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Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory...
Advanced Malignant Solid Neoplasm
Ann Arbor Stage III Non-Hodgkin Lymphoma
Ann Arbor Stage IV Non-Hodgkin Lymphoma
Histiocytic Sarcoma
Juvenile Xanthogranuloma
This Pediatric MATCH screening and multi-sub-study phase II trial studies how well
treatment that is directed by genetic testing works in pediatric patients with solid
tumors, non-Hodgkin lymphomas, or histiocytic disorders that have progressed following at
least one line of standard systemic therapy... expand
This Pediatric MATCH screening and multi-sub-study phase II trial studies how well treatment that is directed by genetic testing works in pediatric patients with solid tumors, non-Hodgkin lymphomas, or histiocytic disorders that have progressed following at least one line of standard systemic therapy and/or for which no standard treatment exists that has been shown to prolong survival. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic changes or abnormalities (mutations) may benefit more from treatment which targets their tumor's particular genetic mutation, and may help doctors plan better treatment for patients with solid tumors or non-Hodgkin lymphomas. Type: Interventional Start Date: Jul 2017 |
Active Surveillance, Bleomycin, Etoposide, Carboplatin or Cisplatin in Treating Pediatric and Adult Patients...
Childhood Extracranial Germ Cell Tumor
Extragonadal Embryonal Carcinoma
Germ Cell Tumor
Malignant Germ Cell Tumor
Malignant Ovarian Teratoma
This phase III trial studies how well active surveillance help doctors to monitor
subjects with low risk germ cell tumors for recurrence after their tumor is removed. When
the germ cell tumor has spread outside of the organ in which it developed, it is
considered metastatic. Drugs used in chemotherapy,... expand
This phase III trial studies how well active surveillance help doctors to monitor subjects with low risk germ cell tumors for recurrence after their tumor is removed. When the germ cell tumor has spread outside of the organ in which it developed, it is considered metastatic. Drugs used in chemotherapy, such as bleomycin, carboplatin, etoposide, and cisplatin, 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. The trial studies whether carboplatin or cisplatin is the preferred chemotherapy to use in treating metastatic standard risk germ cell tumors. Type: Interventional Start Date: May 2017 |
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 |
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 |
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 |
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 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 |
(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 |
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 |
Comparison of Chemotherapy Before and After Surgery Versus After Surgery Alone for the Treatment of Gallbladder...
Stage II Gallbladder Cancer AJCC v8
Stage IIA Gallbladder Cancer AJCC v8
Stage IIB Gallbladder Cancer AJCC v8
Stage III Gallbladder Cancer AJCC v8
Stage IIIA Gallbladder Cancer AJCC v8
This phase II/III trial compares the effect of adding chemotherapy before and after
surgery versus after surgery alone (usual treatment) in treating patients with stage
II-III gallbladder cancer. Chemotherapy drugs, such as gemcitabine and cisplatin, work in
different ways to stop the growth of tumor... expand
This phase II/III trial compares the effect of adding chemotherapy before and after surgery versus after surgery alone (usual treatment) in treating patients with stage II-III gallbladder cancer. Chemotherapy drugs, such as gemcitabine and cisplatin, 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. Giving chemotherapy before surgery may make the tumor smaller; therefore, may reduce the extent of surgery. Additionally, it may make it easier for the surgeon to distinguish between normal and cancerous tissue. Giving chemotherapy after surgery may kill any remaining tumor cells. This study will determine whether giving chemotherapy before surgery increases the length of time before the cancer may return and whether it will increase a patient's life span compared to the usual approach. Type: Interventional Start Date: Feb 2021 |
Abatacept for the Treatment of Giant Cell Arteritis
Giant Cell Arteritis
This randomized, double-blind, placebo-controlled trial will seek to determine the
efficacy of abatacept in GCA. To examine this objective, 62 eligible patients who have
newly diagnosed or relapsing GCA within 8 weeks prior to screening will be randomized at
a 1:1 ratio to receive subcutaneous abatacept... expand
This randomized, double-blind, placebo-controlled trial will seek to determine the efficacy of abatacept in GCA. To examine this objective, 62 eligible patients who have newly diagnosed or relapsing GCA within 8 weeks prior to screening will be randomized at a 1:1 ratio to receive subcutaneous abatacept 125mg/week or placebo. Patients who achieve remission will remain on their blinded assignment for 12 months at which time abatacept/placebo will be stopped. Patients who do not achieve remission by Month 3, who experience a relapse within the first 12 months will have the option of receiving open-label abatacept for a maximum of 12 months. Type: Interventional Start Date: Mar 2021 |
Study to Learn More About the Safety and Effectiveness of the Drug VITRAKVI During Routine Use in Patients...
Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion
In this observational study researcher want to learn more about the effectiveness of drug
VITRAKVI (generic name: larotrectinib) and how well the drug is tolerated during routine
use in patients with TRK fusion cancer which is locally advanced or spread from the place
where it started to other places... expand
In this observational study researcher want to learn more about the effectiveness of drug VITRAKVI (generic name: larotrectinib) and how well the drug is tolerated during routine use in patients with TRK fusion cancer which is locally advanced or spread from the place where it started to other places in the body. TRK fusion cancer is a term used to describe a variety of common and rare cancers that are caused by a change to the NTRK (Neurotrophic Tyrosine Kinase) gene called a fusion. During this fusion, an NTRK gene joins together, or fuses, with a different gene. This joining results in the activation of certain proteins (TRK fusion proteins), which can cause cancer cells to multiply and form a tumor. VITRAKVI is an approved drug that blocks the action of the NTRK gene fusion. This study will enroll adult and paediatric patients suffering from a solid tumor with NTRK gene fusion for whom the decision to treat their disease with VITRAKVI has been made by their treating physicians. During the study, patients' medical information such as treatment information with VITRAKVI, other medication or treatments, changes in disease status and other health signs and symptoms will be collected within the normal medical care by the treating doctor. Participants will be observed over a period from 24 to 60 months. Type: Observational Start Date: Apr 2020 |
Cholinergic Health After Menopause (CHAMP)
Postmenopausal Symptoms
Aging
Alzheimer Disease
Women are at increased risk for Alzheimer's disease (AD). Notably at menopause, some
women experience a change in cognition. However, not all women experience negative
effects of menopause on cognition. The cognitive changes that occur at menopause have not
yet been connected to late life risk for... expand
Women are at increased risk for Alzheimer's disease (AD). Notably at menopause, some women experience a change in cognition. However, not all women experience negative effects of menopause on cognition. The cognitive changes that occur at menopause have not yet been connected to late life risk for pathological aging including AD. Thus, understanding the neurobiological factors related to individual differences in cognition at menopause is critical for understanding normal cognitive aging and for determining risk for pathological aging. The challenge in understanding the role of estrogen loss on the risk for AD is the long lag time between the hormonal changes at menopause and the clinical manifestations of AD. Thus, identifying how the hormone changes after menopause are related to AD risk will alter the risk calculus for postmenopausal women in the future. The novel study proposed here will examine an established AD-related neurotransmitter-based mechanism that may also underlie cognitive changes after menopause. The investigators propose that the change in the hormonal milieu at menopause interacts with the cholinergic system and other brain pathologies to influence a woman's risk for cognitive decline. Preclinical studies have shown that estrogen is necessary for normal cholinergic functioning and its withdrawal leads to cholinergic dysfunction and cognitive impairment. It is important to determine whether menopause-related cognitive changes correlate with both cholinergic functional integrity and established AD biomarkers that portend increased risk for late-life cognitive impairment or dementia. This study will examine brain functioning following cholinergic blockade to separate individuals into those who are able to compensate for the hormone change after menopause and those who are not. The investigators hypothesize women with poor compensation have increased sensitivity to cholinergic blockade by showing poor performance on a cognitive task, altered brain activation, and decreased basal forebrain cholinergic system (BFCS) volume. These cholinergic markers will be related to menopausal factors associated with poor cognition and biomarkers of AD. Specific Aim 1 is to examine cholinergic functional "integrity" by measuring working memory performance, functional brain activation, and BFCS structure in postmenopausal women. Specific Aim 2 will examine whether individual differences in menopause-relevant symptoms and known AD biomarkers are related to cognition and brain activation after anticholinergic challenge. The public health significance of this study is that it will identify individual difference factors that are associated with cognitive performance changes after menopause and their relationship to structural, functional, and biomarker evidence of risk for later life cognitive dysfunction. Knowledge of these factors will serve to advance personalized future risk-mitigation strategies for women including hormonal, medication, cognitive remediation, etc. that will be the subject of further research. Type: Interventional Start Date: Mar 2020 |
Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial
Tricuspid Regurgitation
Tricuspid Valve Insufficiency
Tricuspid Valve Disease
To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Repair
System in patients with symptomatic severe tricuspid regurgitation who have been
determined to be at an intermediate or greater estimated risk of mortality with tricuspid
valve surgery by the cardiac surgeon with... expand
To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Repair System in patients with symptomatic severe tricuspid regurgitation who have been determined to be at an intermediate or greater estimated risk of mortality with tricuspid valve surgery by the cardiac surgeon with concurrence by the local Heart Team Type: Interventional Start Date: Dec 2019 |
Chest Drain Regular Flushing in Complicated Parapneumonic Effusions and Empyemas
Empyema, Pleural
Pleural Infection
Infections of the pleural space are common, and patients require antibiotics and chest
drain placement to evacuate the chest from the infected fluid. Chest drains can get
blocked by the drainage fluid and material. For this reason, it is thought that flushing
the chest drain with saline solution,... expand
Infections of the pleural space are common, and patients require antibiotics and chest drain placement to evacuate the chest from the infected fluid. Chest drains can get blocked by the drainage fluid and material. For this reason, it is thought that flushing the chest drain with saline solution, can help maintain the patency of the tube. This proposed study will evaluate the impact of regular chest drain flushing on the length of time to chest tube removal and total hospitalization as well as improvement in chest imaging and the need for additional interventions on the infected space. Type: Interventional Start Date: Jun 2024 |
The ACES Study for Aseptic Pleural Effusion
Pleural Effusion
The study will enroll recurrent aseptic pleural effusion patients who are designated by
their physician as needing treatment to control the fluid. Baseline assessment will
include a history and physical, chest imaging and quality of life questionnaires.
After ACES implantation, patients will remain... expand
The study will enroll recurrent aseptic pleural effusion patients who are designated by their physician as needing treatment to control the fluid. Baseline assessment will include a history and physical, chest imaging and quality of life questionnaires. After ACES implantation, patients will remain under hospital care for general observation as per standard-of-care before being discharged home with access to electronic diaries for tracking pain and dyspnea. Type: Interventional Start Date: May 2024 |
A Pivotal Study to Evaluate the Efficacy of Lorundrostat in Subjects With Uncontrolled Hypertension on...
Hypertension
a Phase 2 trial to evaluate the blood pressure-lowering effect of lorundrostat (an
aldosterone synthase inhibitor), administered on a background of a standardized
anti-hypertensive (AHT) medication regimen, in subjects with uncontrolled and/or
treatment-resistant hypertension. expand
a Phase 2 trial to evaluate the blood pressure-lowering effect of lorundrostat (an aldosterone synthase inhibitor), administered on a background of a standardized anti-hypertensive (AHT) medication regimen, in subjects with uncontrolled and/or treatment-resistant hypertension. Type: Interventional Start Date: Mar 2023 |
Evaluation of Revumenib in Participants With Colorectal Cancer and Other Solid Tumors
Colorectal Cancer
Solid Tumors
This study will evaluate the safety, tolerability, pharmacokinetics (PK), and anti-tumor
activity of revumenib in participants with colorectal cancer (CRC) or other solid tumors
who have failed at least 1 prior line of therapy. expand
This study will evaluate the safety, tolerability, pharmacokinetics (PK), and anti-tumor activity of revumenib in participants with colorectal cancer (CRC) or other solid tumors who have failed at least 1 prior line of therapy. Type: Interventional Start Date: Apr 2023 |
A Phase 1 Study of AB521 Monotherapy and Combination Therapies in Renal Cell Carcinoma and Other Solid...
Clear Cell Renal Cell Carcinoma
Solid Tumors
The purpose of this study is to evaluate the safety and tolerability of:
- casdatifan when taken alone in participants with advanced solid tumor malignancies
and clear cell renal cell carcinoma (ccRCC) during the dose escalation stage; and
- casdatifan monotherapy and casdatifan in... expand
The purpose of this study is to evaluate the safety and tolerability of: - casdatifan when taken alone in participants with advanced solid tumor malignancies and clear cell renal cell carcinoma (ccRCC) during the dose escalation stage; and - casdatifan monotherapy and casdatifan in combination with cabozantinib in participants with ccRCC in the dose expansion stage Type: Interventional Start Date: Oct 2022 |
A Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants ≥2 Years to <12 Years...
Chronic Spontaneous Urticaria
This is a multicenter, single-arm, 24-week treatment, Phase 3 study. The purpose of this
study is to investigate the PK and safety of dupilumab in children diagnosed with CSU who
remain symptomatic despite the use of H1-antihistamine treatment. Study details include:
Screening: 2 to 4 weeks; The treatment... expand
This is a multicenter, single-arm, 24-week treatment, Phase 3 study. The purpose of this study is to investigate the PK and safety of dupilumab in children diagnosed with CSU who remain symptomatic despite the use of H1-antihistamine treatment. Study details include: Screening: 2 to 4 weeks; The treatment duration will be 24 weeks; Follow-up period: 12 weeks; The study duration will be 38 to 40 weeks (including screening and follow-up); The number of study visits will be 6. Type: Interventional Start Date: Aug 2022 |
ABTECT-2 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -2
Ulcerative Colitis
This is a multicenter, randomized, placebo controlled study to evaluate the efficacy and
safety of ABX464 given at 25 or 50 mg QD in inducing clinical remission in subjects with
moderately to severely active ulcerative colitis who have inadequate response, no
response, a loss of response, or an intolerance... expand
This is a multicenter, randomized, placebo controlled study to evaluate the efficacy and safety of ABX464 given at 25 or 50 mg QD in inducing clinical remission in subjects with moderately to severely active ulcerative colitis who have inadequate response, no response, a loss of response, or an intolerance to either conventional therapies [corticosteroids, immunosuppressant (i.e. azathioprine, 6-mercaptopurine, methotrexate)] and/or advanced therapies [biologics (TNF inhibitors, anti-integrins, anti-IL-23), and/or S1P receptor modulators, and/or JAK inhibitors]. Type: Interventional Start Date: Dec 2022 |
Genetic Testing to Select Therapy for the Treatment of Advanced or Metastatic Kidney Cancer, OPTIC RCC...
Advanced Clear Cell Renal Cell Carcinoma
Metastatic Clear Cell Renal Cell Carcinoma
Stage III Renal Cell Cancer AJCC v8
Stage IV Renal Cell Cancer AJCC v8
This phase II trial tests whether using genetic testing of tumor tissue to select the
optimal treatment regimen works in treating patients with clear cell renal cell (kidney)
cancer that has spread to other places in the body (advanced or metastatic). The current
Food and Drug Administration (FDA)-approved... expand
This phase II trial tests whether using genetic testing of tumor tissue to select the optimal treatment regimen works in treating patients with clear cell renal cell (kidney) cancer that has spread to other places in the body (advanced or metastatic). The current Food and Drug Administration (FDA)-approved regimens for advanced kidney cancer fall into two categories. One treatment combination includes two immunotherapy drugs (nivolumab plus ipilimumab), which are delivered by separate intravenous infusions into a vein. The other combination is one immunotherapy drug (nivolumab infusion) plus an oral pill taken by mouth (cabozantinib). Nivolumab and ipilimumab are "immunotherapies" which release the brakes of the immune system, thus allowing the patient's own immune system to better kill cancer cells. Cabozantinib is a "targeted therapy" specifically designed to block certain biological mechanisms needed for growth of cancer cells. In kidney cancer, cabozantinib blocks a tumor's blood supply. The genetic (DNA) makeup of the tumor may affect how well it responds to therapy. Testing the makeup (genes) of the tumor, may help match a treatment (from one of the above two treatment options) to the specific cancer and increase the chance that the disease will respond to treatment. The purpose of this study is to learn if genetic testing of tumor tissue may help doctors select the optimal treatment regimen to which advanced kidney cancer is more likely to respond. Type: Interventional Start Date: Dec 2022 |
Study of Tirabrutinib (ONO-4059) in Patients With Primary Central Nervous System Lymphoma (PROSPECT Study)
Refractory Primary Central Nervous System Lymphoma
Primary CNS Lymphoma
This study will evaluate the efficacy, safety, and pharmacokinetics of tirabrutinib
monotherapy in patients with relapsed or refractory PCNSL (Part A), and tirabrutinib in
combination with one of two different high dose methotrexate based regimens
(methotrexate/ temozolomide/rituximab or rituximab/methotrexate/procarbazine/
vincristine)... expand
This study will evaluate the efficacy, safety, and pharmacokinetics of tirabrutinib monotherapy in patients with relapsed or refractory PCNSL (Part A), and tirabrutinib in combination with one of two different high dose methotrexate based regimens (methotrexate/ temozolomide/rituximab or rituximab/methotrexate/procarbazine/ vincristine) as first line therapy in patients with newly diagnosed, treatment naïve PCNSL (Part B) Type: Interventional Start Date: Dec 2021 |
Study of TJ033721 in Subjects With Advanced or Metastatic Solid Tumors
Solid Tumor
Advanced Cancer
Metastatic Cancer
Gastric Cancer
Gastroesophageal Junction Carcinoma
This is an open label, multi-center, multiple dose Phase 1 study to evaluate the safety,
tolerability, MTD PK, and PD of TJ033721 in subjects with advanced or metastatic solid
tumors. expand
This is an open label, multi-center, multiple dose Phase 1 study to evaluate the safety, tolerability, MTD PK, and PD of TJ033721 in subjects with advanced or metastatic solid tumors. Type: Interventional Start Date: Jun 2021 |
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