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Continuous Dosing of BAY73-4506 in Patients With Advanced Malignancies

2014-08-27 03:13:54 | BioPortfolio

Summary

Continuous dosing of BAY73-4506 in patients with advanced cancer

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Conditions

Neoplasm

Intervention

Regorafenib (BAY73-4506), Regorafenib (BAY73-4506)

Location

Los Angeles
California
United States
90095

Status

Recruiting

Source

Bayer

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:54-0400

Clinical Trials [86 Associated Clinical Trials listed on BioPortfolio]

Phase I Study to Investigate Pharmacokinetics and Safety of BAY73-4506 in Asian (Japanese) Patients With Solid Tumors.

This study is to define the pharmacokinetics and to evaluate the safety of BAY73-4506, 160 mg once daily administered orally as a single agent in Japanese patients with advanced solid tumo...

Phase I Study of BAY73-4506 in Chinese Patients With Advanced, Refractory Solid Tumors

This will be an uncontrolled, open-label, non-randomized, phase I study. The primary objectives of this study are to define the pharmacokinetics (PK) and to evaluate the safety and tolerab...

Regorafenib Post-marketing Surveillance in Japan

The objective of this study is to assess safety and effectiveness of Regorafenib using in real clinical practice.

Pharmacokinetics and Safety of Regorafenib (BAY73-4506) in Cancer Subjects With Severe Renal Impairment

To characterize the pharmacokinetics and safety of regorafenib in cancer subjects with severe renal impairment when compared to the Control group (cancer subjects with normal or mildly imp...

Safety Study of BAY73-4506 in Patients With Hepatocellular Carcinoma

The purpose of this study is to determine whether BAY73-4506 treatment is safe and can shrink or delay the growth of tumors in patients with unresectable liver cancer.

PubMed Articles [331 Associated PubMed Articles listed on BioPortfolio]

FGFR2 amplification is predictive of sensitivity to regorafenib in gastric and colorectal cancers in vitro.

Although regorafenib has demonstrated survival benefits in patients with metastatic colorectal and gastrointestinal stromal tumors, no proven biomarker has been identified for predicting sensitivity t...

Topical administration of regorafenib eye drops: Phase I dose-escalation study in healthy volunteers.

Regorafenib is a multi-kinase inhibitor under investigation for use in neovascular age-related macular degeneration. In this Phase I study, regorafenib eye drops were administered to healthy volunteer...

Antitumor effects of regorafenib and sorafenib in preclinical models of hepatocellular carcinoma.

The purpose of this study was to investigate the antitumor activity of regorafenib and sorafenib in preclinical models of HCC and to assess their mechanism of action by associated changes in protein e...

Regorafenib-induced retinal and gastrointestinal hemorrhage in a metastatic colorectal cancer patient with liver dysfunction: A case report.

Regorafenib is effective for metastatic colorectal cancer but its toxicity such as hemorrhage should be considered. The safety of regorafenib for the patient with the liver disease is not known.

Serum CA19-9 Response Is an Early Predictive Marker of Efficacy of Regorafenib in Refractory Metastatic Colorectal Cancer.

Regorafenib improves survival in chemorefractory metastatic colorectal cancer (mCRC) patients. However, regorafenib induces various adverse events (AEs) that often impair patients' quality of life. Id...

Medical and Biotech [MESH] Definitions

Abnormal growths of tissue that follow a previous neoplasm but are not metastases of the latter. The second neoplasm may have the same or different histological type and can occur in the same or different organs as the previous neoplasm but in all cases arises from an independent oncogenic event. The development of the second neoplasm may or may not be related to the treatment for the previous neoplasm since genetic risk or predisposing factors may actually be the cause.

The local recurrence of a neoplasm following treatment. It arises from microscopic cells of the original neoplasm that have escaped therapeutic intervention and later become clinically visible at the original site.

Disappearance of a neoplasm or neoplastic state without the intervention of therapy.

The transfer of a neoplasm from one organ or part of the body to another remote from the primary site.

Methods which attempt to express in replicable terms the extent of the neoplasm in the patient.

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