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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01351571
Other study ID # ML25251
Secondary ID
Status Completed
Phase N/A
First received May 9, 2011
Last updated October 2, 2017
Start date August 2010
Est. completion date August 2011

Study information

Verified date October 2017
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This observational study will evaluate the safety and efficacy of Avastin (bevacizumab) in combination with interferon alpha-2a as first-line treatment in patients with advanced and/or metastatic renal cell carcinoma. Data will be collected from each patient as per routine clinical practice of the Investigator (maximum of 52 weeks, until disease progression /unacceptable toxicity or withdrawal of consent) and/or based on the local label.


Recruitment information / eligibility

Status Completed
Enrollment 5
Est. completion date August 2011
Est. primary completion date August 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adult patients, >/= 18 years of age

- Advanced and/or metastatic renal cell carcinoma

- Receiving first-line treatment with Avastin and interferon alpha-2a according to standard of care and current local label

- At least one measurable and non-measurable lesion according to RECIST criteria

- Eastern Cooperative Oncology Group (ECOG) performance status 0-2

- Adequate bone marrow, renal and liver function

Exclusion Criteria:

- Contraindications to Avastin and/or interferon alpha-2a as per local label

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety: Incidence of adverse events approximately 4 years
Secondary Progression-free survival: time from first drug administration to documented disease progression or death of any cause approximately 4 years
Secondary Overall response rate: complete response or partial response according to RECIST criteria approximately 4 years
Secondary Overall survival approximately 4 years
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