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NCT ID: NCT03851146 Completed - Advanced Cancer Clinical Trials

A Study of Anti-Lewis Y Chimeric Antigen Receptor-T Cells (LeY-CAR-T) in Patients With Solid Tumours

LeY-CAR-T
Start date: November 24, 2016
Phase: Phase 1
Study type: Interventional

This clinical trial is an open-label, single-centre, phase I study designed to investigate the safety and tolerability of a single infusion of autologous peripheral blood T-lymphocytes transduced with the anti-LeY-scFv-CD28-ΞΆ vector (LeY CAR T-cells) The primary aim of the trial is to evaluate the safety and tolerability of LeY CAR T cells in patients with Lewis Y antigen-expressing, advanced solid tumours. The secondary aim of the trial is to assess the anti-tumour activity of LeY CAR T cells in patients with LeY antigen-expressing, advanced solid tumours. Patients aged 18 years or older with advanced solid tumours have consented to pre-screening that allows their tumours to be assessed for LeY expression by immunohistochemistry. Patients whose tumours test positive for LeY were then able to proceed to eligibility screening and, if found to fulfil the eligibility criteria, were registered in the study. The study involves an initial dose escalation phase followed by an expansion phase.

NCT ID: NCT03850795 Active, not recruiting - Clinical trials for Prostate Cancer Metastatic

HC-1119 Versus Enzalutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Start date: March 15, 2021
Phase: Phase 3
Study type: Interventional

This study is a multinational Phase 3, randomized, double-blind, non-inferiority, efficacy and safety study of oral HC-1119 (80 mg/day) versus enzalutamide (160 mg/day) in asymptomatic or mildly symptomatic patients with progressive metastatic castration-resistant prostate cancer (mCRPC). The following assessment of prostate cancer status will be collected during the course of the trial: soft tissue disease on computed tomography (CT) scan or on magnetic resonance imaging (MRI), bone disease on radionuclide bone scans, FACT-P and EQ-5D, Brief Fatigue Inventory, and PSA. Throughout the study, safety and tolerability will be assessed by the recording of adverse events, monitoring of vital signs and physical examinations, safety laboratory evaluations, and 12-lead electrocardiograms (ECGs). Blood samples for population pharmacokinetics for HC-1119 and enzalutamide and related metabolites will be collected.

NCT ID: NCT03850782 Active, not recruiting - Ocular Hypertension Clinical Trials

Evaluation of the Duration of Effect of Bimatoprost SR in Participants With Open-Angle Glaucoma or Ocular Hypertension

Start date: February 28, 2019
Phase: Phase 3
Study type: Interventional

This study evaluates the duration of intraocular pressure (IOP)-lowering effect and safety of as needed administrations of Bimatoprost sustained release (SR) in participants with open-angle glaucoma (OAG) or ocular hypertension (OHT) who are not adequately managed with topical IOP-lowering medication for reasons other than medication efficacy.

NCT ID: NCT03850574 Recruiting - Clinical trials for Relapsed or Refractory Acute Myeloid Leukemia

Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Tuspetinib (HM43239) in Patients With Relapsed or Refractory Acute Myeloid Leukemia

APTIVATE
Start date: March 11, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

A Phase 1/2, Open-label, Multicenter, Dose Escalation and Expansion Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Tuspetinib (HM43239) in Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML)

NCT ID: NCT03850535 Terminated - Clinical trials for Acute Myeloid Leukemia

A Study Evaluating the Safety and Efficacy of Idasanutlin in Combination With Cytarabine and Daunorubicin in Patients Newly Diagnosed With Acute Myeloid Leukemia (AML) and the Safety and Efficacy of Idasanutlin in the Maintenance of First AML Complete Remission

Start date: March 25, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This Phase Ib/II, open-label, multicenter, non-randomized study will evaluate the safety, efficacy, and pharmacokinetics of idasanutlin when it is given in combination with cytarabine and daunorubicin in induction, in combination with cytarabine in consolidation, and as a single agent in maintenance for treating participants with acute myeloid leukemia (AML).

NCT ID: NCT03850483 Completed - Psoriasis Clinical Trials

Dose Ranging Study To Assess Efficacy, Safety and Tolerability Of PF-06700841 Topical Cream In Psoriasis

Start date: April 8, 2019
Phase: Phase 2
Study type: Interventional

This is a Phase 2b, randomized, double blind, vehicle controlled, parallel group, multicenter study in participants with mild to moderate plaque psoriasis. The duration of study participation will be approximately 22 weeks, including up to a 6 week screening period, 12 week treatment period, and approximately 4 week follow up period. Approximately 280 participants are planned to be randomized into the study.

NCT ID: NCT03850327 Completed - Atrial Fibrillation Clinical Trials

BIO|CONCEPT.BIOMONITOR III

Start date: March 8, 2019
Phase: N/A
Study type: Interventional

The objective of the study is to confirm the safety and efficacy of the BIOMONITOR III system. Furthermore, the insertion procedure, the use and handling of the incision and insertion tools and the sensing quality of the BIOMONITOR III will be assessed.

NCT ID: NCT03849716 Active, not recruiting - Dermatitis Atopic Clinical Trials

Evaluation of Biomarkers of Atopic Dermatitis in Pediatric Patients (PEDISTAD BIOMARKER STUDY)

Start date: April 5, 2019
Phase:
Study type: Observational [Patient Registry]

Primary Objective: To explore associations between biomarkers of atopic dermatitis (AD) and: - Disease state and time course of AD, - Disease state and evolution of selected atopic comorbid conditions, - Effectiveness of specific AD treatments.

NCT ID: NCT03849313 Completed - Healthy Volunteers Clinical Trials

Pharmacokinetics, Safety and Tolerability Study of AVT02 to EU-approved and US-licensed Humira (Adalimumab)

Start date: March 20, 2019
Phase: Phase 1
Study type: Interventional

This study has been designed as a multicentre, randomised, double-blind study of AVT02 in healthy adult subjects. The study will assess the PK, safety and tolerability of AVT02 compared to EU-Humira and US licenced Humira (US-Humira), when administered as a single 40 mg SC dose.

NCT ID: NCT03849118 Completed - Clinical trials for Clear Cell Renal Cell Carcinoma

89Zr-TLX250 for PET/CT Imaging of ccRCC- ZIRCON Study

89ZR-TLX250
Start date: August 15, 2019
Phase: Phase 3
Study type: Interventional

89Zr-TLX250 is under clinical development as a diagnostic agent targeting clear cell renal cell carcinoma.