NCT01982097

Brief Summary

This local, prospective, multicenter, non-interventional study documents observational data on patients under routine treatment of metastatic RCC with Nexavar before and after cytoreductive nephrectomy. It's planned to better understand the impact of cytoreductive nephrectomy on Nexavar efficacy and possibly to define patients who get the most benefit from Nexavar before cytoreductive nephrectomy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2014

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

First Submitted

Initial submission to the registry

November 6, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 13, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

January 10, 2014

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2017

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2017

Completed
Last Updated

February 7, 2018

Status Verified

February 1, 2018

Enrollment Period

3.1 years

First QC Date

November 6, 2013

Last Update Submit

February 6, 2018

Conditions

Carcinoma, Renal Cell

Keywords

Non-interventionalNexavarSorafenibCarcinoma, renal cellNeoadjuvantNephrectomyRussian Federation

Outcome Measures

Primary Outcomes (2)

  • Maximum percent reduction (based on the minimum post baseline value) in the longest diameter of the primary tumor in response to neoadjuvant Nexavar treatment.

    up to 2 years

  • Response rate of residual disease to Nexavar according to RECIST 1.1 with baseline after cytoreductive nephrectomy.

    up to 2 years

Secondary Outcomes (4)

  • Response before cytoreductive nephrectomy according to RECIST 1.1.

    up to 2 years

  • Maximum percent reduction in the sum of longest diameters of target lesions according to RECIST 1.1 while on Nexavar treatment before cytoreductive nephrectomy

    up to 2 years

  • Maximum percent reduction in the sum of longest diameters of target lesions of residual disease after cytoreductive nephrectomy according to RECIST 1.1 while on Nexavar treatment with baseline after cytoreductive nephrectomy.

    up to 2 years

  • Number of participants with AEs, including intra- and postoperative complications, relation to Nexavar treatment, AEs treatment, AEs outcome.

    up to 2 years

Study Arms (1)

Group 1

Drug: Sorafenib (Nexavar, BAY 43-9006)

Interventions

Sorafenib (Nexavar, BAY 43-9006)DRUG

The patients under routine treatment of metastatic RCC with Nexavar before and after cytoreductive nephrectomy meeting the criteria of inclusion.

Group 1

Eligibility Criteria

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

Male and female patients ≥ 18 years old with untreated metastatic RCC for whom treatment with Nexavar is planned with subsequent cytoreductive nephrectomy and resumption of Nexavar in case of clinical feasibility

You may qualify if:

  • \- Male and female patients ≥ 18 years old
  • Patients with untreated metastatic RCC in whom a decision on neoadjuvant treatment with Nexavar before cytoreductive nephrectomy and in case of clinical feasibility resumption of treatment with Nexavar after nephrectomy has been made at the time of study enrollment
  • Life expectancy of at least 16 weeks
  • Patients should have signed informed consent form

You may not qualify if:

  • Diagnosis of any second malignancy within the last 5 years, except for adequately treated basal cell carcinoma, squamous cell skin cancer, or in situ cervical cancer.
  • All contra-indications according to the Russian marketing authorization:
  • Hypersensitivity to sorafenib or to any of the excipients.
  • Pregnancy and breast-feeding.
  • Age less than 18 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Multiple Locations, Russia

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Sorafenib

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)

Phenylurea CompoundsUreaAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNiacinamideNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

November 6, 2013

First Posted

November 13, 2013

Study Start

January 10, 2014

Primary Completion

January 31, 2017

Study Completion

December 7, 2017

Last Updated

February 7, 2018

Record last verified: 2018-02

Locations

RU(1)