NCT01392729

Brief Summary

This prospective observational study will evaluate the efficacy and safety of Avastin (bevacizumab) in combination with interferon alpha 2a in patients with previously untreated metastatic renal cell cancer. Data will be collected from each patient for up to 4 years.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

September 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 12, 2011

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

4.8 years

First QC Date

July 11, 2011

Last Update Submit

November 1, 2016

Conditions

Renal Cell Cancer

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival

    approximately 4 years

Secondary Outcomes (3)

  • Overall survival

    approximately 4 years

  • Response rate

    approximately 4 years

  • Safety: Incidence of adverse events

    approximately 4 years

Study Arms (1)

Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with previously untreated metastatic renal cell cancer

You may qualify if:

  • Adult patients, \>/= 18 years of age
  • Histologically confirmed metastatic renal cell cancer, clear cell type
  • Eligible for treatment with Avastin and interferon alpha 2a according to local prescribing information

You may not qualify if:

  • Contraindications for Avastin or interferon alpha 2a treatment according to local Summary of Product Characteristics
  • Known hypersensitivity to Avastin and/or interferon alpha 2a or any of its excipients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Cluj-Napoca, 400015, Romania

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

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

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2011

First Posted

July 12, 2011

Study Start

September 1, 2010

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

RO(1)