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NCT ID: NCT03525392 Terminated - Colorectal Cancer Clinical Trials

Study to Evaluate the Safety and Activity (Including Distribution) of 177Lu-3BP-227 in Subjects With Solid Tumours Expressing Neurotensin Receptor Type 1.

Start date: May 3, 2018
Phase: Phase 1
Study type: Interventional

This study was conducted to advance new treatment for patients with metastatic or locally advanced cancers expressing Neurotensin receptor 1 (NTSR1). This study was the first time the investigational drug called 177Lu-3BP-227 was administered to patients under controlled conditions of a clinical study. The purpose of this study was to evaluate how safe the investigational drug is as well to verify how well it is tolerated by patients after several intravenous administrations. In addition, the effect of the study drug on tumoral lesions and how it distributes throughout the body and at which rate it is removed from the body was evaluated. Since 177Lu-3BP-227 is a radio-labelled drug, it also measured how the emitted radiation is distributed throughout the body (dosimetry). The study consisted of a phase I dose escalation part. The study originally planned to include a phase II study however due to early termination (not due to safety concerns) the study did not progress to phase II and was stopped during phase I. For the phase I dose escalation part, it was anticipated that approximately 30 subjects will be included, in up to six escalation steps. No expansion cohorts were implemented.

NCT ID: NCT03525236 Completed - Cancer Clinical Trials

The Oncoflavour Study

Start date: June 19, 2017
Phase: N/A
Study type: Interventional

Oral nutritional supplements (ONS) are often prescribed for malnourished patients to help improve nutritional status. Commonly in cancer patients taste and smell alterations and side effects of treatment can affect the palatability and compliance to ONS. A variety of flavours and styles are available of ONS however research of the palatability of these in cancer patients is limited. This study aims to evaluate specific flavours created based on the taste changes occuring during treatment. We aim to evaluate the patient liking and evaluation of 5 flavors in 3 different types of flavour-sensations: - Warming/spicy sensation: to trigger the senses and bring new sensations - Cooling/fresh sensation: to have a fresh mouthfeel and lighter base perception - Neutral: to avoid that patients experience additional flavour and let them the opportunity to mix it with other food

NCT ID: NCT03524092 Active, not recruiting - Ulcerative Colitis Clinical Trials

A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis

LUCENT 2
Start date: October 19, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of mirikizumab as maintenance therapy in participants who completed as clinical responders in the prior 12-week induction study LUCENT-1 (NCT03518086).

NCT ID: NCT03523858 Active, not recruiting - Clinical trials for Progressive Multiple Sclerosis (PMS)

A Study to Evaluate Ocrelizumab Treatment in Participants With Progressive Multiple Sclerosis

CONSONANCE
Start date: May 28, 2018
Phase: Phase 3
Study type: Interventional

This study is a prospective, multicenter, open-label, single-arm effectiveness and safety study in participants with progressive multiple sclerosis (PMS).

NCT ID: NCT03523728 Terminated - Clinical trials for Polycystic Kidney, Autosomal Dominant

A Medical Research Study Designed to Determine if Venglustat Can be a Future Treatment for ADPKD Patients

STAGED-PKD
Start date: October 4, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

Primary Objective: To determine the effect of venglustat on the rate of total kidney volume (TKV) growth (Stage 1) and estimated glomerular filtration rate (eGFR) decline in participants at risk of rapidly progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD) (Stage 2). Secondary Objectives: - To determine the effect of venglustat on the rate of renal function decline (Stage 1) and on the rate of TKV growth (Stage 2). - To evaluate the pharmacokinetics (PK) of venglustat in ADPKD participants (Stages 1 and 2). - To determine the effect of venglustat on pain and fatigue, based on participant reported diary (Stages 1 and 2). - Safety/tolerability objectives: - To characterize the safety profile of venglustat (Stages 1 and 2). - To evaluate the effect of venglustat on mood using Beck Depression Inventory II (BDI-II) (Stages 1 and 2). - To evaluate the effect of venglustat on the lens by ophthalmological examination (Stages 1 and 2).

NCT ID: NCT03522142 Active, not recruiting - Clinical trials for Advanced Solid Tumors

A Study Exploring the Safety and Tolerability of INCB081776 in Participants With Advanced Malignancies

Start date: August 27, 2018
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics, and early clinical activity of single-agent INCB081776 (Part 1) and INCB081776 in combination with INCMGA00012 (Part 2).

NCT ID: NCT03521934 Terminated - Heart Failure Clinical Trials

Effect of Sotagliflozin on Cardiovascular Events in Participants With Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF Trial)

Start date: June 15, 2018
Phase: Phase 3
Study type: Interventional

Primary Objective: To compare the effect of sotagliflozin to placebo on the total occurrences of cardiovascular (CV) death, hospitalization for heart failure (HHF), and urgent visit for heart failure (HF) in hemodynamically stable participants after admission for worsening heart failure (WHF) Secondary Objectives: To compare the effects of sotagliflozin to placebo on: - The total occurrences of HHF and urgent visit for HF - The occurrence of CV death - The occurrence of all-cause mortality - The total occurrences of CV death, HHF, urgent visit for HF, non-fatal myocardial infarction (MI), and non-fatal stroke - Change in Kansas City Cardiomyopathy Questionnaire-12(KCCQ-12) score - Change in estimated glomerular filtration rate (eGFR)

NCT ID: NCT03521583 Recruiting - Clinical trials for Von Willebrand Disease

Von Willebrand Disease in the Netherlands

WiN-Pro
Start date: July 28, 2019
Phase:
Study type: Observational

The primary aim of this study is to prospectively investigate the current bleeding tendency of children and adults with VWD.

NCT ID: NCT03520634 Completed - Melanoma Clinical Trials

PD-L1 PET Imaging in Melanoma Patients

Start date: May 22, 2017
Phase: N/A
Study type: Interventional

This is a feasibility study for the use of [18F]PD-L1 as a PET tracer that will be conducted in a single center. The study consists of two phases. The aim of phase one is to provide pharmacokinetic information on the tracer and to determine the optimal time point for imaging. In the second phase the main study objective will be assessed.

NCT ID: NCT03519945 Recruiting - Ulcerative Colitis Clinical Trials

A Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 3)

Start date: July 18, 2018
Phase: Phase 3
Study type: Interventional

This study is designed to evaluate the long-term efficacy and safety of mirikizumab in participants with moderately to severely active ulcerative colitis (UC). The study will last up to 3 years. Participants who complete the 3-year study may continue to receive mirikizumab until it is (outside of this study) in their country or until they meet other discontinuation criteria.