NCT02056587

Brief Summary

An estimated 10,000 metastatic renal cell carcinoma (RCC) patients receive first-line therapy in the Russian Federation. Bevacizumab (Avastin) in combination with interferon-alpha (IFN) is a recommended first-line treatment for metastatic RCC according to clinical recommendations of Russian Ministry of Health from 15.07.2010. Two randomized phase III trials (AVOREN, CALGB) showed that 50% of patients will progress on bevacizumab plus IFN within 8.5 - 10.2 months and will need sequential therapy. Everolimus (Afinitor) is a single agent which was evaluated and demonstrated efficacy in randomized phase III study (RECORD-1) in metastatic RCC patients after failure of targeted therapy. However, in this trial everolimus was compared with placebo for the treatment of patients whose disease had progressed on treatment with sunitinib or sorafenib (n=227). Only 9% (n=24) of patients received bevacizumab. Thus, efficacy data of everolimus in patients with disease progression on first-line bevacizumab is limited. Evaluating the effectiveness of everolimus in metastatic RCC patients with failure on bevacizumab with/without interferon alpha has a scientific and practical sense, and it is important for Russian Federation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2011

Geographic Reach
1 country

3 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

November 1, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 6, 2014

Completed
Last Updated

February 6, 2014

Status Verified

February 1, 2014

Enrollment Period

1.4 years

First QC Date

February 4, 2014

Last Update Submit

February 5, 2014

Conditions

Metastatic Renal Cell Carcinoma

Keywords

renal cell carcinomakidney cancerbevacizumab failureeverolimus

Outcome Measures

Primary Outcomes (1)

  • Primary endpoint is the proportion of progression-free patients for 2 months (based on results of a phase III study)

    2 months

Secondary Outcomes (4)

  • Median progression-free survival

    12 months

  • Median overall survival

    24 months

  • Response rate according to RECIST 1.1

    24 months

  • Treatment safety and tolerability according to NCI-CTCAE v.4.0

    24 months

Study Arms (1)

Everolimus

EXPERIMENTAL

All patients with metastatic renal cell carcinoma progressing on prior treatment with bevacizumab ± interferon enrolled into this study will receive everolimus in the dose of 10 mg daily until the disease progression or unacceptable toxicity.

Drug: Everolimus

Interventions

EverolimusDRUG

All patients with metastatic renal cell carcinoma progressing on prior treatment with bevacizumab ± interferon enrolled into this study will receive everolimus in the dose of 10 mg daily until the disease progression or unacceptable toxicity.

Everolimus

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically proven renal cell carcinoma
  • CT-confirmed measurable disease
  • Disease progression after bevacizumab +/- IFN
  • Favorable/intermediate prognosis according to MSKCC
  • Nephrectomy
  • No contradictions to everolimus
  • Age 18 or older
  • Written informed consent

You may not qualify if:

  • prior TKI's or mTOR inhibitor
  • pregnant or nursing
  • history of serious cardiac arrhythmia, congestive heart failure, angina pectoris, or other severe cardiovascular disease (i.e., New York Heart Association class III or IV)
  • CNS metastases by neurologic exam and/or MRI
  • local and/or systemic infections requiring antibiotics within 28 days prior to study entry
  • other malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Tatarstan Regional Cancer Center

Kazan', Tatarstan Republic, 420029, Russia

Location

Altai Regional Cancer Center

Barnaul, Russia

Location

N.N. Blokhin Russian Cancer Research Center

Moscow, 115478, Russia

Location

Related Publications (1)

  • Tsimafeyeu I, Snegovoy A, Varlamov S, Safina S, Varlamov I, Gurina L, Manzuk L. Everolimus in patients with metastatic renal cell carcinoma previously treated with bevacizumab: a prospective multicenter study CRAD001LRU02T. Target Oncol. 2015 Sep;10(3):423-7. doi: 10.1007/s11523-014-0347-4. Epub 2014 Dec 4.

    PMID: 25466382DERIVED

MeSH Terms

Conditions

Carcinoma, Renal CellKidney Neoplasms

Interventions

Everolimus

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2014

First Posted

February 6, 2014

Study Start

November 1, 2011

Primary Completion

April 1, 2013

Study Completion

October 1, 2013

Last Updated

February 6, 2014

Record last verified: 2014-02

Locations

RU(3)