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Results 551 - 554 of 554

Phase III Study of Trastuzumab Deruxtecan (T-DXd) with or without Pertuzumab versus Taxane, Trastuzumab and Pertuzumab in HER2-positive, First-line Metastatic Breast Cancer (DESTINY-Breast09)

Recruitment Status
Pending
Project Status
Ongoing
Project Description
This is a Phase III, randomised, three-arm, multi-centre, global study assessing the efficacy and safety of T-DXd with or without pertuzumab (blinded for pertuzumab in the T-DXd arms) compared with SoC THP (taxane, trastuzumab and pertuzumab) as first-line treatment in participants with HER2-posi . . .
Primary Sponsor
AstraZeneca AB
Study Type
Interventional
Date of Registration
06 July 2021
Date of FIrst Enrollment
29 July 2021
Region
Sweden
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Not Applicable
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2021-CT0606
Sources of Monetary or Material Support
AstraZeneca AB
Primary Outcomes

To assess the efficacy of T-DXd ± pertuzumab compared with THP in terms of PFS according to BICR in participants with HER2-positive, first-line mBC.

Key Inclusion and Exclusion Criteria
Age 1 Participant must be ≥ 18 years at the time of screening (≥ 20 years for participants enrolled in Japan). Type of Participant and Disease Characteristics 2 Pathologically documented breast cancer that:   (a) Is advanced or metastatic (participants who can . . .
Countries of Recruitment
Argentina, Austria, Belgium, Brazil, Canada, China, Denmark, France, Germany, Hungary, India, Italy, Japan, Mexico, Peru, Philippines, Romania, Russia, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Taiwan, Turkey, United Kingdom, United States
Health Condition(s) or Problem(s) Studied

Metastatic Breast Cancer


A global multicenter, randomized, double-blind, placebo-controlled, phase III clinical trial to evaluate the efficacy, safety, and immunogenicity of recombinant COVID-19 vaccine (Sf9 cells), for the prevention of COVID-19 in adults aged 18 years and older

Recruitment Status
Pending
Project Status
Ongoing
Project Description
This is a Phase III study in a global multicentre, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy, safety and immunogenicity of the Recombinant COVID-19 Vaccine cells (Sf9 cells) produced by WestVac Biopharma Co., Ltd in the 5,000 participants/subject who wil . . .
Primary Sponsor
WestVac Biopharma Co., Ltd and West China Hospital of Sichuan University
Study Type
Interventional
Date of Registration
12 July 2021
Date of FIrst Enrollment
30 July 2021
Region
China
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Parallel
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2021-CT0616
Sources of Monetary or Material Support
WestVac Biopharma Co., Ltd.
Primary Outcomes
1. Primary Efficacy Virologically confirmed (PCR positive) symptomatic COVID-19 cases first occurring ﹥28 days after completion of 3 doses vaccination, regardless of severity 2. Primary Safety SAEs from Day 0 through 6 months after completion of 3 d . . .
Key Inclusion and Exclusion Criteria
Inclusion Criteria Aged 18 years and older Able and willing (in the investigator’s opinion) to comply with all study requirements. Willing to allow the investigators to discuss the volunteer’s medical history with their general practitioner/ . . .
Countries of Recruitment
Philippines, Austria, Belgium, Brazil, Canada, China, Denmark, France, Germany, Hungary, India, Italy, Japan, Mexico, Peru, Philippines, Romania, Russia, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Taiwan, Turkey, United Kingdom, United States
Health Condition(s) or Problem(s) Studied

Prevention of COVID-19 caused by infection with the SARS-CoV-2.


A Study of Guselkumab in Participants with Active Psoriatic Arthritis

Recruitment Status
Pending
Project Status
Pending
Project Description
This is a Phase 3b, multicenter, randomized, double-blind, placebo-controlled, 3-arm study in participants with active psoriatic arthritis (PsA) who are biologic naive and have had inadequate response to current standard therapies (eg, disease-modifying antirheumatic drugs [DMARDs]/apremilast, co . . .
Primary Sponsor
Janssen Research and Development LLC
Secondary Sponsor
PAREXEL Clinical Research (Philippines) Ltd. Corp.
Study Type
Interventional
Date of Registration
08 July 2021
Date of FIrst Enrollment
01 September 2021
Region
United States of America
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Parallel
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2021-CT0619
Sources of Monetary or Material Support
Janssen Research and Development LLC
Primary Outcomes

Outcome Measure: Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24

Timeframe: Week 24

Key Inclusion and Exclusion Criteria
Inclusion Criteria: - Have active psoriatic arthritis (PsA) despite previous non-biologic disease-modifying antirheumatic drug (DMARD), apremilast, and/or nonsteroidal anti-inflammatory drug (NSAID) therapy - Have a diagnosis of PsA for at least 6 months before th . . .
Countries of Recruitment
Australia, Belarus, Bosnia and Herzegovina, Bulgaria, Canada, Croatia, Czech Republic, Estonia, Georgia, Germany, Hungary, Israel, Italy, Latvia, Lithuania, Philippines, Poland, Russia, Serbia, Slovenia, Spain, Taiwan, Ukraine, United States, Turkey, United Kingdom, United States
Health Condition(s) or Problem(s) Studied

Active Psoriatic Arthritis


Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy for Locally Recurrent Inoperable or Metastatic Breast Cancer (MK-3475-B49/KEYNOTE-B49)

Recruitment Status
Pending
Project Status
Pending
Project Description
The safety and efficacy of pembrolizumab plus the investigator's choice of chemotherapy will be assessed compared to placebo plus the investigator's choice of chemotherapy in the treatment of chemotherapy-candidate hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/ . . .
Primary Sponsor
Merck Sharp & Dohme (I.A.) LLC
Secondary Sponsor
Merck Sharp & Dohme (I.A.) LLC
Study Type
Interventional
Date of Registration
21 July 2021
Date of FIrst Enrollment
15 August 2021
Region
NCR
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Parallel
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2021-CT0615
Sources of Monetary or Material Support
Merck Sharp & Dohme (I.A.) LLC
Primary Outcomes
1. Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With Combined Positive Score (CPS) ≥10 [ Time Frame: Up to approximately 33 months ]PFS is defined as the time from randomizati . . .
Key Inclusion and Exclusion Criteria
Inclusion Criteria: Has locally recurrent inoperable or metastatic HR+/HER2- breast cancer, which has not been previously treated with cytotoxic chemotherapy in the noncurative setting Has progressed on 2 or more li . . .
Countries of Recruitment
, Argentina, Australia, Austria, Canada, Chile, China, France, Germany, Greece, Guatemala, Ireland, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Philippines, Poland, Portugal, Russia, South Korea, Spain, Sweden, Turkey, United Kingdom, United States
Health Condition(s) or Problem(s) Studied

Breast Neoplasms


Results 551 - 554 of 554
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