Phase II study to investigate the efficacy, safety, and pharmacokinetics of sorafenib in Japanese patients with advanced renal cell carcinoma.

Phase II study to investigate the efficacy, safety, and pharmacokinetics of sorafenib in Japanese patients with advanced renal cell carcinoma. Research Abstract Details 

Research Abstract Table of Contents

Jump to the:

Phase II study to investigate the efficacy, safety, and pharmacokinetics of sorafenib in Japanese patients with advanced renal cell carcinoma. Abstract Text:

Hideyuki Akaza,Taiji Tsukamoto,Masaru Murai,Keiko Nakajima,Seiji Naito,

OBJECTIVE: Sorafenib (Nexavar) is an oral multi-kinase inhibitor that targets tumor growth and angiogenesis. This phase II study investigated efficacy, safety, and pharmacokinetics of sorafenib in Japanese patients with advanced renal cell carcinoma (RCC). METHODS: Nonrandomized, open-label study in Japanese patients with metastatic renal cell carcinoma who had received nephrectomy and failed >/=1 cytokine-containing therapy. The primary endpoint was response rate. Patients received sorafenib 400 mg twice daily (b.i.d.) on a continuous dosing schedule. RESULTS: A total of 129 patients (median age 63 years) were valid for intention-to-treat analyses. Confirmed partial responses were observed in 16 (12.4%) patients, and investigators assessed that 19 (14.7%) of the patients achieved a partial response. Stable disease was reported in 93 (72.1%) patients, and 103 (80.5%) patients had tumor shrinkage. Median progression-free survival was 224 days and the 25th percentile of overall survival was estimated at 288 days. The most frequently occurring drug-related adverse events (any grade) were elevated lipase (56%), hand-foot skin reaction (55%), alopecia (39%), increased amylase (38%), rash/desquamation (37%), and diarrhea (34%). A total of 14 (10.7%) patients had serious sorafenib-related adverse events, including one adverse event of worst grade 5 (dyspnea occurred 35 days after the last dose of study medication). The C(trough,steady state) values in RCC patients (n = 63) receiving sorafenib 400 mg b.i.d. were similar to those obtained from a Japanese phase I study involving patients with mixed solid tumors. CONCLUSION: Sorafenib showed encouraging efficacy and was well tolerated in Japanese patients with metastatic RCC.

Phase II study to investigate the efficacy, safety, and pharmacokinetics of sorafenib in Japanese patients with advanced renal cell carcinoma. Publishing Authors By Initials

H Akaza,T Tsukamoto,M Murai,K Nakajima,S Naito,

For similar abstracts research abstracts see: abstracts research

PUBMED ID PMID:

MEDLINE DATE:

Phase II study to investigate the efficacy, safety, and pharmacokinetics of sorafenib in Japanese patients with advanced renal cell carcinoma. Journal Published:

PUBLICATION TYPE: Research Support, Non-U.S. Gov

Journal: Japanese journal of clinical oncology

VOLUME: 37

Page Numbers: 755-62

Journal Abbreviation:

ISSN: 1465-3621

DAY: 19

MONTH: 10

YEAR: 2007

Phase II study to investigate the efficacy, safety, and pharmacokinetics of sorafenib in Japanese patients with advanced renal cell carcinoma. Information

Number of References:

LANGUAGE: eng

NlmUniqueID: 313225

Phase II study to investigate the efficacy, safety, and pharmacokinetics of sorafenib in Japanese patients with advanced renal cell carcinoma. Keywords Mesh Terms:

KEYWORDS:

MESH TERMS:

Chemical & Substance for Abstract: Phase II study to investigate the efficacy, safety, and pharmacokinetics of sorafenib in Japanese patients with advanced renal cell carcinoma. Information

Substance Name:

Registry Number:

Grant and Affiliation Information for Phase II study to investigate the efficacy, safety, and pharmacokinetics of sorafenib in Japanese patients with advanced renal cell carcinoma.

AFFILIATION: Department of Urology and Andrology, Graduate School of Comprehensive Human Science, University of Tsukuba, Tsukuba 305-8576, Japan. akazah@md.tsukuba.ac.jp

Country: Japan

AGENCY:

GRANT:

ACRONYM:

MEDLINETA: Jpn J Clin Oncol

REFSOURCE:

DATABASENAME:

ACCESSION NUMBER:

Number Hits: 0

Phase II study to investigate the efficacy, safety, and pharmacokinetics of sorafenib in Japanese patients with advanced renal cell carcinoma Related Publications

• A female case with Down syndrome and non-neurogenic neurogenic bladder.
• Angioplasty for non-arteriosclerotic renal artery stenosis: the efficacy of cutting balloon angioplasty versus conventional angioplasty.
• Anti-inflammatory and anti-oxidative properties of proton pump inhibitors.
• Associations of single nucleotide polymorphisms in the vascular endothelial growth factor gene with the characteristics and prognosis of renal cell carcinomas.
• Broadcast of live endoscopic surgery from Korea to Japan using the digital video transport system.
• Characteristics of type IV collagen unfolding under various pH conditions as a model of pathological disorder in tissue.
• Chromosome 20q13.2 gain may predict intravesical recurrence after nephroureterectomy in upper urinary tract urothelial tumors.
• Comparison of standard and hand-assisted laparoscopic radical nephrectomy for renal cell carcinoma.
• Cytological interface of diffusely infiltrating astrocytoma and its marginal tissue.
• Deciduoid mesothelioma in the pelvic cavity.
• Drowning deaths of U.S. Service personnel associated with motor vehicle accidents occurring in Operation Iraqi Freedom and Operation Enduring Freedom, 2003-2005.
• Dynamic aspects of extracellular loop region as a proton release pathway of bacteriorhodopsin studied by relaxation time measurements by solid state NMR.
• Effect of morpholino antisense oligonucleotide against lumican mRNA in human embryonic kidney (HEK) 293 cells.
• Fractional photothermolysis treatment for resistant melasma in Chinese females.
• Holmium laser for benign prostatic hyperplasia.
• Improvement of intraoperative frozen section diagnosis in patients with biliary strictures by levovist injection into the bile duct on color Doppler ultrasonography.
• Internet suicide in Japan: implications for child and adolescent mental health.
• Keratinocyte growth factor-transfection-stimulated adhesion of colorectal cancer cells to extracellular matrices.
• MRI artifact cancellation due to rigid motion in the imaging plane.
• Macrophage differentiation and function in health and disease.
• Meiotic Resumption of Porcine Immature Oocytes is Prevented by Ooplasmic Gsalpha Functions.
• Mos and the mitogen-activated protein kinase do not show cytostatic factor activity in early mouse embryos.
• NMR studies on fully hydrated membrane proteins, with emphasis on bacteriorhodopsin as a typical and prototype membrane protein.
• Organization of anterior cingulate and frontal cortical projections to the retrosplenial cortex in the rat.
• Phase II study to investigate the efficacy, safety, and pharmacokinetics of sorafenib in Japanese patients with advanced renal cell carcinoma.
• Role of lumican in cancer cells and adjacent stromal tissues in human pancreatic cancer.
• Sacral parasite with histopathological features of an unequally conjoined twin.
• The association of DNA repair gene polymorphisms with the development and progression of renal cell carcinoma.
• [Basic and clinical analysis of immune cell therapy against advanced renal cell carcinoma]
• [Motor unit number estimation in motor neuron disease]