NEWS HIGHLIGHTSMedia Articles Related to Nexavar (Sorafenib)
Nivolumab Approved for Liver Cancer Source: Medscape Gastroenterology Headlines [2017.09.25] The FDA has approved the immunotherapy for use in patients with hepatocellular carcinoma who have previously been treated with sorafenib. FDA Approvals
Published Studies Related to Nexavar (Sorafenib)
Sorafenib or placebo with either gemcitabine or capecitabine in patients with
HER-2-negative advanced breast cancer that progressed during or after
bevacizumab. [2013] CONCLUSION: The addition of sorafenib to gemcitabine/capecitabine provided a
Phase III trial of carboplatin and paclitaxel with or without sorafenib in
metastatic melanoma. [2013] metastatic melanoma... CONCLUSION: Sorafenib does not improve OS when given in combination with CP for
AMG 386 in combination with sorafenib in patients with metastatic clear cell
carcinoma of the kidney: a randomized, double-blind, placebo-controlled, phase 2
study. [2012] study... CONCLUSIONS: In patients with mRCC, AMG 386 plus sorafenib was tolerable but did
Sorafenib in locally advanced or metastatic breast cancer. [2012] INTRODUCTION: Sorafenib is an oral multikinase inhibitor with anti-angiogenic and
anti-proliferative activity that is indicated for use in hepatocellular and renal
cell carcinomas.The variability in results across studies with sorafenib may be related to the
chemotherapy combination and/or patient population.
Transarterial chemoembolization plus sorafenib: a sequential therapeutic scheme
for HCV-related intermediate-stage hepatocellular carcinoma: a randomized
clinical trial. [2012] CONCLUSION: A conventional TACE procedure followed by sorafenib treatment
Clinical Trials Related to Nexavar (Sorafenib)
Sorafenib With BIIB022 in Hepatocellular Carcinoma (HCC) [Completed]
This is a phase 1b, open-Label study of sorafenib with BIIB022 in subjects with advanced
hepatocellular carcinoma.
Phase I/II, Study of Selective Inhibitor of Nuclear Export (SINE) Selinexor (KPT-330) + Sorafenib in Acute Myeloid Leukemia [Not yet recruiting]
There are 2 parts to this study: Part 1 (dose escalation) and Part 2 (dose expansion).
The goal of Part 1 of this clinical research study is to find the highest tolerated dose of
the combination of selinexor (KPT-330) and sorafenib (Nexavar) that can be given to patients
with FLT3-ITD mutated AML or FLT3-mutated high-risk MDS.
The goal of Part 2 of this study is to learn if the dose found in Part 1 can help to control
the disease.
The safety of the drug combination will also be studied in both parts of this study.
Nexavar Post-marketing Surveillance for Renal Cell Carcinoma in Japan [Completed]
This study is a regulatory post-marketing surveillance in Japan, and it is a local
prospective and observational study of patients who have been administered with Nexavar for
unresectable or advanced renal cell carcinoma (RCC). The objective of this study is to
assess safety and effectiveness of Nexavar under real-life practice conditions. This study
is an all case investigation of which the enrollment period is 15 months, and all patients
who received Nexavar will be recruited and followed one year since starting Nexavar
administration.
Nexavar Post-marketing Surveillance for RCC in Japan: Early Access Program [Completed]
This study is an early access program of 'Nexavar post-marketing surveillance (PMS) for
renal cell carcinoma (RCC) in Japan' which is a regulatory, local prospective and
observational study for patients with unresectable or advanced RCC under real-life practice
conditions. The objective of this study is to assess safety and effectiveness of Nexavar at
some limited sites which joined to clinical trial of Nexavar, before available of it in the
market. The enrollment period is 2 months, and patients who received Nexavar will be
recruited and followed one year since starting Nexavar administration. The data of this
study will be integrated into the Nexavar PMS and the data will not be analyzed and reported
alone.
Nexavar Post-marketing Surveillance for Hepatocellular Carcinoma in Japan [Completed]
This study is a regulatory post-marketing surveillance in Japan, and it is a local
prospective and observational study of patients who have received Nexavar for unresectable
hepatocellular carcinoma (HCC). The objective of this study is to assess safety and
effectiveness of Nexavar under real-life practice conditions. This study is an all case
investigation of which the enrollment period is 2 or 3 months (dependent on sites) for
Child-Pugh A; for Child-Pugh B or C, the enrollment continues until agreement to stop with
Pharmaceuticals Medical Devices Agency (PMDA). All patients who have received Nexavar will
be recruited and followed one year since starting Nexavar administration.
Reports of Suspected Nexavar (Sorafenib) Side Effects
Diarrhoea (345),
Palmar-Plantar Erythrodysaesthesia Syndrome (282),
Fatigue (194),
Decreased Appetite (188),
Nausea (171),
Hepatic Neoplasm Malignant (164),
Pyrexia (143),
Rash (134),
Hypertension (132),
Ascites (126), more >>
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