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A Study in People With Systemic Sclerosis to Test Whether Avenciguat (BI 685509) Has an Effect on Lung...
Scleroderma, Systemic
This study is open to adults aged 18 and older or above legal age who have systemic
sclerosis. People can participate if they have a specific subtype called diffuse
cutaneous systemic sclerosis. People with another subtype called limited cutaneous
systemic sclerosis can also participate if they are... expand
This study is open to adults aged 18 and older or above legal age who have systemic sclerosis. People can participate if they have a specific subtype called diffuse cutaneous systemic sclerosis. People with another subtype called limited cutaneous systemic sclerosis can also participate if they are anti Scl-70 antibody positive. Systemic sclerosis is also called scleroderma. The purpose of this study is to find out whether a medicine called Avenciguat (BI 685509) helps people with scleroderma who have symptoms due to lung fibrosis or vascular problems. Participants are put into 2 groups by chance. One group takes Avenciguat (BI 685509) tablets 3 times a day and the other group takes placebo tablets 3 times a day. Placebo tablets look like BI 685509 tablets but do not contain any medicine. Participants take the tablets for at least 11 months. Afterwards, participants can continue to take the tablets until the last participant has completed the 11-months treatment period. This means that the time in the study and duration of treatment is different for each participant, depending on when they start the study. At the beginning of the study, participants visit the study site every 2 weeks. The time between the visits to the study site gets longer over the course of the study. After the 11-months treatment period, participants visit the study site every 3 months. During the study, participants regularly do lung function tests. The results are compared between the 2 groups to see whether the treatment works. The participants also regularly fill in questionnaires about their scleroderma symptoms. The doctors regularly check participants' skin condition and general health and take note of any unwanted effects. Type: Interventional Start Date: Nov 2022 |
Savolitinib Plus Osimertinib Versus Platinum-based Doublet Chemotherapy in Participants With Non-Small...
Carcinoma
Non-Small-Cell Lung
Clinical study to investigate the efficacy and safety of savolitinib in combination with
osimertinib versus platinum-based doublet chemotherapy in participants with EGFR mutated,
MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC who have
progressed on treatment with Osimertinib. expand
Clinical study to investigate the efficacy and safety of savolitinib in combination with osimertinib versus platinum-based doublet chemotherapy in participants with EGFR mutated, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC who have progressed on treatment with Osimertinib. Type: Interventional Start Date: Aug 2022 |
De-Escalation of Breast Radiation Trial for Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score...
Stage I Breast Cancer
This Phase III Trial evaluates whether breast conservation surgery and endocrine therapy
results in a non-inferior rate of invasive or non-invasive ipsilateral breast tumor
recurrence (IBTR) compared to breast conservation with breast radiation and endocrine
therapy. expand
This Phase III Trial evaluates whether breast conservation surgery and endocrine therapy results in a non-inferior rate of invasive or non-invasive ipsilateral breast tumor recurrence (IBTR) compared to breast conservation with breast radiation and endocrine therapy. Type: Interventional Start Date: Jun 2021 |
Type O Whole Blood and Assessment of Age During Prehospital Resuscitation Trial
Hemorrhagic Shock
Traumatic Injury
Open label, multi-center, pre-hospital randomized trial utilizing 10 level-1 trauma
centers designed to determine the efficacy and safety of low titer whole blood
resuscitation as compared to standard of care resuscitation in patients at risk of
hemorrhagic shock and to appropriately characterize... expand
Open label, multi-center, pre-hospital randomized trial utilizing 10 level-1 trauma centers designed to determine the efficacy and safety of low titer whole blood resuscitation as compared to standard of care resuscitation in patients at risk of hemorrhagic shock and to appropriately characterize the hemostatic competency of whole blood relative to its age. Type: Interventional Start Date: Apr 2022 |
Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)
Advanced Solid Tumors
Kirsten Rat Sarcoma (KRAS) pG12C Mutation
To evaluate the safety and tolerability of sotorasib administered in investigational
regimens in adult participants with KRAS p.G12C mutant advanced solid tumors. expand
To evaluate the safety and tolerability of sotorasib administered in investigational regimens in adult participants with KRAS p.G12C mutant advanced solid tumors. Type: Interventional Start Date: Dec 2019 |
Home-Based Cardiac Rehabilitation for Patients With Heart Failure
Heart Failure With Preserved Ejection Fraction
Heart Failure With Reduced Ejection Fraction
Cardiovascular Diseases
The vast majority of individuals with heart failure do not participate in center based
cardiac rehabilitation (CBCR). While steps to increase utilization of CBCR are important,
many individuals will still not participate for a variety of reasons. This pilot
randomized controlled trial is evaluating... expand
The vast majority of individuals with heart failure do not participate in center based cardiac rehabilitation (CBCR). While steps to increase utilization of CBCR are important, many individuals will still not participate for a variety of reasons. This pilot randomized controlled trial is evaluating a home-based cardiac rehabilitation (HBCR) intervention delivered using a custom app and digital tools in patients with heart failure. After a brief roll-in period, participants are randomized to one of two groups: (1) control or (2) HBCR mobile health intervention. The intervention targets key health behaviors and includes traditional cardiac rehabilitation components. The study will assess the effect of the intervention on physical activity, quality of life, clinical events, and other outcomes. Type: Interventional Start Date: Aug 2024 |
Study of GS-1427 in Participants With Moderately to Severely Active Ulcerative Colitis
Ulcerative Colitis
The goal of this study is to learn if GS-1427 is effective and safe in treating
participants with moderate to severe ulcerative colitis. The study will compare
participants in different treatment groups treated with GS-1427 with participants treated
with placebo (Part 1), and participants treated... expand
The goal of this study is to learn if GS-1427 is effective and safe in treating participants with moderate to severe ulcerative colitis. The study will compare participants in different treatment groups treated with GS-1427 with participants treated with placebo (Part 1), and participants treated with GS-1427 or ustekinumab alone with participants treated with GS-1427 in combination with ustekinumab (Part 2). The primary objectives of this study are: Part 1: To assess the efficacy of GS-1427, compared with placebo control, in achieving clinical response at Week 12 Part 2: To assess the efficacy of combination therapy with GS-1427 and ustekinumab, compared with GS-1427 and ustekinumab monotherapies, in achieving clinical response at Week 12 Type: Interventional Start Date: Mar 2024 |
Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults With Symptomatic...
Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy
This clinical trial will study the effects of aficamten (versus placebo) on the quality
of life, exercise capacity, and clinical outcomes of patients with non-obstructive
hypertrophic cardiomyopathy. expand
This clinical trial will study the effects of aficamten (versus placebo) on the quality of life, exercise capacity, and clinical outcomes of patients with non-obstructive hypertrophic cardiomyopathy. Type: Interventional Start Date: Aug 2023 |
A Study to Evaluate Long-term Safety of Ecopipam Tablets in Children, Adolescents and Adults With Tourette's...
Tourette Syndrome
The primary objective of this study is to evaluate the long-term safety and tolerability
of ecopipam tablets in children (greater than or equal to [>=] 6 and less than [<] 12
years of age), adolescents (>=12 and <18 years of age), and adults (>=18 years of age)
with Tourette's Syndrome (TS). expand
The primary objective of this study is to evaluate the long-term safety and tolerability of ecopipam tablets in children (greater than or equal to [>=] 6 and less than [<] 12 years of age), adolescents (>=12 and <18 years of age), and adults (>=18 years of age) with Tourette's Syndrome (TS). Type: Interventional Start Date: Aug 2023 |
Safety and Efficacy Study of Intracystic TARA-002 for the Treatment of Lymphatic Malformations in Participants...
Lymphatic Malformation
This is a Phase 2a/b single arm open label study to evaluate the safety, reactogenicity,
and efficacy of intracystic injection of TARA-002 in participants 6 months to less than
18 years of age for the treatment of macrocystic and mixed cystic lymphatic
malformations. The Phase 2a safety lead-in, age... expand
This is a Phase 2a/b single arm open label study to evaluate the safety, reactogenicity, and efficacy of intracystic injection of TARA-002 in participants 6 months to less than 18 years of age for the treatment of macrocystic and mixed cystic lymphatic malformations. The Phase 2a safety lead-in, age de-escalation study is designed to establish the safety of TARA-002 in older participants 6 years to less than 18 years before proceeding to younger participants 2 years to less than 6 years, then 6 months to less than 2 years. The Phase 2b is an expansion study in which enrollment of participants will be initiated after safety has been established in each cohort during the Phase 2a safety lead-in study. Each participant will receive up to 4 injections of TARA-002 spaced approximately 6 weeks apart. Type: Interventional Start Date: Oct 2023 |
A Study of Immune Checkpoint Inhibitor Combinations With Axitinib in Participants With Untreated Locally...
Renal Cell Carcinoma
This study will evaluate the efficacy, safety, and pharmacokinetics of tobemstomig (also
known as RO7247669) in combination with axitinib alone or with tiragolumab (anti-TIGIT)
and axitinib, as compared to pembrolizumab and axitinib in participants with previously
untreated, unresectable locally advanced... expand
This study will evaluate the efficacy, safety, and pharmacokinetics of tobemstomig (also known as RO7247669) in combination with axitinib alone or with tiragolumab (anti-TIGIT) and axitinib, as compared to pembrolizumab and axitinib in participants with previously untreated, unresectable locally advanced or metastatic clear-cell renal cell carcinoma (ccRCC). Type: Interventional Start Date: Apr 2023 |
DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
Venous Thromboembolism
Deep Venous Thrombosis
Post-Thrombotic Syndrome
This study is a prospective, multicenter, randomized controlled trial of an
interventional strategy using the ClotTriever System to achieve and maintain vessel
patency (ClotTriever Intervention Arm) versus conservative medical management using
anticoagulation therapy alone (Conservative Medical Management... expand
This study is a prospective, multicenter, randomized controlled trial of an interventional strategy using the ClotTriever System to achieve and maintain vessel patency (ClotTriever Intervention Arm) versus conservative medical management using anticoagulation therapy alone (Conservative Medical Management Arm) in the treatment of subjects with symptomatic unilateral iliofemoral DVT. The study will collect data on demographics, comorbidities, details from the DVT diagnosis and treatment, and clinical outcomes through the 6-month follow up visit. Type: Interventional Start Date: Jan 2023 |
Phase 3 Efficacy and Durability of Ampreloxetine for the Treatment of Symptomatic nOH in Participants...
Symptomatic Neurogenic Orthostatic Hypotension
MSA - Multiple System Atrophy
This is a Phase 3, multi-center, randomized withdrawal study to evaluate the efficacy and
durability of ampreloxetine in participants with MSA and symptomatic nOH after 20 weeks
of treatment. This study includes 4 periods: Screening, open label, randomized
withdrawal, and long-term treatment extension... expand
This is a Phase 3, multi-center, randomized withdrawal study to evaluate the efficacy and durability of ampreloxetine in participants with MSA and symptomatic nOH after 20 weeks of treatment. This study includes 4 periods: Screening, open label, randomized withdrawal, and long-term treatment extension (LTE). Type: Interventional Start Date: Jun 2023 |
Testing the Addition of Total Ablative Therapy to Usual Systemic Therapy Treatment for Limited Metastatic...
Metastatic Colorectal Adenocarcinoma
Stage IV Colorectal Cancer AJCC v8
This phase III trial compares total ablative therapy and usual systemic therapy to usual
systemic therapy alone in treating patients with colorectal cancer that has spread to up
to 4 body sites (limited metastatic). The usual approach for patients who are not
participating in a study is treatment... expand
This phase III trial compares total ablative therapy and usual systemic therapy to usual systemic therapy alone in treating patients with colorectal cancer that has spread to up to 4 body sites (limited metastatic). The usual approach for patients who are not participating in a study is treatment with intravenous (IV) (through a vein) and/or oral medications (systemic therapy) to help stop the cancer sites from getting larger and the spread of the cancer to additional body sites. Ablative means that the intention of the local treatment is to eliminate the cancer at that metastatic site. The ablative local therapy will consist of very focused, intensive radiotherapy called stereotactic ablative radiotherapy (SABR) with or without surgical resection and/or microwave ablation, which is a procedure where a needle is temporarily inserted in the tumor and heat is used to destroy the cancer cells. SABR, surgical resection, and microwave ablation have been tested for safety, but it is not scientifically proven that the addition of these treatments are beneficial for your stage of cancer. The addition of ablative local therapy to all known metastatic sites to the usual approach of systemic therapy could shrink or remove the tumor(s) or prevent the tumor(s) from returning. Type: Interventional Start Date: Jan 2023 |
A Study of Dato-DXd With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With...
Breast Cancer
This is a Phase III, randomized, open-label, 3-arm, multicenter, international study
assessing the efficacy and safety of Dato-DXd with or without durvalumab compared with
ICT in participants with stage I to III TNBC with residual invasive disease in the breast
and/or axillary lymph nodes at surgical... expand
This is a Phase III, randomized, open-label, 3-arm, multicenter, international study assessing the efficacy and safety of Dato-DXd with or without durvalumab compared with ICT in participants with stage I to III TNBC with residual invasive disease in the breast and/or axillary lymph nodes at surgical resection following neoadjuvant systemic therapy Type: Interventional Start Date: Nov 2022 |
A Trial Comparing Unrelated Donor BMT With IST for Pediatric and Young Adult Patients With Severe Aplastic...
Severe Aplastic Anemia
Severe Aplastic Anemia (SAA) is a rare condition in which the body stops producing enough
new blood cells. SAA can be cured with immune suppressive therapy or a bone marrow
transplant. Regular treatment for patients with aplastic anemia who have a matched
sibling (brother or sister), or family donor... expand
Severe Aplastic Anemia (SAA) is a rare condition in which the body stops producing enough new blood cells. SAA can be cured with immune suppressive therapy or a bone marrow transplant. Regular treatment for patients with aplastic anemia who have a matched sibling (brother or sister), or family donor is a bone marrow transplant. Patients without a matched family donor normally are treated with immune suppressive therapy (IST). Match unrelated donor (URD) bone marrow transplant (BMT) is used as a secondary treatment in patients who did not get better with IST, had their disease come back, or a new worse disease replaced it (like leukemia). This trial will compare time from randomization to failure of treatment or death from any cause of IST versus URD BMT when used as initial therapy to treat SAA. The trial will also assess whether health-related quality of life and early markers of fertility differ between those randomized to URD BMT or IST, as well as assess the presence of marrow failure-related genes and presence of gene mutations associated with MDS or leukemia and the change in gene signatures after treatment in both study arms. This study treatment does not include any investigational drugs. The medicines and procedures in this study are standard for treatment of SAA. Type: Interventional Start Date: Jan 2023 |
A Study of Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of KAN-101 in Celiac Disease...
Celiac Disease
This study is to evaluate the Pharmacodynamic (PD), safety, tolerability, Pharmacokinetic
(PK), and plasma biomarker response of KAN-101 in participants with Celiac Disease (CeD). expand
This study is to evaluate the Pharmacodynamic (PD), safety, tolerability, Pharmacokinetic (PK), and plasma biomarker response of KAN-101 in participants with Celiac Disease (CeD). Type: Interventional Start Date: Nov 2022 |
A Study to Assess the Efficacy and Safety of BIIB059 (Litifilimab) in Participants With Active Subacute...
Subacute Cutaneous Lupus Erythematosus
Chronic Cutaneous Lupus Erythematosus
The primary objectives of the study are to evaluate the efficacy of BIIB059 (litifilimab)
compared with placebo in reducing skin disease activity measured by the Cutaneous Lupus
Activity of Physician's Global Assessment-Revised (CLA-IGA-R) score [Parts A and B (US)]
and the Cutaneous Lupus Erythematosus... expand
The primary objectives of the study are to evaluate the efficacy of BIIB059 (litifilimab) compared with placebo in reducing skin disease activity measured by the Cutaneous Lupus Activity of Physician's Global Assessment-Revised (CLA-IGA-R) score [Parts A and B (US)] and the Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) score [Part B (ROW)] in participants with active SCLE and/or CCLE with or without systemic manifestations and refractory and/or intolerant to antimalarials. The secondary objectives of the study are to evaluate the efficacy of BIIB059 in reducing SCLE and/or CCLE disease activity by CLA-IGA-R, CLASI-A; to evaluate additional efficacy parameters of BIIB059 in reducing SCLE and/or CCLE disease activity; safety; tolerability; and immunogenicity of BIIB059 [Parts A and B]. Type: Interventional Start Date: Sep 2022 |
A Study of ASP3082 in Adults With Previously Treated Solid Tumors
Solid Tumor
Genes contain genetic code which tell the body which proteins to make. Many types of
cancer are caused by changes, or mutations, in a gene called KRAS. Researchers are
looking for ways to stop the actions of abnormal proteins made from the mutated KRAS
gene. The so-called G12D mutation in the KRAS... expand
Genes contain genetic code which tell the body which proteins to make. Many types of cancer are caused by changes, or mutations, in a gene called KRAS. Researchers are looking for ways to stop the actions of abnormal proteins made from the mutated KRAS gene. The so-called G12D mutation in the KRAS gene is common in people with some solid tumors. ASP3082 is a potential new treatment for solid tumors in people who have the G12D mutation in their KRAS gene. Before ASP3082 is available as a treatment, the researchers need to understand how it is processed by and acts upon the body. This information will help find a suitable dose and to check for potential medical problems from the treatment. People in this study will be adults with locally advanced, unresectable or metastatic solid tumors with the G12D mutation in their KRAS gene. Locally advanced means the cancer has spread to nearby tissue. Unresectable means the cancer cannot be removed by surgery. Metastatic means the cancer has spread to other parts of the body. They may have been previously treated with standard therapies. The main aims of the study are: to check the safety of ASP3082 by itself and together with cetuximab or chemotherapy, and how well it is tolerated, and to find a suitable dose of ASP3082 by itself and together with cetuximab or chemotherapy. This is an open-label study. This means that people in this study and clinic staff will know that they will receive ASP3082. This study will be in 2 parts. In Part 1, different small groups of people will receive lower to higher doses of ASP3082, by itself, or together with cetuximab. Any medical problems will be recorded at each dose. This is done to find suitable doses of ASP3082, by itself or together with cetuximab to use in Part 2 of the study. The first group will receive the lowest dose of ASP3082. A medical expert panel will check the results from this group and decide if the next group can receive a higher dose of ASP3082. The panel will do this for each group until all groups have received ASP3082 (by itself or together with cetuximab) or until suitable doses have been selected for Part 2. In Part 2, other different small groups of people will receive ASP3082 by itself or together with cetuximab or chemotherapy, with the most suitable doses worked out from Part 1. This will help find a more accurate dose of ASP3082 to use in future studies. ASP3082 (cetuximab or chemotherapy if used), will be given through a vein. This is called an infusion. Each treatment cycle is 21 or 28 days long. People will continue treatment until: they have medical problems from the treatment they can't tolerate; their cancer gets worse; they start other cancer treatment; or they ask to stop treatment. At some visits, other checks will include a medical examination, echocardiogram (ECHO) or multigated acquisition (MUGA) scan, blood and urine tests and vital signs. Vital signs include temperature, pulse, breathing rate, and blood pressure. (Blood oxygen levels will also be checked for people treated with ASP3082 together with cetuximab or chemotherapy.) Tumor samples will be taken during certain visits during treatment and when treatment has finished. People will visit the clinic on certain days during their treatment, with extra visits during the first 2 cycles of treatment. The study doctors will check for any medical problems from ASP3082 by itself or together with cetuximab or chemotherapy. At some visits, other checks will include a medical examination, echocardiogram (ECHO) or multigated acquisition (MUGA) scan, blood and urine tests and vital signs. Vital signs include temperature, pulse, breathing rate, and blood pressure. (Blood oxygen levels will also be checked for people treated with ASP3082 together with cetuximab or chemotherapy.) Tumor samples will be taken during certain visits during treatment and when treatment has finished. People will visit the clinic within 7 days after stopping treatment. The study doctors will check for any medical problems from ASP3082 by itself or together with cetuximab or chemotherapy. Other checks will include a medical examination, echocardiogram (ECHO) or multigated acquisition (MUGA) scan, urine and blood tests and vital signs. After this, people will continue to visit the clinic every 9 weeks to check the condition of their cancer. They will do this until 45 weeks after treatment stopped, or if their cancer is worse, they start other cancer treatment, or they ask to stop treatment. Also, people may visit the clinic at 30 days and 90 days after stopping treatment. At the 30-day visit, the study doctors will check for any medical problems from ASP3082 by itself or together with cetuximab or chemotherapy. People will have their vital signs checked and have some blood tests. At the 90-day visit, the study doctors will check for any medical problems from ASP3082 by itself or together with cetuximab or chemotherapy and people will have their vital signs checked. Type: Interventional Start Date: Jun 2022 |
A Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants With...
Advanced or Metastatic Colorectal Cancer
The purpose of this study is to assess the anti-tumor activity of amivantamab as a
monotherapy (Cohorts A, B, and C), to characterize the safety of amivantamab when added
to standard-of care (SoC) chemotherapy in participants with metastatic colorectal cancer
(mCRC) (Ph2 cohorts), and to assess the... expand
The purpose of this study is to assess the anti-tumor activity of amivantamab as a monotherapy (Cohorts A, B, and C), to characterize the safety of amivantamab when added to standard-of care (SoC) chemotherapy in participants with metastatic colorectal cancer (mCRC) (Ph2 cohorts), and to assess the recommended phase 2 combination dose (RP2CD) of amivantamab when added to SoC chemotherapy (Ph1b cohorts). Type: Interventional Start Date: Jul 2022 |
Vincristine Pharmacokinetics in Infants
Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
This pilot trial compares drug exposure levels using a new method for dosing vincristine
in infants and young children compared to the standard dosing method based on body
surface area (BSA) in older children. Vincristine is an anticancer drug used to a variety
of childhood cancers. The doses anticancer... expand
This pilot trial compares drug exposure levels using a new method for dosing vincristine in infants and young children compared to the standard dosing method based on body surface area (BSA) in older children. Vincristine is an anticancer drug used to a variety of childhood cancers. The doses anticancer drugs in children must be adjusted based on the size of the child because children vary significantly in size (height, weight, and BSA) and ability to metabolize drugs from infancy to adolescence. The dose of most anticancer drugs is adjusted to BSA, which is calculated from a patient's weight and height. However, infants and young children have more severe side effects if the BSA is used to calculate their dose, so new dosing models have to be made to safely give anticancer drugs to the youngest patients. This new method uses a BSA-banded approach to determine the dose. Collecting blood samples before and after a dose of the drug will help researchers determine whether this new vincristine dosing method results in equivalent drug levels in the blood over time in infants and young children compared to older children. Type: Observational Start Date: Nov 2022 |
Tiragolumab and Atezolizumab for the Treatment of Relapsed or Refractory SMARCB1 or SMARCA4 Deficient...
Atypical Teratoid/Rhabdoid Tumor
Epithelioid Sarcoma
Kidney Medullary Carcinoma
Malignant Solid Neoplasm
Poorly Differentiated Chordoma
This phase I/II trial studies how well tiragolumab and atezolizumab works when given to
children and adults with SMARCB1 or SMARCA4 deficient tumors that have either come back
(relapsed) or do not respond to therapy (refractory). SMARCB1 or SMARCA4 deficiency means
that tumor cells are missing the... expand
This phase I/II trial studies how well tiragolumab and atezolizumab works when given to children and adults with SMARCB1 or SMARCA4 deficient tumors that have either come back (relapsed) or do not respond to therapy (refractory). SMARCB1 or SMARCA4 deficiency means that tumor cells are missing the SMARCB1 and SMARCA4 genes, seen with some aggressive cancers that are typically hard to treat. Immunotherapy with monoclonal antibodies, such as tiragolumab and atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Type: Interventional Start Date: Nov 2022 |
(Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal...
Advanced Gastrointestinal Stromal Tumors
Metastatic Cancer
This is a Phase 3, open-label, international, multicenter study of CGT9486 in combination
with sunitinib. This is a multi-part study that will enroll approximately 426 patients.
Part 1 consists of two evaluations: 1) confirming the dose of an updated formulation of
CGT9486 to be used in subsequent... expand
This is a Phase 3, open-label, international, multicenter study of CGT9486 in combination with sunitinib. This is a multi-part study that will enroll approximately 426 patients. Part 1 consists of two evaluations: 1) confirming the dose of an updated formulation of CGT9486 to be used in subsequent parts in approximately 20 patients who have received at least one prior line of therapy for GIST and 2) evaluating for drug-drug interactions between CGT9486 and sunitinib in approximately 18 patients who have received at least two prior tyrosine kinase inhibitors (TKIs) for GISTs. The second part of the study will enroll approximately 388 patients who are intolerant to, or who failed prior treatment with imatinib only and will compare the efficacy of CGT9486 plus sunitinib to sunitinib alone with patients being randomized in a 1:1 manner. Type: Interventional Start Date: Apr 2022 |
A Research Study on How Well Concizumab Works for You if You Have Haemophilia A or B With or Without...
Haemophilia A and B With and Without Inhibitors
This study will test how well a new medicine called concizumab works for participants who
have haemophilia A or B with or without inhibitors. The purpose is to show that
concizumab can prevent bleeds and is safe to use.
Participants will have to inject the study medicine every day under the skin... expand
This study will test how well a new medicine called concizumab works for participants who have haemophilia A or B with or without inhibitors. The purpose is to show that concizumab can prevent bleeds and is safe to use. Participants will have to inject the study medicine every day under the skin with a pen-injector. The study will last for at least 2 years and up to about 4 years. The length of time the participant will be in the study depends on if the study medicine will be available for purchase in their country. Type: Interventional Start Date: Mar 2022 |
Efficacy of the COronary SInus Reducer in Patients With Refractory Angina II
Refractory Angina
To demonstrate the safety and effectiveness of the Reducer system for treatment of
patients with refractory angina pectoris treated with maximally tolerated
guideline-directed medical therapy who demonstrate objective evidence of reversible
myocardial ischemia in the distribution of the left coronary... expand
To demonstrate the safety and effectiveness of the Reducer system for treatment of patients with refractory angina pectoris treated with maximally tolerated guideline-directed medical therapy who demonstrate objective evidence of reversible myocardial ischemia in the distribution of the left coronary artery and who are deemed unsuitable for revascularization. A non-randomized single-arm will further assess the safety and effectiveness of the Neovasc Reducer System in selected subjects with reversible myocardial ischemia in the distribution of the right coronary artery and who are deemed unsuitable for revascularization, subjects with reversible myocardial ischemia without documented obstructive coronary disease and subjects who cannot complete an exercise tolerance test due to an above-the-ankle amputation. Type: Interventional Start Date: Jan 2022 |
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