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Study Of BIIB092 In Participants With Progressive Supranuclear Palsy

Scottsdale/Phoenix, AZ
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Study Of BIIB092 In Participants With Progressive Supranuclear Palsy
- 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.
About this study

The Primary objective of the study is to evaluate the efficacy of BIIB092, compared to placebo, as measured by a change from baseline in the PSP Rating Scale (PSPRS) at Week 52 and to assess the safety and tolerability of BIIB092, relative to placebo, by measuring the frequency of deaths, SAEs, AEs leading to discontinuation, and Grade 3 & 4 laboratory abnormalities. The Secondary objective of the study is to evaluate the efficacy of BIIB092, compared to placebo, as measured by a change in baseline in the Movement Disorder Society (MDS)-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II at Week 52, to evaluate the efficacy of BIIB092, compared to placebo, as measured by the Clinical Global Impression of Change (CGI-C) at Week 52, to evaluate the efficacy of BIIB092, compared to placebo, as measured by a change in baseline in the Repeatable Battery for the Assessment of Neuropsychological Disease Severity (RBANS) at Week 52 and to assess the impact of BIIB092 on quality of life, relative to placebo, as measured by change from baseline on the Progressive Supranuclear Palsy Quality of Life scale (PSP-QoL) at Week 52.

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

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Site IRB:
17-000532

NCT ID:
NCT03068468

Sponsor Protocol Number:
CN002012

Folate Receptor Alpha Peptide Vaccine With GM-CSF Versus GM-CSF Alone In Patients With Platinum Sensitive Ovarian Cancer

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

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Folate Receptor Alpha Peptide Vaccine With GM-CSF Versus GM-CSF Alone In Patients With Platinum Sensitive Ovarian 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 is a double-blind, randomized, Phase II trial. Patients with advanced ovarian cancer that has not progressed following completion of standard-of-care chemotherapy are eligible to participate. Patients will be randomized to either the vaccine regimen with GM-CSF adjuvant or GM-CSF adjuvant alone as a control group. Treatment will be administered as a consolidation therapy beginning within one year of the last administration of platinum.

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

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Site IRB:
17-003933
NCT ID:
NCT02978222
Sponsor Protocol Number:
FRV-004

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
Jacksonville, FL	Closed for enrollment	View complete study & contact information

Molecularly Targeted Therapy In Treating Patients With BRAF Wild-type Melanoma That Is Metastatic

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

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Molecularly Targeted Therapy In Treating Patients With BRAF Wild-type Melanoma That Is Metastatic

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 molecularly targeted therapy works in treating patients with melanoma that has spread to other parts of the body. Patients must have received or do not qualify for prior immunotherapy. Targeted therapy is a type of treatment that uses drugs or other substances to identify and attack specific types of cancer cells with less harm to normal cells. Molecularly targeted therapy works by treating patients with substances that kill cancer cells by targeting key molecules involved in cancer cell growth.

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:
14-004365
NCT ID:
NCT02094872
Sponsor Protocol Number:
HIC#1408014446

Placebo Controlled Study Of VS-6063 In Subjects With Malignant Pleural Mesothelioma

Rochester, MN
- See Details
Placebo Controlled Study Of VS-6063 In Subjects With Malignant Pleural Mesothelioma
- 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 study is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study of defactinib (VS-6063) in subjects with malignant pleural mesothelioma (MPM) who have not progressed (confirmed partial response or stable disease) following ≥ 4 cycles of treatment with pemetrexed/cisplatin or pemetrexed/carboplatin. Prior to entry and randomization to the study, each subject must have tumor Merlin status(high or low) established by immunohistochemistry performed at a central laboratory. Subjects will be randomized in a 1:1 ratio to receive oral VS-6063 400 mg twice per day, or matched placebo. Randomization will be stratified by tumor Merlin status (high versus low). Progression will be assessed both locally and by central review using the Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1. Subjects will continue to receive treatment until disease progression or other discontinuation criteria are met. Following documentation of nonfatal disease progression, all subjects will be followed for overall survival by telephone contact every 2 months until end of life or the close of the study.

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:
13-009668

NCT ID:
NCT01870609

Sponsor Protocol Number:
VS-6063-202

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

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Search Results 5851-5860 of 11918

Study Of BIIB092 In Participants With Progressive Supranuclear Palsy

Folate Receptor Alpha Peptide Vaccine With GM-CSF Versus GM-CSF Alone In Patients With Platinum Sensitive Ovarian Cancer

A Dose-Ranging Study To Evaluate The Effectiveness And Safety Of Topical Rapamycin Cream For Facial Angiofibroma Associated With Tuberous Sclerosis Complex

A Study To Evaluate AVID200 In Myelofibrosis Patients

A Study To Evaluate The Effectiveness And Safety Of PANZYGA In Pediatric Patients With Chronic Immune Thrombocytopenia (ITP)

A Study To Evaluate Abemaciclib To Treat Advanced Bone And Soft Tissue Sarcoma Identified As Having CDK Pathway Alteration

Ruxolitinib Prior To Transplant In Patients With Myelofibrosis

Transoral Surgery Followed By Low-Dose Or Standard-Dose Radiation Therapy With Or Without Chemotherapy In Treating Patients With HPV Positive Stage III-IVA Oropharyngeal Cancer

Molecularly Targeted Therapy In Treating Patients With BRAF Wild-type Melanoma That Is Metastatic

Placebo Controlled Study Of VS-6063 In Subjects With Malignant Pleural Mesothelioma

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