Search Clinical Trials
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Study of Pembrolizumab (MK-3475) Plus Olaparib Versus Abiraterone Acetate or Enzalutamide in Metastatic...
Merck Sharp & Dohme Corp.
Prostatic Neoplasms
The purpose of this study is to assess the efficacy and safety of the combination of the
polyadenosine 5'-diphosphoribose poly(ADP-ribose) polymerase (PARP) inhibitor olaparib and
pembrolizumab in the treatment of participants with mCRPC who have failed to respond to
either... expand
The purpose of this study is to assess the efficacy and safety of the combination of the polyadenosine 5'-diphosphoribose poly(ADP-ribose) polymerase (PARP) inhibitor olaparib and pembrolizumab in the treatment of participants with mCRPC who have failed to respond to either abiraterone acetate or enzalutamide (but not both) and to chemotherapy. The primary study hypotheses are that the combination of pembrolizumab plus olaparib is superior to abiraterone acetate or enzalutamide with respect to: 1. Overall Survival (OS) and 2. Radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 as assessed by blinded independent central review (BICR) Type: Interventional Start Date: May 2019 |
Obinutuzumab With or Without Umbralisib, Lenalidomide, or Combination Chemotherapy in Treating Patients...
National Cancer Institute (NCI)
Grade 1 Follicular Lymphoma
Grade 2 Follicular Lymphoma
Grade 3a Follicular Lymphoma
Recurrent Follicular Lymphoma
Refractory Follicular Lymphoma
This phase II trial studies how well obinutuzumab with or without umbralisib, lenalidomide,
or combination chemotherapy work in treating patients with grade I-IIIa follicular lymphoma
that has come back (relapsed) or does not respond to treatment (refractory). Immunotherapy... expand
This phase II trial studies how well obinutuzumab with or without umbralisib, lenalidomide, or combination chemotherapy work in treating patients with grade I-IIIa follicular lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Immunotherapy with obinutuzumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Umbralisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as lenalidomide, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, prednisone, and bendamustine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving obinutuzumab with or without umbralisib, lenalidomide, or combination chemotherapy will work better in treating patients with grade I-IIIa follicular lymphoma. Type: Interventional Start Date: Aug 2017 |
Phase 4 Study of Obeticholic Acid Evaluating Clinical Outcomes in Patients With Primary Biliary Cholangitis
Intercept Pharmaceuticals
Liver Cirrhosis, Biliary
Primary Biliary Cholangitis (PBC) is a serious, life-threatening, bile acid related liver
disease of unknown cause. Without treatment, it frequently progresses to liver fibrosis and
eventual cirrhosis requiring liver transplantation or resulting in death. The investigational... expand
Primary Biliary Cholangitis (PBC) is a serious, life-threatening, bile acid related liver disease of unknown cause. Without treatment, it frequently progresses to liver fibrosis and eventual cirrhosis requiring liver transplantation or resulting in death. The investigational drug, Obeticholic Acid (OCA) is a modified bile acid and FXR agonist that is derived from the primary human bile acid chenodeoxycholic acid. The key mechanisms of action of OCA, including its choleretic, anti-inflammatory, and anti-fibrotic properties, underlie its hepatoprotective effects and result in attenuation of injury and improved liver function in a cholestatic liver disease such as PBC. The study will assess the effect of OCA compared to placebo, combined with stable standard care, on clinical outcomes in PBC patients. Type: Interventional Start Date: Dec 2014 |
WEAICOR: Wearables to Investigate the Long Term Cardiovascular and Behavioral Impacts of COVID-19
Tulane University
Covid19
Cardiovascular Complication
Behavioral Changes
This is an observational COVID-19 study that uses wearable health monitoring technology to
follow COVID-19 positive individuals to monitor persistent symptoms and any potential
long-term complications or cardiovascular and behavioral impacts from the disease.
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This is an observational COVID-19 study that uses wearable health monitoring technology to follow COVID-19 positive individuals to monitor persistent symptoms and any potential long-term complications or cardiovascular and behavioral impacts from the disease. Type: Observational [Patient Registry] Start Date: Jun 2020 |
Study of Oral Infigratinib for the Adjuvant Treatment of Subjects With Invasive Urothelial Carcinoma...
QED Therapeutics, Inc.
Upper Tract Urothelial Carcinomas
Urothelial Bladder Cancer
This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study to evaluate
the efficacy of giving an oral targeted FGFR1-3 inhibitor, infigratinib, as adjuvant
treatment following surgery in adult subjects with invasive urothelial carcinoma and
susceptible... expand
This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study to evaluate the efficacy of giving an oral targeted FGFR1-3 inhibitor, infigratinib, as adjuvant treatment following surgery in adult subjects with invasive urothelial carcinoma and susceptible FGFR3 genetic alterations (mutations, and gene fusions or translocations [ie, rearrangements) who have disease that is considered at high risk for recurrence with surgery alone. The study enrolls subjects with either bladder cancer post radical cystectomy or upper tract urothelial cancer post distal ureterectomy and/or nephrectomy. Study treatment is randomized between infigratinib or placebo with treatment until invasive local or distal disease recurrence. Type: Interventional Start Date: Mar 2020 |
Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer...
National Cancer Institute (NCI)
Bladder Adenocarcinoma
Bladder Clear Cell Adenocarcinoma
Bladder Mixed Adenocarcinoma
Bladder Neuroendocrine Carcinoma
Bladder Small Cell Neuroendocrine Carcinoma
This phase II trial studies how well cabozantinib works in combination with nivolumab and
ipilimumab in treating patients with rare genitourinary (GU) tumors that have spread to other
places in the body. Cabozantinib may stop the growth of tumor cells by blocking some of the... expand
This phase II trial studies how well cabozantinib works in combination with nivolumab and ipilimumab in treating patients with rare genitourinary (GU) tumors that have spread to other places in the body. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib, nivolumab, and ipilimumab may work better in treating patients with genitourinary tumors that have no treatment options compared to giving cabozantinib, nivolumab, or ipilimumab alone. Type: Interventional Start Date: Apr 2019 |
Assessing Physician and Hemophilia A Patient Reasons and Expectations for Switching Treatment to Kovaltry...
Bayer
Hemophilia A
This US study aims to assess hemophilia A patient characteristics and reasons for switching
from both patient/caregiver and physician perspectives. For this purpose, this research study
will include hemophilia A patients who have switched from an existing therapy to Kovaltry or... expand
This US study aims to assess hemophilia A patient characteristics and reasons for switching from both patient/caregiver and physician perspectives. For this purpose, this research study will include hemophilia A patients who have switched from an existing therapy to Kovaltry or Jivi. In doing so, real world evidence will be obtained from both patient and physician perspectives offering key insights for effective therapeutic management of patients with hemophilia A and to more fully understand what drives patient switching from a patient perspective and a physician perspective. Type: Observational Start Date: Aug 2018 |
A 5-year Longitudinal Observational Study of Patients With Nonalcoholic Fatty Liver (NAFL) or Nonalcoholic...
Target PharmaSolutions, Inc.
Nonalcoholic Fatty Liver
Nonalcoholic Steatohepatitis
TARGET-NASH is a longitudinal observational cohort study of patients being managed for NAFL
or NASH in usual clinical practice. TARGET-NASH will create a research registry of patients
with NAFL or NASH within academic and community real-world practices in order to assess the... expand
TARGET-NASH is a longitudinal observational cohort study of patients being managed for NAFL or NASH in usual clinical practice. TARGET-NASH will create a research registry of patients with NAFL or NASH within academic and community real-world practices in order to assess the safety and effectiveness of current and future therapies. Type: Observational [Patient Registry] Start Date: Jul 2016 |
Naloxone Hydrochloride Study for Relief of Pruritus in Patients With MF or SS Forms of CTCL
Elorac, Inc.
Mycosis Fungoides
Lymphoma, T-Cell, Cutaneous
Sézary Syndrome
This multi-center, double-blind, vehicle-controlled, randomized crossover design study will
evaluate the safety and efficacy of topically applied naloxone lotion, 0.5%, for the
treatment of pruritus in patients with the mycosis fungoides (MF) or Sézary syndrome (SS)
Forms... expand
This multi-center, double-blind, vehicle-controlled, randomized crossover design study will evaluate the safety and efficacy of topically applied naloxone lotion, 0.5%, for the treatment of pruritus in patients with the mycosis fungoides (MF) or Sézary syndrome (SS) Forms of Cutaneous T-cell Lymphoma (CTCL). This study will also determine if there is systemic absorption of the drug in a subset of subjects and if so, describe the range and mean plasma levels reached after two weeks of three time daily (TID) dosing. Funding Source - FDA OOPD Type: Interventional Start Date: Jan 2017 |
Study of Mavrilimumab (KPL-301) in Participants Hospitalized With Severe Corona Virus Disease 2019 (COVID-19)...
Kiniksa Pharmaceuticals, Ltd.
COVID
Interventional, randomized, double-blind, placebo-controlled study encompassing 2 development
phases (Phase 2 and Phase 3).
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Interventional, randomized, double-blind, placebo-controlled study encompassing 2 development phases (Phase 2 and Phase 3). Type: Interventional Start Date: Jul 2020 |
Clinical and Basic Investigations Into Congenital Disorders of Glycosylation
Mayo Clinic
Congenital Disorders of Glycosylation
The purpose of this research is to study the natural history of congenital disorders of
glycosylation and its causes and treatments.
expand
The purpose of this research is to study the natural history of congenital disorders of glycosylation and its causes and treatments. Type: Observational Start Date: Oct 2019 |
GRAVITAS-309: Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
Incyte Corporation
Chronic Graft-versus-host Disease
The purpose of this study is to assess the efficacy and safety of itacitinib in combination
with corticosteroids as first-line treatment for moderate or severe chronic graft-versus-host
disease (cGVHD).
expand
The purpose of this study is to assess the efficacy and safety of itacitinib in combination with corticosteroids as first-line treatment for moderate or severe chronic graft-versus-host disease (cGVHD). Type: Interventional Start Date: Jan 2019 |
Evaluating Safety & Efficacy of Apremilast in the Treatment of Cutaneous Disease in Patients With Recalcitrant...
Tulane University
Dermatomyositis, Adult Type
With limited treatment options available for dermatomyositis, the investigators hypothesize
that apremilast, a phosphodiesterase-4 (PDE-4) inhibitor, is a safe and efficacious add-on
treatment in patients with refractory cutaneous dermatomyositis.
The study will investigate... expand
With limited treatment options available for dermatomyositis, the investigators hypothesize that apremilast, a phosphodiesterase-4 (PDE-4) inhibitor, is a safe and efficacious add-on treatment in patients with refractory cutaneous dermatomyositis. The study will investigate the efficacy, safety and toxicity of apremilast given at 30 mg twice daily to patients with refractory cutaneous dermatomyositis. Clinical response will be assessed at 1 and 3 months. Patients will also be evaluated for durability of their response for up to 6 months. Treatment will be monitored with frequent clinical visits (0, 1, 3 and 6 months) and blood tests (CBC, CMP, creatine kinase, aldolase). Treatment will be discontinued at disease progression or unacceptable adverse events. Disease progression is defined as 4 points increase in the cutaneous dermatomyositis disease area and severity index (CDASI) score, worsening of muscle disease by manual muscle testing (MMT-8) score and 5 points increase in dermatomyositis life quality index (DLQI). 5 mm skin biopsies from lesional skin will be performed before treatment with apremilast and after 3 months of treatment for gene expression profiling and confirmatory immunohistochemical stains. Type: Interventional Start Date: Jun 2018 |
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children...
Duke University
Coronavirus Infection (COVID-19)
Pulmonary Arterial Hypertension
Urinary Tract Infections in Children
Hypertension
Pain
The study investigators are interested in learning more about how drugs, that are given to
children by their health care provider, act in the bodies of children and young adults in
hopes to find the most safe and effective dose for children. The primary objective of this
study... expand
The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider. Type: Observational Start Date: Mar 2020 |
Effect of Tumor Treating Fields (TTFields) (150 kHz) Concurrent With Standard of Care Therapies for Treatment...
NovoCure Ltd.
Nonsmall Cell Lung Cancer
The study is a prospective, randomized controlled phase III trial aimed to test the efficacy
and safety of TTFields, using the NovoTTF-100L System, concurrent with standard therapies for
stage 4 NSCLC patients, following progression while on or after platinum based treatment.The... expand
The study is a prospective, randomized controlled phase III trial aimed to test the efficacy and safety of TTFields, using the NovoTTF-100L System, concurrent with standard therapies for stage 4 NSCLC patients, following progression while on or after platinum based treatment.The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays. Type: Interventional Start Date: Dec 2016 |
Adolescent Master Protocol for Participants 18 Years of Age and Older (AMP Up)
Harvard School of Public Health
HIV/AIDS
This is a prospective cohort study designed to define the impact of HIV infection and
antiretroviral therapy (ART) on young adults with perinatal HIV infection as they transition
into adulthood. A group of perinatally HIV-exposed, -uninfected (PHEU) young adults from a
similar... expand
This is a prospective cohort study designed to define the impact of HIV infection and antiretroviral therapy (ART) on young adults with perinatal HIV infection as they transition into adulthood. A group of perinatally HIV-exposed, -uninfected (PHEU) young adults from a similar sociodemographic background and age distribution will be enrolled for comparison. Type: Observational Start Date: Apr 2014 |
Study of F-652 (IL-22:IgG2 Fusion Protein) in Patients With Moderate to Severe COVID-19
Generon (Shanghai) Corporation Ltd.
Covid19
This is an interventional, multicenter, 2-arm, parallel-group, randomized, double-blind,
placebo controlled, dose-escalation, safety and efficacy study of F-652 treatment versus
placebo in patients aged 18 years or older with a COVID-19 diagnosis confirmed by PCR.
Eligible... expand
This is an interventional, multicenter, 2-arm, parallel-group, randomized, double-blind, placebo controlled, dose-escalation, safety and efficacy study of F-652 treatment versus placebo in patients aged 18 years or older with a COVID-19 diagnosis confirmed by PCR. Eligible patients will have moderate to severe COVID-19 symptoms within 5 days post hospitalization and a positive COVID-19 testing. Type: Interventional Start Date: Dec 2020 |
A Study of TL-895 With Standard Available Treatment Versus Standard Available Treatment for the Treatment...
Telios Pharma, Inc.
COVID-19
Sars-CoV2
Cancer
Solid Tumor
Carcinoma
This study evaluates TL-895, a tyrosine kinase inhibitor (TKI). This is a 2-part study
comprising a Phase 1 safety lead-in (Part 1) that will determine the recommended TL-895 dose
for Phase 2 (Part 2).
In Part 1, TL-895 open-label will be administered orally at an assigned... expand
This study evaluates TL-895, a tyrosine kinase inhibitor (TKI). This is a 2-part study comprising a Phase 1 safety lead-in (Part 1) that will determine the recommended TL-895 dose for Phase 2 (Part 2). In Part 1, TL-895 open-label will be administered orally at an assigned dose continuously in 7-day cycles for 2 cycles. Up to 3 dose levels will be evaluated. In Part 2, eligible subjects will be randomized in a 1:1 ratio to TL-895 with standard available treatment (SAT), or placebo with SAT. Investigators and Sponsor will be blinded to each subject's assigned study intervention throughout the course of the study. Type: Interventional Start Date: Jul 2020 |
Nivolumab and Ipilimumab in Treating Patients With Rare Tumors
National Cancer Institute (NCI)
Acinar Cell Carcinoma
Adenoid Cystic Carcinoma
Adrenal Cortex Carcinoma
Adrenal Gland Pheochromocytoma
Anal Canal Neuroendocrine Carcinoma
This phase II trial studies nivolumab and ipilimumab in treating patients with rare tumors.
Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the
body's immune system attack the cancer, and may interfere with the ability of tumor cells to... expand
This phase II trial studies nivolumab and ipilimumab in treating patients with rare tumors. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial enrolls participants for the following cohorts based on condition: 1. Epithelial tumors of nasal cavity, sinuses, nasopharynx: A) Squamous cell carcinoma with variants of nasal cavity, sinuses, and nasopharynx and trachea (excluding laryngeal, nasopharyngeal cancer [NPC], and squamous cell carcinoma of the head and neck [SCCHN]) B) Adenocarcinoma and variants of nasal cavity, sinuses, and nasopharynx (closed to accrual 07/27/2018) 2. Epithelial tumors of major salivary glands (closed to accrual 03/20/2018) 3. Salivary gland type tumors of head and neck, lip, esophagus, stomach, trachea and lung, breast and other location (closed to accrual) 4. Undifferentiated carcinoma of gastrointestinal (GI) tract 5. Adenocarcinoma with variants of small intestine (closed to accrual 05/10/2018) 6. Squamous cell carcinoma with variants of GI tract (stomach small intestine, colon, rectum, pancreas) (closed to accrual 10/17/2018) 7. Fibromixoma and low grade mucinous adenocarcinoma (pseudomixoma peritonei) of the appendix and ovary (closed to accrual 03/20/2018) 8. Rare pancreatic tumors including acinar cell carcinoma, mucinous cystadenocarcinoma or serous cystadenocarcinoma. Pancreatic adenocarcinoma is not eligible 9. Intrahepatic cholangiocarcinoma (closed to accrual 03/20/2018) 10. Extrahepatic cholangiocarcinoma and bile duct tumors (closed to accrual 03/20/2018) 11. Sarcomatoid carcinoma of lung 12. Bronchoalveolar carcinoma lung. This condition is now also referred to as adenocarcinoma in situ, minimally invasive adenocarcinoma, lepidic predominant adenocarcinoma, or invasive mucinous adenocarcinoma 13. Non-epithelial tumors of the ovary: A) Germ cell tumor of ovary B) Mullerian mixed tumor and adenosarcoma (closed to accrual 03/30/2018) 14. Trophoblastic tumor: A) Choriocarcinoma (closed to accrual) 15. Transitional cell carcinoma other than that of the renal, pelvis, ureter, or bladder (closed to accrual) 16. Cell tumor of the testes and extragonadal germ tumors: A) Seminoma and testicular sex cord cancer B) Non seminomatous tumor C) Teratoma with malignant transformation (closed to accrual) 17. Epithelial tumors of penis - squamous adenocarcinoma cell carcinoma with variants of penis 18. Squamous cell carcinoma variants of the genitourinary (GU) system 19. Spindle cell carcinoma of kidney, pelvis, ureter 20. Adenocarcinoma with variants of GU system (excluding prostate cancer) (closed to accrual 07/27/2018) 21. Odontogenic malignant tumors 22. Pancreatic neuroendocrine tumor (PNET) (formerly named: Endocrine carcinoma of pancreas and digestive tract.) (closed to accrual) 23. Neuroendocrine carcinoma including carcinoid of the lung (closed to accrual 12/19/2017) 24. Pheochromocytoma, malignant (closed to accrual) 25. Paraganglioma (closed to accrual 11/29/2018) 26. Carcinomas of pituitary gland, thyroid gland parathyroid gland and adrenal cortex (closed to accrual) 27. Desmoid tumors 28. Peripheral nerve sheath tumors and NF1-related tumors (closed to accrual 09/19/2018) 29. Malignant giant cell tumors 30. Chordoma (closed to accrual 11/29/2018) 31. Adrenal cortical tumors (closed to accrual 06/27/2018) 32. Tumor of unknown primary (Cancer of Unknown Primary; CuP) (closed to accrual 12/22/2017) 33. Not Otherwise Categorized (NOC) Rare Tumors [To obtain permission to enroll in the NOC cohort, contact: S1609SC@swog.org] (closed to accrual 03/15/2019) 34. Adenoid cystic carcinoma (closed to accrual 02/06/2018) 35. Vulvar cancer (temporarily closed to accrual) 36. MetaPLASTIC carcinoma (of the breast) (closed to accrual) 37. Gastrointestinal stromal tumor (GIST) (closed to accrual 09/26/2018) 38. Perivascular epithelioid cell tumor (PEComa) 39. Apocrine tumors/extramammary Paget's disease (closed to accrual) 40. Peritoneal mesothelioma (temporarily closed to accrual 05/08/2020) 41. Basal cell carcinoma (temporarily closed to accrual 04/29/2020) 42. Clear cell cervical cancer 43. Esthenioneuroblastoma (closed to accrual) 44. Endometrial carcinosarcoma (malignant mixed Mullerian tumors) (closed to accrual) 45. Clear cell ovarian cancer (closed to accrual) 46. Gestational trophoblastic disease (GTD) 47. Gallbladder cancer 48. Small cell carcinoma of the ovary, hypercalcemic type 49. PD-L1 amplified tumors 50. Angiosarcoma 51. High-grade neuroendocrine carcinoma (pancreatic neuroendocrine tumor [PNET] should be enrolled in Cohort 22; prostatic neuroendocrine carcinomas should be enrolled into Cohort 52). Small cell lung cancer is not eligible (temporarily closed to accrual 03/25/2020) 52. Treatment-emergent small-cell neuroendocrine prostate cancer (t-SCNC) Type: Interventional Start Date: Jan 2017 |
Helping Stroke Patients With ThermoSuit Cooling
Life Recovery Systems
Stroke
Brain Ischemia
The aim of this study is to assess the feasibility of using the Life Recovery Systems
ThermoSuit Device to induce therapeutic hypothermia (32-34°C) in victims of ischemic stroke.
This feasibility clinical study will enroll a total of 30 patients with acute ischemic stroke... expand
The aim of this study is to assess the feasibility of using the Life Recovery Systems ThermoSuit Device to induce therapeutic hypothermia (32-34°C) in victims of ischemic stroke. This feasibility clinical study will enroll a total of 30 patients with acute ischemic stroke at four clinical centers. Subjects will receive hypothermia plus conventional therapy (such as IV-tPA and/or neurothrombectomy therapies if indicated). Endpoints will include feasibility of cooling, adverse events, and neurological recovery in comparison with matched historical controls. Type: Interventional Start Date: Jan 2017 |
The INSPIRE-ASP PNA Trial
Harvard Pilgrim Health Care
Pneumonia
The INSPIRE-ASP PNA trial is a cluster-randomized controlled trial of HCA hospitals comparing
routine empiric antibiotic stewardship practices with real-time precision medicine
computerized physician order entry smart prompts providing the probability that a
non-critically... expand
The INSPIRE-ASP PNA trial is a cluster-randomized controlled trial of HCA hospitals comparing routine empiric antibiotic stewardship practices with real-time precision medicine computerized physician order entry smart prompts providing the probability that a non-critically ill adult admitted with PNA is infected with a resistant pathogen. Note: that enrolled "subjects" represents 59 individual HCA hospitals that have been randomized. Type: Interventional Start Date: Oct 2018 |
Durvalumab and Tremelimumab in Treating Patients With Recurrent Stage IV Lung Cancer
Southwest Oncology Group
Recurrent Squamous Cell Lung Carcinoma
Stage IV Squamous Cell Lung Carcinoma AJCC v7
This phase II trial studies how well durvalumab and tremelimumab works in treating patients
with stage IV lung cancer that has come back after previous treatment. Monoclonal antibodies,
such as durvalumab and tremelimumab, may interfere with the ability of tumor cells to grow... expand
This phase II trial studies how well durvalumab and tremelimumab works in treating patients with stage IV lung cancer that has come back after previous treatment. Monoclonal antibodies, such as durvalumab and tremelimumab, may interfere with the ability of tumor cells to grow and spread. Type: Interventional Start Date: Oct 2017 |
Check it: A New Approach to Controlling Chlamydia Transmission in Young People
Tulane University
Chlamydia Trachomatis Infection
Gonorrhea
This study, named "Check it," is a bundled program for African American (AA) men ages 15-24
that includes community testing for chlamydia and gonorrhea, expedited treatment for subjects
who test positive and their female sexual contacts, and rescreening for these two sexually... expand
This study, named "Check it," is a bundled program for African American (AA) men ages 15-24 that includes community testing for chlamydia and gonorrhea, expedited treatment for subjects who test positive and their female sexual contacts, and rescreening for these two sexually transmitted infections. Type: Interventional Start Date: May 2017 |
Apalutamide and Abiraterone Acetate in African American and Caucasian Men With Metastatic Castrate Resistant...
Daniel George, MD
Prostate Cancer
The primary goal is to prospectively estimate the median PFS of African American and
Caucasian men with mCRPC taking apalutamide, abiraterone acetate, and prednisone. Secondary
objectives include: PSA kinetics: to determine the duration of PSA response, time to nadir,
and... expand
The primary goal is to prospectively estimate the median PFS of African American and Caucasian men with mCRPC taking apalutamide, abiraterone acetate, and prednisone. Secondary objectives include: PSA kinetics: to determine the duration of PSA response, time to nadir, and percent of men who achieve a PSA < 0.1; Radiographic assessments: to estimate the rate of objective response and incidence of bone flares; Safety (NCI CTC v4.0) and tolerability, particularly incidence and grade of hypertension in the two populations. This is a non-comparative pilot open-label, parallel arm, multicenter study of apalutamide and abiraterone acetate in African American and Caucasian men with mCRPC. It is anticipated that 3 additional sites will be needed to accrue 100 subjects (50 African American and 50 Caucasian) over a 24 month accrual period. The study agents will be administerd at the following doses: apalutamide 240mg orally once daily, abiraterone acetate 1000mg orally once daily, and prednisone 5 mg BID in 4-week cycles throughout the treatment period. Fifty (50) patients will be enrolled in each group (AA and Caucasians). The proportion of patients who experience PSA decline of 30%, 50% and 90% will be estimated with exact 95% confidence intervals based on the binomial distribution will be computed. In addition, post therapy changes in PSA will be explored as a continuous outcome. The Kaplan-Meier product limit method will be used to estimate the rPFS, biochemical PFS and overall survival distributions. Type: Interventional Start Date: Jul 2017 |
Phase ll Study of Pirfenidone in Patients With RAILD (TRAIL1)
Ivan O. Rosas
Rheumatoid Arthritis Interstitial Lung Disease
The purpose of this study is to to assess the safety and tolerability of pirfenidone 2403
mg/day for the treatment of RA-associated interstitial lung disease.
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The purpose of this study is to to assess the safety and tolerability of pirfenidone 2403 mg/day for the treatment of RA-associated interstitial lung disease. Type: Interventional Start Date: Apr 2017 |