NEWS HIGHLIGHTSMedia Articles Related to Nexavar (Sorafenib)
Seattle Genetics Initiates Phase I Clinical Trial Of Antibody-Drug Conjugate SGN-75
Source: Urology / Nephrology News From Medical News Today [2009.11.18]
Seattle Genetics, Inc. (Nasdaq: SGEN) announced that it has initiated a phase I clinical trial of SGN-75 for metastatic renal cell carcinoma and relapsed and refractory non-Hodgkin lymphoma. SGN-75 is an antibody-drug conjugate (ADC) targeting CD70 that utilizes the company's proprietary technology.
Published Studies Related to Nexavar (Sorafenib)
Sorafenib for treatment of renal cell carcinoma: Final efficacy and safety results of the phase III treatment approaches in renal cancer global evaluation trial. [2009.07.10]
PURPOSE: Mature survival data and evaluation of vascular endothelial growth factor (VEGF) as a prognostic biomarker from the Treatment Approaches in Renal Cancer Global Evaluation Trial (TARGET) study in patients with renal cell carcinoma (RCC) are reported... CONCLUSION: Although an OS benefit was not seen on a primary intent-to-treat analysis, results of a secondary OS analysis censoring placebo patients demonstrated a survival advantage for those receiving sorafenib, suggesting an important cross-over effect. VEGF levels are prognostic for PFS and OS in RCC. The results of TARGET establish the efficacy and safety of sorafenib in advanced RCC.
Sorafenib tosylate in advanced kidney cancer: past, present and future. [2009.07]
The objective of this paper was to review the development of sorafenib tosylate in kidney cancer. The MedLine database, the Proceedings of the Annual American Society of Clinical Oncology meeting, as well as those of other key international meetings were extensively searched to identify relevant publications...
Results of a phase III, randomized, placebo-controlled study of sorafenib in combination with carboplatin and paclitaxel as second-line treatment in patients with unresectable stage III or stage IV melanoma. [2009.06.10]
PURPOSE: This phase III, randomized, double-blind, placebo-controlled study was conducted to evaluate the efficacy and safety of sorafenib with carboplatin and paclitaxel (CP) in patients with advanced melanoma who had progressed on a dacarbazine- or temozolomide-containing regimen... CONCLUSION: In this study, the addition of sorafenib to CP did not improve any of the end points over placebo plus CP and cannot be recommended in the second-line setting for patients with advanced melanoma. Both regimens had clinically acceptable toxicity profiles with no unexpected adverse events. A trial of similar design for the first-line treatment of patients with advanced melanoma (intergroup trial E2603) is currently ongoing.
Randomized phase II trial of first-line treatment with sorafenib versus interferon Alfa-2a in patients with metastatic renal cell carcinoma. [2009.03.10]
PURPOSE: An open-label, phase II study to evaluate progression-free survival (PFS), overall best response, adverse events (AEs), and patient-reported outcomes with sorafenib versus interferon alfa-2a (IFN-alpha-2a) in patients with untreated, advanced renal cancer... CONCLUSION: In this study, sorafenib resulted in similar PFS as IFN-alpha-2a in patients with untreated RCC. However, sorafenib-treated patients experienced greater rates of tumor size reduction, better QOL, and improved tolerability. Both dose escalation of sorafenib after progression and a switch to sorafenib after progression on IFN-alpha-2a resulted in clinical benefit.
[Palliative management of hepatocarcinoma with sorafenib (Nexavar). Results of the SHARP study (sorafenib hepatocarcinoma assessment randomized protocol trial)] [2009.03]
Curative management of early-stage hepatocarcinoma may include partial hepatic resection, liver transplantation or tumoral necrosis using radiofrequency ablation or alcoholisation. Until recently, no efficient therapeutic mean was available for advanced hepatocarcinoma... Another future evaluation could be the association of sorafenib with other antitumoral agents.
Clinical Trials Related to Nexavar (Sorafenib)
Study Comparing Association Between Sorafenib and Interleukin-2 (IL-2) Versus Sorafenib in 1st Line Therapy in Advanced (Adv.) Renal Cell Carcinoma (RCC) [Completed]
The ROSORC trial is a randomized study comparing the efficacy of a new association (sorafenib
and IL-2) versus the standard therapy (sorafenib) in patients affected by different
histotypes of metastatic RCC. This study is a first line therapy for the advanced disease.
The primary objective is the progression free survival (PFS) in the 2 arms of therapy and the
secondary objective is the overall survival (OS) and the response rate (RR) and the safety
profile of the combination comparing to sorafenib alone.
BAY 43-9006 (Sorafenib) Versus Interferon Alpha-2a in Patients With Unresectable and/or Metastatic Renal Cell Carcinoma [Active, not recruiting]
The purpose of the study is to:
- Find out if patients receiving BAY 43-9006 will live longer without tumor progression
than those receiving standard therapy with interferon alpha-2a
- Find out if a higher dose of BAY 43-9006 can inhibit tumor progression in patients who
progressed during standard dose treatment with BAY 43-9006, and for how long these
patients live without progression
- Find out how long patients live without progression who receive BAY 43-9006 after
failing to respond to standard therapy with interferon alpha-2a
- Find out in how many percent of patients BAY 43-9006 prevents the growth of or shrinks
kidney tumors and/or their metastases depending on treatment and dosage
- Find out if BAY 43-9006 has any effect on the quality of life of patients with kidney
cancer
- Find out the level of BAY 43-9006 in the blood once per month and any changes in this
level
- Find out whether Bay 43-9006 effects are associated with specific biomarkers
Sorafenib in Resected Non-Small Cell Lung Carcinoma [Active, not recruiting]
This is an open-label, single-armed, multicentric, phase II study of Sorafenib treatment
following surgery for NSCLC.
The primary hypothesis is to increase the progression-free survival (PFS) of the experimental
group in comparison to a historical control group. For sample size calculation a 2 year PFS
of 50% was calculated for the historical control group, and a 2 year PFS of 67% was estimated
for the intervention group. These estimates are based on the actual PFS and overall survival
(OS) of a defined population of 120 NSCLC patients treated at a single institution with
surgery alone or surgery followed by adjuvant radiotherapy, which compares favorably to
published international results, and the improvement of PFS achieved by 4 cycles of
cisplatin/vinorelbine-based cytotoxic chemotherapy in published randomized trials.
Phase III Study of BAY 43-9006 in Japanese Patients With Advanced Hepatocellular Carcinoma [Active, not recruiting]
Clinical trial of BAY 43-9006 in Japanese patients with hepatocellular carcinoma.
Extension Program for Bay 43-9006 [Completed]
The study was designed to allow for the continuation of treatment with Sorafenib as a single
agent to those patients who participated in a previous Sorafenib study that had reached its
designated end-date and who were, in the opinion of the Investigator and the Sponsor, still
benefiting from treatment.
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