PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT03775538: Safety of CDNF by Brain Infusion in Patients With Parkinson's Disease. Extension to HP-CD-CL-2002 Clinical Study
Official title: A Randomised, Double-Blind, Multi-centre, Active Treatment, Extension and Safety Study for Patients With Idiopathic Parkinson's Disease (PD) Who Previously Completed the CDNF/DDS Main Study HP-CD-CL-2002
Conditions: Parkinson Disease
Movement Disorders
Neuro-Degenerative Disease
Nervous System Diseases
Brain Diseases
Summary: This study is an extension to the HP-CD-CL-2002 clinical study. It evaluates the long-term safety and tolerability of CDNF in patients with Parkinson's disease when dosed directly into the brain using an implanted investigational drug delivery system (DDS). Long-term safety of the DDS is also being evaluated. All patients will receive monthly infusions of either mid- or high-dose of CDNF for a period of 6 months.
Interventions:
description: Repeated intracerebral infusions
name: Cerebral Dopamine Neurotrophic Factor
other_name: CDNF
type: Drug
description: Stereotactically implanted device
name: Renishaw Drug Delivery System
other_name: DDS
type: Device
Study arms:
design_group_description: Patients randomized to this group will receive 6 monthly-intermittent intracerebral doses of Cerebral Dopamine Neurotrophic Factor (CDNF) titrated to mid-dose (400 micrograms) administered via the Renishaw Drug Delivery System (DDS) to the bilateral putamen.
design_group_title: CDNF mid-dose (400 micrograms)
design_group_type: Experimental
design_group_description: Patients randomized to this group will receive 6 monthly-intermittent intracerebral doses of Cerebral Dopamine Neurotrophic Factor (CDNF) titrated to high-dose (1200 micrograms) administered via the Renishaw Drug Delivery System (DDS) to the bilateral putamen.
design_group_title: CDNF high-dose (1200 micrograms)
design_group_type: Experimental
Sponsor: Herantis Pharma Oyj
Collaborators: Renishaw Plc
Drug name mappings:
name: Cerebral dopamine neurotrophic factor(University of Helsinki)
lang: EN
Clinical trial NCT07164976: Ribociclib for HR-positive HER2-negative Metastatic Breast Cancer
Official title: Phase Ib/II Trial of Ribociclib Plus Anastrozole in Patients With Hormone Receptor-Positive, HER2-Negative Metastatic or Recurrent Breast Cancer
Conditions: Breast Cancer
Summary: This document outlines an investigator-initiated Phase Ib/II clinical trial in Japan, focusing on the combination therapy of ribociclib and anastrozole for patients with hormone receptor-positive (HR-positive), HER2-negative metastatic or recurrent breast cancer. The trial aims to evaluate the efficacy (specifically, overall response rate) and safety of this combination in the Japanese patient population. Nagoya City University is the sponsor of this trial, with funding provided by Novartis Pharma K.K..
Study Design and Endpoints: The trial is structured into two parts:
* Phase Ib: The primary endpoint for this phase is tolerability, which is assessed by dose-limiting toxicities (DLT). Secondary endpoints include pharmacokinetics (PK) of the drugs, as well as the incidence of adverse events (AE) and serious adverse events (SAE).
* Phase II: The primary endpoint for Phase II is the Overall Response Rate (ORR), which will be determined by a blinded central imaging review based on RECIST version 1.1 criteria. Secondary endpoints encompass PK (for the initial 20 patients), ORR as assessed by the investigator, progression-free survival (PFS), overall survival (OS), and the overall incidence of adverse events
Interventions:
description: phase 1b cohort 1
name: Ribociclib 400mg
type: Drug
description: Phase 1b cohort 2
name: Ribociclib 600mg
type: Drug
description: phase 2
name: Ribociclib 600mg
type: Drug
Study arms:
design_group_description: phase 1b cohort 1
design_group_title: phase 1b cohort 1
design_group_type: Experimental
design_group_description: phase 1b cohort 2
design_group_title: phase 1b cohort 2
design_group_type: Experimental
design_group_title: phase 2 part
design_group_type: Experimental
Sponsor: Nagoya City University
Collaborators: Novartis AG
Drug name mappings:
name: 琥珀酸瑞波西利
lang: CN
name: Ribociclib Succinate
lang: EN