    Hôpital Européen Georges Pompidou, Paris (France)

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 12, 2012

First Posted

October 29, 2012

Study Start

June 1, 2012

Primary Completion

June 1, 2015

Study Completion

April 1, 2016

Last Updated

August 19, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(10)