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Efficacy And Safety Study Of Mepolizumab In Subjects With Severe Hypereosinophilic Syndrome (HES)

Rochester, MN
- See Details
Efficacy And Safety Study Of Mepolizumab In Subjects With Severe Hypereosinophilic Syndrome (HES)
- Study type:
  Interventional
  Describes the nature of a clinical study. Types include:
  
  Observational study — observes people and measures outcomes without affecting results.
  
  Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
  
  Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Study phase:
  3
  During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
About this study

Mepolizumab is a humanized monoclonal antibody. In conditions where eosinophilia is considered to play an important part in the pathology, including eosinophilic asthma, HES, and eosinophilic granulomatosis with polyangiitis, a consistent reduction in blood eosinophil counts is observed in association with mepolizumab administration, with concomitant clinical improvement. This is a 32-week treatment period, randomized, double-blind, placebo-controlled, parallel group, multicentre study of mepolizumab in adolescent and adult subjects with severe HES receiving standard of care (SoC) therapy. This study will demonstrate the efficacy of mepolizumab compared with placebo based on maintenance of control of HES symptoms during the treatment period. The study will comprise of a screening period of up to approximately 4 weeks followed by a 32-Week study treatment period (subjects will be randomized 1:1 to placebo or mepolizumab) and up to 8-week additional follow-up period (12 weeks after the last dose of study treatment).

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, MN

Closed for enrollment
View complete study & contact information

Print study details
Site IRB:
17-000292

NCT ID:
NCT02836496

Sponsor Protocol Number:
200622

Mayo Clinic Location	Status	Contact
Rochester, MN	Closed for enrollment	View complete study & contact information

A Study To Evaluate TVB-2640 And Trastuzumab Plus Paclitaxel Or Endocrine Therapy For Treating Patients With HER2 Positive Advanced Breast Cancer

Scottsdale/Phoenix, AZ, Jacksonville, FL, Rochester, MN

See Details

A Study To Evaluate TVB-2640 And Trastuzumab Plus Paclitaxel Or Endocrine Therapy For Treating Patients With HER2 Positive Advanced Breast Cancer

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
2
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

This phase II trial studies how well FASN inhibitor TVB-2640 and trastuzumab plus either paclitaxel or endocrine therapy with an aromatase inhibitor work in treating patients with HER2 positive breast cancer that has spread to other places in the body. FASN inhibitor TVB-2640 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and trastuzumab, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Endcocrine therapy helps reduce the hormones that feed tumor cells. Giving FASN inhibitor TVB-2640 and trastuzumab with either paclitaxel or endocrine therapy may work better in treating patients with HER2 positive breast cancer.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Scottsdale/Phoenix, AZ	Closed for enrollment	View complete study & contact information
Jacksonville, FL	Closed for enrollment
Rochester, MN	Closed for enrollment

Print study details

Site IRB:
16-010066
NCT ID:
NCT03179904
Sponsor Protocol Number:
MC1633

Mayo Clinic Location	Status	Contact
Rochester, MN	Closed for enrollment	View complete study & contact information

Mayo Clinic Location	Status	Contact
Rochester, MN	Closed-enrolling by invitation What is this? (?)	View complete study & contact information

Mayo Clinic Location	Status	Contact
Rochester, MN	Closed for enrollment	View complete study & contact information

Mayo Clinic Location	Status	Contact
Rochester, MN	Closed for enrollment	View complete study & contact information

Mayo Clinic Location	Status	Contact
Scottsdale/Phoenix, AZ	Closed-enrolling by invitation What is this? (?)	View complete study & contact information

Mayo Clinic Location	Status	Contact
Scottsdale/Phoenix, AZ	Closed-enrolling by invitation What is this? (?)	View complete study & contact information

Mayo Clinic Location	Status	Contact
Rochester, MN	Closed for enrollment	View complete study & contact information

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Search Results 1541-1550 of 11888

Efficacy And Safety Study Of Mepolizumab In Subjects With Severe Hypereosinophilic Syndrome (HES)

A Study To Evaluate TVB-2640 And Trastuzumab Plus Paclitaxel Or Endocrine Therapy For Treating Patients With HER2 Positive Advanced Breast Cancer

Cardiac Resynchronization Therapy In Previously Untreatable And High Risk Upgrade Patients

A Study Of Clinical Outcomes Data And Imaging For Patients Receiving Cartiform For Articular Cartilage Defects As Treatment

Transcranial Direct Current Stimulation (TDCS) In Children And Adolescents With Epilepsy And Depression

Multi-center ESG Randomized Interventional Trial (MERIT-Trial)

Testing An Active Form Of Tamoxifen (4-hydroxytamoxifen) Delivered Through The Breast Skin To Control Ductal Carcinoma In Situ (DCIS) Of The Breast

A Study Of LY2951742 (Galcanezumab) In Participants With Cluster Headache

Laryngeal Allograft Transplantation

A Study Of Efficacy And Safety Of Mongersen (GED-0301) For The Treatment Of Adult And Adolescent Subjects With Active Crohn's Disease

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