A randomized, open-label, multi-center, phase II/III study on treatment with ABR-217620 combined with IFN-a vs. IFN-a alone in patients with advanced renal cell carcinoma. Protocol Version 1 dated 2006-10-06. Protocol Version 2 including Protocol Amendment 1 dated 2007-05-10. Protocol Version 3 including Protocol Amendment 2 dated 2007-11-07. Protocol Version 4 including Protocol Amendment 3 dated 2008-05-29.

Active Biotech Research AB0 sites524 target enrollmentFebruary 21, 2008

ConditionsRenal Cell Carcinoma MedDRA version: 9.1Level: LLTClassification code 10038413Term: Renal cell carcinoma stage III MedDRA version: 9.1Level: LLTClassification code 10038414Term: Renal cell carcinoma stage IV

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Renal Cell Carcinoma
Sponsor: Active Biotech Research AB
Enrollment: 524
Status: Active, not recruiting
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 21, 2008

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Active Biotech Research AB

Eligibility Criteria

Inclusion Criteria

•1\.Histologically or cytologically confirmed renal cell carcinoma (clear cell and papillary types). Biopsy of a metastasis is permitted if the primary tumor is inapproachable.
•2\.Metastatic or inoperable locally advanced renal cell cancer.
•3\.Patient must be eligible for therapy with IFN\-a.
•4\.Measurable disease defined by the presence of at least one measurable lesion documented on CT scan (lesion diameter \= 2\.0 cm measured by a standard (conventional) CT scanner or \= 1\.0 cm measured by a spiral CT scanner).
•5\.Favorable or moderate risk group prognosis by MSKCC (Motzer) criteria (score 0\-2\).
•6\.Karnofsky performance status \= 70\.
•7\.Age \= 18 years.
•8\.Life expectancy \> 3 months.
•9\.Patient has the following blood counts at baseline:
•absolute neutrophil count (ANC) \= 1\.5 x 109/L

Exclusion Criteria

•1\.Pregnant or breast\-feeding women are prohibited to take part in the study.
•2\.A serious uncontrolled medical disorder or active infection which are either ongoing or have resolved within 2 weeks before the first dose of the study treatment and which in the opinion of the investigator would impair the patient’s ability to receive the study treatment.
•3\.History of any malignancy within the past 5 years or any concurrent malignancy, with the exception of the following malignancies, which may still be included if successfully treated: non\-melanoma skin cancer, cervical cancer in situ, ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) of breast.
•4\.History and/or signs of parenchymal brain metastases.
•5\.Significant cardiac disease including: history (within the past 6 months) or current unstable angina pectoris, congestive heart failure of stage III\-IV (NYHA), or myocardial infarction within the past 12 months; or patients with uncontrolled arterial hypertension.
•6\.History of a stroke within the past 5 years and/or transient ischemic attack within the past 6 months.
•7\.Acute illness or evidence of infection, including unexplained fever (body temperature \> 100\.5 degrees F or 38\.1degrees C) within 2 weeks prior to start of treatment.
•8\.Treatment with beta\-blockers, excluding topical therapy for glaucoma, within 5 days prior to the start of the study treatment and during the 4 day ABR\-217620 treatment period.
•9\.Treatment with systemic corticosteroids within 2 weeks prior to the start of treatment or the patient will likely require such treatment throughout the study.
•10\.Active autoimmune disease requiring therapy or any history of systemic lupus erythematosis or rheumatoid arthritis.