check_circleStudy Completed

Carcinoma, Renal Cell

Bayer Identifier:

16091

ClinicalTrials.gov Identifier:

NCT01508364

EudraCT Number:

Not Available

EU CT Number:

Not Available
Nexavar as first targeted therapy in patients with advanced renal cell carcinoma

Trial purpose

This is an observational study which will investigate the use of Nexavar as first targeted therapy in patients with advanced renal cell carcinoma.

Key Participants Requirements

Sex

Both

Age

0 - N/A

  • - Patients with a diagnosis of advanced Renal cell carcinoma (RCC) for whom the decision has been taken by the investigator to prescribe Nexavar.
    - Patients who failed cytokine therapy or who are not suitable for cytokines for whom Nexavar is the first targeted drug treatment.

  • - Prior targeted therapy for RCC
    - Contraindications of Nexavar described in the Summary of Product Characteristics (SPC).

Trial summary

Enrollment Goal
20
Trial Dates
July 2012 - December 2013
Phase
N/A
Could I Receive a placebo
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Germany

Primary Outcome

  • Duration of Nexavar treatment
    date_rangeTime Frame:
    up to 3 years
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Overall Survival (OS)
    date_rangeTime Frame:
    1 - 1.5 years after LPLV
    enhanced_encryption
    Safety Issue:
    No
  • Health related quality of life (HRQoL)
    date_rangeTime Frame:
    up to 3 years
    enhanced_encryption
    Safety Issue:
    No
  • Progression-free survival (PFS)
    date_rangeTime Frame:
    up to 3 years
    enhanced_encryption
    Safety Issue:
    No
  • Tumor status, of patients will be evaluated according to the categories “Complete Response”, “Partial Response”, “Stable Disease”, “Clinical Progression”, “Radiological Progression”.
    date_rangeTime Frame:
    up to 3 years
    enhanced_encryption
    Safety Issue:
    No
  • Incidence of Treatment-emergent Adverse Events (TEAE)
    date_rangeTime Frame:
    up to 3 years
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

NEXTAR - NEXavar® as first TARgeted treatment for patients with advanced Renal Cell Carcinoma
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to Bayer Healthcare products.