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This study is to allow continued use of ribociclib (LEE011) as single agent or in combination with other investigational treatments in patients benefitting from treatment in an eligible Novartis-sponsored ribociclib (LEE011) study that has reached its primary objective(s) or has been halted for other reasons.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Continued Access to Study Treatment(s)
Not yet recruiting
Published on BioPortfolio: 2016-10-18T02:08:21-0400
Medtronic is sponsoring the Micra Continued Access (CA) study to provide continued access to the Micra System while the marketing application is under review by the Food and Drug Administr...
This study is for patients who have participated in a previous study and who continue to receive benefit to have continued access to study drug and/or treatment.
The purpose of this trial is to inform the future clinical development of the two investigational agents in ER+ breast cancer, LEE011 (CDK4/6 inhibitor) and BYL719 (PI3K-alpha inhibitor). ...
This is a Phase I study to assess the safety and MTD of paclitaxel + ribociclib (LEE011) in patients with Rb+, advanced breast cancer. Dose escalation will be performed using standard 3 + ...
This study is a single-arm, open-label, multi-institutional Phase I/II trial of the combination of LEE011 and everolimus in refractory mPAC.
Treatment interruption (TI) has been safe and durable in some pediatric studies but none have compared TI to continued antiretroviral treatment (ART) following ART initiation in early HIV. The objecti...
Universal access implies that all tuberculosis (TB) patients in the community should have access to early, good quality diagnosis and treatment services that are affordable and convenient to the patie...
Common mental disorders like mood and anxiety disorders and somatoform disorders have high costs, yet under-treatment is still frequent. Many people with common mental disorders are employed, so the w...
Strong socioeconomic inequalities exist in cardiovascular mortality and morbidity. The current review aims to synthesize the current evidence on the association between socioeconomic status (SES) and ...
The objective of the present study was to evaluate the clinical effectiveness and safety of the local application of triderm for the treatment of diffuse external otitis. The study included 68 patient...
A surgical specialty concerned with the study and treatment of disorders of the ear, nose, and throat.
Providing an investigational therapy to a patient who is not eligible to receive that therapy in a clinical trial, but who has a serious or life-threatening illness for which other treatments are not available. Compassionate use trials allow patients to receive promising but not yet fully studied or approved therapies when no other treatment option exists. Also called expanded access trial.
Data collected during dental examination for the purpose of study, diagnosis, or treatment planning.
The study and treatment of human behavior problems utilizing principles derived from the behavioral, medical, and social science with emphasis on promotion of mental health.
Differences in access to or availability of facilities and services
Alliances Astrazeneca Bioethics Boehringer Clinical Research Organization Collaborations GSK Johnson & Johnson Lilly Merck Mergers and Acquisitions Nexium Novartis Pfizer Roche Sanofi ...
Novartis is the fourth largest pharmaceutical company in the world, based on annual sales, which are exceeded $36,000m in 2009. Founded in 1996, Novartis focuses of four main areas; pharmaceuticals, vaccines & diagnostics, generic medicines and biosi...