Multi-Center Phase II Clinical Trial on Efficacy and Safety of Interferon Alfa-n1 + Sorafenib Combination Therapy in Renal Cell Carcinoma

Phase 2

• Conditions: Renal cell carcinoma

• Registration Number: JPRN-UMIN000002466
• Lead Sponsor: Japan RCC Trialist Collaborative Group (JRTCG)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-09-09
• Study Completion: 2013-07-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Not provided

Exclusion Criteria

1) Congestive cardiac failure 2) Severe arrhythmias 3) Active or symptomatic angina pectoris or coronary artery disease 4) Poorly controlled hypertension 5) History of HIV infection, or active chronic hepatitis caused by type B or type C hepatitis virus 6) Active infection 7) Intracranial metastasis 8) Convulsive disorders requiring treatment with anticonvulsants 9) History of organ transplant 10) Poorly controlled depression 11) Autoimmune hepatitis 12) History of malignant tumors 13) Radiation therapy, except for palliative therapy, within 3 weeks prior to the start of treatment 14) Significantly invasive surgery within 4 weeks prior to the start of treatment 15) Use of G-CSF within 3 weeks prior to the start of treatment 16) Pts with a history of treatment using drugs targeting VEGF or VEGF receptor 17) Pts with a history of treatment using Raf kinase, MEK, farnesyl transferase inhibitors 18) Pts being treated with adrenocortical steroids 19) Pts being treated with Minor Bupleurum Formula 20) Pts who have or have had interstitial pulmonary disease 21) Pregnant or nursing patients 22) Pts who are unable to practice appropriate contraception throughout the study period 23) Pts who abuse drugs or who have health conditions, psychological states, or social circumstances which would interfere with participation in the study or assessment of results 24) Pts with diseases or disability potentially affecting drug assessment 25) Patients who have had, or are suspected of having, allergies to sorafenib, Interferon Alfa-n1, or other interferon formulations 26) Pts with a history of hypersensitivity to biological preparations such as vaccines 27) Patients for whom oral medication may be difficult to take 28) Patients who previously encountered difficulties in treatment with IFN alfa due to adverse events caused by IFN alfa, or patients in whom IFN alfa-induced adverse events persist to this day

Study & Design

• Study Type: Interventional
• Study Design: Not specified