Study Description. To collect characteristics of patients with ADPKD across a broad population, over time to better understand disease progression signs, symptoms and outcomes. Association with total kidney volume changes and other measures of disease progression will be determined in order to identify a population at increased risk for disease progression.
Subjects who terminated participation early from clinical trials with tolvaptan may also be followed.
Resource links provided by the National Library of Medicine MedlinePlus Genetics related topics: Congenital contractural arachnodactyly Kuskokwim syndrome Sheldon-Hall syndrome Distal arthrogryposis type 1 Polycystic kidney disease. MedlinePlus related topics: Kidney Diseases. FDA Resources. Outcome Measures.
Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Subjects will be identified by participating clinics primarily nephrology clinics treating patients with ADPKD. Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials. The number of patients experiencing at least one adverse event was similar in each treatment group, as was the number of patients experiencing adverse events of Grade 3 or higher. The OVATURE " OVA rian TU mor RE sponse" trial was a multi-center international Phase 3 clinical trial of orally administered investigational drug phenoxodiol in combination with carboplatin in women with advanced ovarian cancer resistant or refractory to platinum-based drugs to determine its safety and effectiveness when used in combination with carboplatin.
The trial recruited ovarian cancer patients whose cancer initially responded to chemotherapy, but had since become resistant or refractory to traditional platinum treatments. The study was closed to enrolment in April at which time patients had been randomized to the study. The Independent Data Monitoring Committee IDMC supported the Company's decision to close the study to accrual, and, in a review of the available safety data, the IDMC confirmed that there were no safety concerns with phenoxodiol in these subjects.
Phenoxodiol is being developed as a chemosensitizing agent in combination with platinum drugs for late stage, chemoresistant ovarian cancer and as a monotherapy for prostate and cervical cancers. It is believed to have a unique mechanism of action, binding to cancer cells via a cell membrane oxidase, causing major downstream disturbances in expression of proteins necessary for cancer cell survival and responsible for the development of drug resistance.
Phenoxodiol appears to selectively inhibit the regulator known as SP sphingosinephosphate that is overexpressed in cancer cells. In response to phenoxodiol, SP content is decreased, with a consequent decrease in expression of the pro-survival proteins XIAP and FLIP, inducing cell death via caspase expression and promoting sensitivity to other chemotherapeutics.
In laboratory studies, it has been demonstrated that drug-resistant ovarian cancer cells pre-treated with phenoxodiol were killed with lower doses of chemotherapy drugs. Importantly, phenoxodiol has been shown not to adversely affect normal cells in animal and laboratory testing. About phenoxodiol: Phenoxodiol is being developed as a chemosensitizing agent in combination with platinum drugs for late stage, chemoresistant ovarian cancer and as a monotherapy for prostate and cervical cancers.
It is believed to have a unique mechanism of action, binding to cancer cells via a cell membrane oxidase, causing major downstream disturbances in expression of proteins necessary for cancer cell survival and responsible for the development of drug resistance.
In cancer cells, phenoxodiol appears to selectively inhibit the regulator known as SP sphingosinephosphate that is overexpressed in cancer cells. In response to phenoxodiol, the SP content in cancer cells is decreased, with a consequent decrease in expression of the pro-survival proteins XIAP and FLIP, inducing cancer cell death via caspase expression and promoting sensitivity to other chemotherapeutics.
Indeed, in laboratory studies, it has been demonstrated that drug-resistant ovarian cancer cells pre-treated with phenoxodiol were killed with lower doses of chemotherapy drugs. Importantly, phenoxodiol has been shown not to adversely affect normal cells in animal and laboratory testing. Phenoxodiol has received Fast Track status from the FDA to facilitate its development as a therapy for recurrent ovarian and prostate cancers. Phenoxodiol is an investigational drug and, as such, is not commercially available.
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