| 1 |
NCT03462680 |
Recruiting |
GPR109A and Parkinson's Disease: Role of Niacin in Outcome Measures |
|
- Dietary Supplement: niacin
- Other: placebo
|
Interventional |
Not Applicable |
- VA Office of Research and Development
|
U.S. Fed |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Health Services Research
|
- Unified Parkinson's Disease Rating Scale (UPDRS) change
- Mini-Mental State Examination (MMSE) change
- Stroop test change
- (and 4 more...)
|
80 |
All |
35 Years and older (Adult, Senior) |
NCT03462680 |
N1613-I |
|
September 28, 2016 |
September 30, 2019 |
September 30, 2019 |
March 12, 2018 |
March 13, 2018 |
|
- Charlie Norwood VA Medical Center, Augusta, GA
Augusta, Georgia, United States
|
| 2 |
NCT03260166 |
Recruiting |
Nicotinamide Treatment for Lupus-associated Skin Lesions in Lupus Erythematosus |
- Cutaneous Lupus Erythematosus
- Systemic Lupus Erythematosus Rash
|
|
Interventional |
Phase 2 |
- Second Xiangya Hospital of Central South University
- National Natural Science Foundation of China
- Hunan Provincial Natural Science Foundation of China
- National Key Clinical Specialty Construction Project of China
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- A change in Revised Cutaneous Lupus Erythematosus Disease Area and Severity Index (RCLASI) activity score
- A change in RCLASI activity score
- Response Rate and Remarkable Response Rate at 1, 2, 3, 4, and 6 months, respectively
- (and 11 more...)
|
40 |
All |
18 Years to 65 Years (Adult) |
NCT03260166 |
PFK201707 |
|
August 31, 2017 |
August 2018 |
February 2019 |
August 24, 2017 |
September 25, 2017 |
|
- The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
|
| 3 |
NCT01984073 |
Recruiting |
Effects of Niacin On Fatty Acid Trapping |
|
- Drug: ER Niacin Oral Fat Challenge
- Drug: IR Niacin Oral Fat Challenge
- Other: Placebo Oral Fat Challenge
|
Interventional |
Phase 1 |
- University of Pennsylvania
- National Heart, Lung, and Blood Institute (NHLBI)
- Arizona Pharmaceuticals Inc.
|
Other / NIH / Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Other
|
|
20 |
All |
22 Years to 75 Years (Adult, Senior) |
NCT01984073 |
NOFAT
K23HL091130 |
NOFAT |
December 2012 |
October 2018 |
October 2018 |
November 14, 2013 |
May 1, 2017 |
|
- Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States - Presbyterian Hospital
Philadelphia, Pennsylvania, United States
|
| 4 |
NCT03432871 |
Recruiting |
Nicotinamide Riboside and Mitochondrial Biogenesis |
- Mitochondrial Diseases
- Mitochondrial Myopathies
- Progressive External Ophthalmoplegia
- (and 6 more...)
|
- Dietary Supplement: Nicotinamide Riboside
|
Interventional |
Not Applicable |
- Cambridge University Hospitals NHS Foundation Trust
- University of Cambridge
- MRC Mitochondrial Biology Unit
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Bioavailability
- Safety - Incidence of treatment related adverse events
- Safety - change in blood analytes
- (and 10 more...)
|
15 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT03432871 |
A094351 |
|
December 8, 2017 |
December 31, 2018 |
May 30, 2019 |
February 14, 2018 |
March 16, 2018 |
|
- Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom
|
| 5 |
NCT02322203 |
Recruiting |
Effects of Niacin Therapy on Lipoprotein Composition and Function |
|
- Dietary Supplement: Niacin Extended Release
|
Interventional |
Phase 2 |
- National Heart, Lung, and Blood Institute (NHLBI)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Changes in protein or lipid composition of any lipoprotein fraction and changes in vascular compliance as measured by CAVI
|
200 |
All |
18 Years to 99 Years (Adult, Senior) |
NCT02322203 |
150042
15-H-0042 |
|
December 20, 2014 |
April 7, 2019 |
July 3, 2019 |
December 23, 2014 |
March 2, 2018 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
| 6 |
NCT02836184 |
Recruiting |
Nicotinic Acid in Hemodialysis Patients With Hyperphosphatemia |
|
- Drug: Nicotinic Acids
- Drug: Calcium Carbonate
|
Interventional |
Phase 4 |
- Jiujiang No.1 People's Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Triple (Participant, Care Provider, Outcomes Assessor)
- Primary Purpose: Treatment
|
- change in serum phosphorus
- change in serum calcium
- change in serum calcium-phosphorus product
- (and 12 more...)
|
45 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT02836184 |
2016075 |
NAHPH |
July 2016 |
September 2016 |
September 2016 |
July 18, 2016 |
August 30, 2016 |
|
- Jiujiang NO.1 People's Hospital
Jiujiang, Jiangxi, China
|
| 7 |
NCT03419364 |
Recruiting |
Study of Nicotinamide in Early Onset Preeclampsia |
|
|
Interventional |
Phase 2 |
- University of North Carolina, Chapel Hill
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in Mean Arterial blood Pressure (MAP)
- Number of participants with alanine aminotransferase (ALT) =/> 3x Upper Limit of Normal (ULN)
- Number of participants with aspartate aminotransferase (AST) =/> 3x Upper Limit of Normal (ULN)
- (and 7 more...)
|
25 |
Female |
18 Years to 55 Years (Adult) |
NCT03419364 |
17-0693
1R03HD092370-01 |
|
November 1, 2017 |
December 31, 2019 |
December 31, 2019 |
February 1, 2018 |
February 1, 2018 |
|
- UNC at Chapel Hill
Chapel Hill, North Carolina, United States
|
| 8 |
NCT03061474 |
Recruiting |
Nicotinamide as an Early Alzheimer's Disease Treatment |
- Alzheimer's Disease
- Mild Cognitive Impairment
|
- Drug: Nicotinamide
- Drug: Placebo Comparator
|
Interventional |
Phase 2 |
- University of California, Irvine
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Change in p-tau 231
- Change in p-tau 181
- Change in total tau
|
48 |
All |
50 Years and older (Adult, Senior) |
NCT03061474 |
20163246 |
NEAT |
July 12, 2017 |
February 28, 2019 |
February 28, 2019 |
February 23, 2017 |
February 15, 2018 |
|
- University of California, Irvine
Irvine, California, United States - University of California, Los Angeles
Los Angeles, California, United States
|
| 9 |
NCT03501433 |
Recruiting
New |
Effects of Nicotinamide Riboside on Metabolism and Vascular Function |
|
- Dietary Supplement: Nicotinamide riboside chloride (Niagen)
- Dietary Supplement: Placebo
|
Interventional |
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Double (Participant, Outcomes Assessor)
- Primary Purpose: Basic Science
|
- NAD+
- Vasodilatory responsiveness
- Lipdemia
- Oxidative stress and inflammation
|
40 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT03501433 |
17-603 |
|
February 1, 2018 |
December 2018 |
December 2018 |
April 18, 2018 |
April 18, 2018 |
|
- Iowa State University
Ames, Iowa, United States
|
| 10 |
NCT03163576 |
Not yet recruiting |
The Efficacy of Niacin on Hyperphosphatemia in Patients Undergoing Haemodialysis |
|
- Drug: Niacin
- Drug: Phosphate Binder
|
Interventional |
Phase 4 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- the level of phosphorous level in haemodialysis patients treated by niacin
|
150 |
All |
18 Years to 60 Years (Adult) |
NCT03163576 |
ENPD |
|
June 2017 |
June 2019 |
December 2019 |
May 23, 2017 |
May 23, 2017 |
|
|
| 11 |
NCT03423342 |
Recruiting |
Nicotinamide Riboside in Systolic Heart Failure |
|
- Dietary Supplement: nicotinamide riboside
- Drug: Placebo
|
Interventional |
Phase 1
Phase 2 |
- University of Washington
- National Heart, Lung, and Blood Institute (NHLBI)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Other
|
- Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
- Effect of NR on Whole Blood NAD+ Levels
- Number of Participants with Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
- Effect of NR on Mitochondrial Function
|
30 |
All |
18 Years and older (Adult, Senior) |
NCT03423342 |
STUDY00001830
1R21HL126209-01 |
|
May 19, 2016 |
May 1, 2018 |
June 30, 2018 |
February 6, 2018 |
February 6, 2018 |
|
- University of Washington
Seattle, Washington, United States
|
| 12 |
NCT03151707 |
Not yet recruiting |
The Effects of Nicotinamide Riboside Supplementation on NAD+/NADH Ratio and Bioenergetics |
|
- Drug: Nicotinamide Riboside
|
Interventional |
Phase 4 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change from baseline to the end of treatment in brain NAD+/NADH ratio
- Change from baseline to the end of treatment in brain phosphocreatine (PCr) to adenosine triphosphate (ATP) ratio (PCr/ATP)
- Change from baseline to the end of treatment in creatine kinase (CK) enzyme rate
|
60 |
All |
18 Years to 65 Years (Adult) |
NCT03151707 |
2017P000006 |
|
October 2017 |
July 2019 |
July 2019 |
May 12, 2017 |
September 1, 2017 |
|
|
| 13 |
NCT02416739 |
Recruiting |
Anticancer Activity of Nicotinamide on Lung Cancer |
- Non-Small-Cell Lung Carcinoma
|
|
Interventional |
Phase 2
Phase 3 |
- Il Yeong Park, Ph.D.
- Chungbuk National University
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Hazard ratio (PFS) of the nicotinamide arm to the placebo arm
- Response rate
- Quality of life
- Overall survival
|
110 |
All |
18 Years and older (Adult, Senior) |
NCT02416739 |
Amina-X-002 |
|
March 2015 |
February 2019 |
February 2019 |
April 15, 2015 |
April 4, 2017 |
|
- Chonnam National University Hwasun Hospital
Hwasun, Chonnam, Korea, Republic of
|
| 14 |
NCT03356483 |
Not yet recruiting |
Efficacy of Psilocybin in OCD: a Double-Blind, Placebo-Controlled Study. |
- Obsessive-Compulsive Disorder
|
- Drug: Psilocybin (0.25mg/kg)
- Drug: Niacin (250mg)
|
Interventional |
Phase 2 |
- Yale University
- Heffter Research Institute
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Changes in severity of OCD symptoms, which will be measured by The Yale-Brown Obsessive-Compulsive Scale (Y-BOCS). The Primary Outcome Measure will be collected at baseline and 48 hours, assessing change from baseline at 48 hours.
- Acute Yale-Brown Obsessive-Compulsive Scale (A-YBOCS)
- Changes in brain connectivity, which will be measured with functional Magnetic Imaging Resonance (fMRI).
- (and 21 more...)
|
30 |
All |
21 Years to 55 Years (Adult) |
NCT03356483 |
2000020355 |
|
April 2, 2018 |
January 2022 |
July 2022 |
November 29, 2017 |
March 19, 2018 |
|
- Connecticut Mental Health Center
New Haven, Connecticut, United States
|
| 15 |
NCT02950441 |
Recruiting |
Nicotinamide Adenine Dinucleotide and Skeletal Muscle Metabolic Phenotype |
|
- Dietary Supplement: Nicotinamide Riboside
- Other: Placebo
|
Interventional |
Phase 2 |
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Mitochondrial function assessment in skeletal muscle using high resolution respirometry
- Skeletal muscle NAD+ levels in vastus lateralis biopsy using targeted metabolomics
- Improvement in response to oral glucose tolerance test/HOMA-IR
- (and 6 more...)
|
12 |
Male |
70 Years to 80 Years (Senior) |
NCT02950441 |
RG_15-152 |
NADMet |
June 2016 |
September 2018 |
September 2019 |
November 1, 2016 |
June 7, 2017 |
|
- University Hospitals Birmingham NHS Foundation Trust
Birmingham, West Midlands, United Kingdom
|
| 16 |
NCT02835664 |
Recruiting |
Nicotinamide Riboside and Metabolic Health |
- Obesity
- Insulin Resistance
|
- Dietary Supplement: Nicotinamide Riboside (Niagen)
- Dietary Supplement: Placebo
|
Interventional |
Not Applicable |
- Maastricht University Medical Center
- Dutch Heart Foundation
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Insulin sensitivity: muscle- and liver specific
- Muscle mitochondrial function (ex vivo)
- Ectopic lipid accumulation
- (and 5 more...)
|
15 |
All |
45 Years to 65 Years (Adult) |
NCT02835664 |
NL58119.068.16 |
|
December 2016 |
December 2018 |
December 2018 |
July 18, 2016 |
April 6, 2018 |
|
- Maastricht University Medical Centre
Maastricht, Netherlands
|
| 17 |
NCT02109614 |
Recruiting |
Early Aortic Valve Lipoprotein(a) Lowering Trial |
- Aortic Stenosis and Lipoprotein(a) Levels
|
- Drug: Extended release Niacin
- Drug: Placebo Comparator
|
Interventional |
Early Phase 1 |
- George Thanassoulis
- Jewish General Hospital
- Laval University
- (and 2 more...)
|
Other |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Prevention
|
- Calcium score progression by cardiac CT in individuals randomized to niacin as compared to those randomized to placebo
- Mean change in Lp(a) levels between treatment arms
|
238 |
All |
50 Years to 85 Years (Adult, Senior) |
NCT02109614 |
A00-M105-13A |
EAVaLL |
May 2014 |
January 2017 |
September 2017 |
April 10, 2014 |
September 13, 2016 |
|
- MUHC - Montreal General Hospital
Montreal, Quebec, Canada - MUHC - Royal Victoria Hospital
Montreal, Quebec, Canada - Jewish General Hospital
Montreal, Quebec, Canada
|
| 18 |
NCT02812238 |
Recruiting |
Study to Evaluate the Effect of Nicotinamide Riboside on Immunity |
- Atherosclerosis
- Diabetes
- Coronary Artery Disease
|
- Dietary Supplement: Nicotinamide riboside (NR)
- Other: Placebo
|
Interventional |
Phase 2 |
- National Heart, Lung, and Blood Institute (NHLBI)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Basic Science
|
- The refeeding IL-1 secretion in response to inflammasome stimulation in the NR treatment arm versus the same subject's response on the placebo treatment arm using paired t-test analyses
|
42 |
All |
18 Years to 39 Years (Adult) |
NCT02812238 |
160129
16-H-0129 |
|
June 23, 2016 |
May 31, 2018 |
March 5, 2019 |
June 24, 2016 |
April 17, 2018 |
|
- National Institutes of Health Clinical Center
Bethesda, Maryland, United States
|
| 19 |
NCT02702492 |
Recruiting |
PAK4 and NAMPT in Patients With Solid Malignancies or NHL (PANAMA) |
|
- Drug: KPT-9274
- Drug: KPT-9274 & Niacin ER
|
Interventional |
Phase 1 |
- Karyopharm Therapeutics Inc
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
|
175 |
All |
18 Years and older (Adult, Senior) |
NCT02702492 |
KCP-9274-901 |
PANAMA |
June 2016 |
June 2019 |
November 2019 |
March 8, 2016 |
January 25, 2018 |
|
- University of Colorado Cancer Center
Aurora, Colorado, United States - Georgetown University, Lombardi Comprehensive Cancer Center
Washington, District of Columbia, United States - Mayo Clinic Rochester
Rochester, Minnesota, United States - (and 4 more...)
|
| 20 |
NCT02942888 |
Recruiting |
The Effects of Nicotinamide Adenine Dinucleotide (NAD) on Brain Function and Cognition |
- Mild Cognitive Impairment
- NAD
|
- Dietary Supplement: Nicotinamide riboside
- Dietary Supplement: Sugar Pill
|
Interventional |
Not Applicable |
- The University of Texas Health Science Center at San Antonio
- University of Texas
- South Texas Veterans Health Care System
|
Other / U.S. Fed |
- Allocation: Randomized
- Intervention Model: Factorial Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Basic Science
|
- Change in Cognitive Assessment - Montreal Cognitive Assessment (MoCA) - from baseline at 10 weeks
- Change in cerebral blood flow from baseline at 10 weeks
- Change in plasma NAD from baseline at 10 weeks
- (and 9 more...)
|
26 |
All |
65 Years and older (Adult, Senior) |
NCT02942888 |
HSC20160350H |
NAD |
November 30, 2017 |
December 2018 |
December 2018 |
October 24, 2016 |
January 9, 2018 |
|
- South Texas Veterans Healthcare System (STVHCS)
San Antonio, Texas, United States - University of Texas Health San Antonio
San Antonio, Texas, United States
|
| 21 |
NCT02721537 |
Recruiting |
Use of 31P MRS to Assess Brain NAD+ in Healthy Collegiate Athletes |
|
- Dietary Supplement: Nicotinamide Riboside
- Other: Matching placebo
|
Interventional |
Not Applicable |
- Mayo Clinic
- University of Minnesota - Clinical and Translational Science Institute
- Thorne Research Inc.
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Screening
|
- Change in brain NAD+ levels
|
48 |
All |
18 Years and older (Adult, Senior) |
NCT02721537 |
15-006870 |
TRMC-004 |
September 2016 |
December 2018 |
June 2019 |
March 29, 2016 |
February 23, 2018 |
|
- University of Minnesota Center for Magnetic Resonance Research
Minneapolis, Minnesota, United States - Mayo Clinic
Rochester, Minnesota, United States
|
| 22 |
NCT03176628 |
Recruiting |
Pharmacokinetics, Pharmacodynamics and Safety of Basis in Acute Kidney Injury Study |
|
- Dietary Supplement: Basis
- Dietary Supplement: Placebo
|
Interventional |
Not Applicable |
- Massachusetts General Hospital
- Elysium Health
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Other
|
- Maximum plasma concentration [Cmax] of NR
- Maximum plasma concentration [Cmax] of pterostilbene
- Area Under the Curve [AUC] of NR
- (and 6 more...)
|
24 |
All |
18 Years and older (Adult, Senior) |
NCT03176628 |
2017P000908 |
BAKIS |
November 1, 2017 |
October 31, 2018 |
October 31, 2018 |
June 5, 2017 |
March 27, 2018 |
|
- Massachusetts General Hospital
Boston, Massachusetts, United States
|
| 23 |
NCT02808182 |
Recruiting |
Postprandial Fatty Acid Metabolism in the Natural History of Type 2 Diabetes (T2D) |
- Impaired Glucose Tolerance
|
- Drug: Nicotinic acid
- Other: [7,7,8,8-2H]-palmitate
- Other: [U-13C]-palmitate
- (and 2 more...)
|
Interventional |
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Plasma NEFA appearance rate
- Cardiac uptake
- WAT spillover NEFA appearance rates
- (and 9 more...)
|
40 |
All |
45 Years to 65 Years (Adult) |
NCT02808182 |
2016-1196 |
AGL11 |
January 17, 2017 |
May 2018 |
February 2019 |
June 21, 2016 |
February 7, 2017 |
|
- centre de recherche du CHUS
Sherbrooke, Quebec, Canada
|
| 24 |
NCT03151239 |
Recruiting |
Effect of "Nicotinamide Mononucleotide" (NMN) on Cardiometabolic Function |
- Glucose Metabolism Disorders
|
- Dietary Supplement: NMN supplement
- Other: Placebo
|
Interventional |
Not Applicable |
- Washington University School of Medicine
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Basic Science
|
- To determine change in insulin sensitivity.
- To determine change in beta-cell function.
|
50 |
Female |
55 Years to 70 Years (Adult, Senior) |
NCT03151239 |
201701096 |
NMN |
July 1, 2017 |
June 1, 2019 |
June 1, 2020 |
May 12, 2017 |
August 3, 2017 |
|
- Washington University School of Medicine
Saint Louis, Missouri, United States
|
| 25 |
NCT03268902 |
Recruiting |
Early Life Interventions for Childhood Growth and Development In Tanzania |
- Malnutrition
- Stunting
- Cognitive Development
- Enteric Pathogens
|
- Drug: Azithromycin Oral Liquid Product
- Drug: Nitazoxanide Oral Suspension
- Dietary Supplement: Nicotinamide
- Drug: Placebos
|
Interventional |
Phase 2
Phase 3 |
- Haydom Lutheran Hospital
- University of Virginia
- Bill and Melinda Gates Foundation
|
Other |
- Allocation: Randomized
- Intervention Model: Factorial Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Height-for-age z-score (HAZ) at 18 months
- Weight-for-age z-score (WAZ) at 18 months
- Head circumference-for-age z-score (HCAZ) at 18 months
- (and 16 more...)
|
1188 |
All |
up to 14 Days (Child) |
NCT03268902 |
19465 |
ELICIT |
September 5, 2017 |
September 2020 |
December 2020 |
August 31, 2017 |
September 12, 2017 |
|
- Haydom Lutheran Hospital
Haydom, Manyara, Tanzania
|
| 26 |
NCT03482167 |
Not yet recruiting
New |
NAD+ Therapy for Improving Memory and Cerebrovascular Function in Patients With MCI |
- Mild Cognitive Impairment
|
- Drug: Niagen®
- Other: Placebo
|
Interventional |
Phase 1
Phase 2 |
- University of Delaware
- National Institute on Aging (NIA)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Change from baseline in cognitive scores at 12 weeks
- Change from baseline in cerebrovascular reactivity at 12 weeks
- Change from baseline in total brain blood flow at 12 weeks
- (and 2 more...)
|
58 |
All |
60 Years to 90 Years (Adult, Senior) |
NCT03482167 |
1079271-1
K01AG054731 |
|
June 2018 |
March 2022 |
March 2022 |
March 29, 2018 |
March 29, 2018 |
|
- Neurovascular Aging Laboratory
Newark, Delaware, United States
|
| 27 |
NCT03019666 |
Recruiting |
Ph I Trial of NAM NK Cells and IL-2 for Adult Pts With MM and NHL |
- Multiple Myeloma
- Non-Hodgkin Lymphoma
- Diffuse Large B Cell Lymphoma
- (and 5 more...)
|
- Biological: Nicotinamide Expanded Haploidentical or Mismatched Related Donor Natural Killer Cells
|
Interventional |
Phase 1 |
- Masonic Cancer Center, University of Minnesota
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Occurrence of any grade 4 or greater suspected adverse reaction
- Occurrence of Grade III or IV acute graft-versus-host disease (aGVHD)
- Occurrence of treatment related mortality (TRM)
- (and 2 more...)
|
24 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT03019666 |
2015LS057
MT2015-46 |
|
October 18, 2017 |
April 30, 2018 |
March 31, 2019 |
January 12, 2017 |
December 5, 2017 |
|
- Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States
|
| 28 |
NCT03110432 |
Recruiting |
Prospective German Very High Cardiovascular Risk Patients Dyslipidemia Treatment Indication Registry |
|
- Drug: PCSK9 Inhibitor [EPC]
- Drug: Standard lipid lowering therapy
|
Observational |
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- LDL cholesterol goal achievement
- LDL cholesterol reduction
- Number of treatment changes
|
2000 |
All |
18 Years to 100 Years (Adult, Senior) |
NCT03110432 |
PERI-DYS |
PERI-DYS |
May 18, 2017 |
December 30, 2020 |
February 16, 2021 |
April 12, 2017 |
August 3, 2017 |
|
- Medizinische Klinik und Poliklinik III
Dresden, Germany
|
| 29 |
NCT03313297 |
Not yet recruiting |
Glucocorticoids and Skin Healing in Diabetes (GC-SHealD) |
- Diabetes Mellitus, Type 2
|
- Drug: AZD4017
- Drug: Placebo
|
Interventional |
Phase 2 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Skin 11β-HSD1 activity
- Urinary cortisol / cortisone metabolites
- AZD4017 in plasma
- (and 12 more...)
|
30 |
All |
18 Years and older (Adult, Senior) |
NCT03313297 |
ED17/93260 |
GC-SHealD |
December 1, 2017 |
June 1, 2018 |
June 30, 2018 |
October 18, 2017 |
October 18, 2017 |
|
|
| 30 |
NCT03360435 |
Recruiting |
Absorption of Transdermal Vitamins in Post Bariatric Surgery Patients |
- Bariatric Surgery Candidate
- Vitamin Deficiency
- Mineral Deficiency
|
- Dietary Supplement: Patch MD MultiVitamin Plus patch
|
Observational |
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Percentage of subjects with deficiencies
- Thiamine
- Pyridoxine
- (and 15 more...)
|
100 |
All |
18 Years and older (Adult, Senior) |
NCT03360435 |
IRB201701809 |
|
December 15, 2017 |
November 18, 2019 |
November 18, 2019 |
December 4, 2017 |
January 16, 2018 |
|
- University of Florida
Gainesville, Florida, United States
|
| 31 |
NCT02537392 |
Recruiting |
Multi-micronutrient Supplementation During Peri-conception and Congenital Heart Disease |
|
- Dietary Supplement: Vitamin B Complex and Folic Acid
- Dietary Supplement: Iron and Folic Acid
- Dietary Supplement: Folic Acid
|
Interventional |
Not Applicable |
- Health Science Center of Xi’an Jiaotong University
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Neonatal pulse oximetry oxygen saturation measured by pulse oximetry
- Incidence of congenital heart disease and the subtypes
- Incidence of birth defects and the subtypes
- (and 9 more...)
|
9374 |
Female |
15 Years to 49 Years (Child, Adult) |
NCT02537392 |
NSFC81230016 |
|
September 2015 |
December 2018 |
June 2019 |
September 1, 2015 |
January 13, 2017 |
|
- Xi'an Jiaotong University College of Medicine
Xi'an, Shaanxi, China
|
| 32 |
NCT03412773 |
Recruiting |
Phase 3 Study of BGB-A317 Versus Sorafenib in Patients With Unresectable HCC |
- Hepatocellular Carcinoma (HCC)
|
- Drug: BGB-A317
- Drug: Sorafenib
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Overall Survival (OS)
- Safety Run-In Substudy[Japan only]: Percentage of patients with adverse events
- Safety Run-In Substudy[Japan only]: Percentage of patients with dose-limiting toxicities (DLT) [Determination of the pivotal Phase 3 dose of BGB-A317 in Japanese patients]
- (and 25 more...)
|
660 |
All |
18 Years and older (Adult, Senior) |
NCT03412773 |
BGB-A317-301 |
|
December 28, 2017 |
January 2022 |
May 2022 |
January 26, 2018 |
January 30, 2018 |
|
- Precision Cancer Research / Dayton Physicians Network
Kettering, Ohio, United States
|
| 33 |
NCT03236649 |
Not yet recruiting |
The Phase III Study of Icaritin Versus Sorafenib in PD-L1 Positive Advanced Hepatocellular Carcinoma Subjects |
- Hepatocellular Carcinoma (HCC)
|
- Drug: Icaritin
- Drug: Sorafenib Tosylate Tablets
|
Interventional |
Phase 3 |
- Beijing Shenogen Biomedical Co., Ltd
- Chinese Academy of Medical Sciences
- NanJing PLA 81 Hospital
- (and 27 more...)
|
Industry / Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Overall survival (OS)
- Progression-free survival (PFS)
- Time to progress（TTP）
- (and 4 more...)
|
200 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT03236649 |
SNG1705ICR-2 |
|
August 30, 2017 |
August 2019 |
August 2019 |
August 2, 2017 |
August 2, 2017 |
|
|
| 34 |
NCT03212625 |
Recruiting |
The Effect of Urea Cream on Sorafenib-associated Hand-Foot Skin Reaction |
|
- Drug: Urea Cream 20%
- Drug: Placebos
|
Interventional |
Phase 4 |
- Korea University Guro Hospital
- Hanmi Pharmaceutical Company Limited
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Hand-Foot Skin Reaction(HFSR) prevalence rate on each group
- Event free survival of HFSR
- Severe HFSR prevalence rate
- (and 5 more...)
|
288 |
All |
Child, Adult, Senior |
NCT03212625 |
KUGH15337 |
|
January 28, 2016 |
January 31, 2019 |
January 31, 2019 |
July 11, 2017 |
March 7, 2018 |
|
- Korea University Guro Hospital
Seoul, Korea, Republic of
|
| 35 |
NCT03178656 |
Recruiting |
A Trial to Compare Surgery With Sorafenib for Hepatic Celluler Cancer With Portal Vein Tumor Thrombosis |
- Portal Vein Tumor Thrombus
|
- Drug: Sorafenib
- Procedure: surgery
|
Interventional |
Phase 4 |
- Huazhong University of Science and Technology
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Outcomes Assessor)
- Primary Purpose: Prevention
|
- overall survival of 1 year
- overall survival of 3 year
- time to progression
|
54 |
All |
20 Years to 75 Years (Adult, Senior) |
NCT03178656 |
chenxp007 |
|
December 15, 2016 |
April 15, 2018 |
December 15, 2019 |
June 7, 2017 |
December 21, 2017 |
|
- Hepatic surgery center, Tong ji Hospital
Wuhan, Hubei, China
|
| 36 |
NCT03140332 |
Recruiting |
Contribution of the Perfusion Scanner in the Prediction of the Tumor Control of Patients With Hepatocellular Carcinoma Treated With Sorafenib. |
- Hepatocellular Carcinoma
- Perfusion Scanner
|
- Other: Scannographic evaluation of the tumor response performed with mRECIST criteria after 3 months of treatment with sorafenib
|
Interventional |
Not Applicable |
- Centre Hospitalier Universitaire, Amiens
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- Scannographic evaluation of tumor response with mRECIST criteria
|
75 |
All |
18 Years and older (Adult, Senior) |
NCT03140332 |
PI2016_843_0025 |
HCC-CTPerf |
October 21, 2016 |
October 21, 2019 |
October 21, 2019 |
May 4, 2017 |
May 4, 2017 |
|
- CHU Amiens Picardie
Amiens, Picardie, France
|
| 37 |
NCT03097848 |
Recruiting |
Efficacy and Safety of Sorafenib as Adjuvant and Latter Radiofrequency Ablation for Recurrent Hepatocellular Carcinoma |
|
- Procedure: RFA
- Drug: Sorafenib
|
Interventional |
Not Applicable |
- Southwest Hospital, China
- Chengdu PLA General Hospital
- Sichuan Provincial People's Hospital
- (and 11 more...)
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Disease free survival
- Time To Recurrence
- Overall Survival
- (and 3 more...)
|
450 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT03097848 |
SWHB 019 |
ESCALATOR |
May 4, 2017 |
December 30, 2018 |
December 31, 2018 |
March 31, 2017 |
May 8, 2017 |
|
- Southwest Hospital
Chongqing, Chongqing, China
|
| 38 |
NCT02988440 |
Recruiting |
Study of Safety and Tolerability of PDR001 in Combination With Sorafenib and to Identify the Maximum Tolerated Dose and/or Phase 2 Dose for This Combination in Advanced Hepatocellular Patients |
|
- Drug: PDR001
- Drug: Sorafenib
|
Interventional |
Phase 1 |
- Novartis Pharmaceuticals
- Novartis
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of participants with Adverse Events (AEs) as a measure of safety and tolerability
- Pharmacokinetics (PK): Ctrough
- Pharmacokinetics (PK): Cmax
- (and 9 more...)
|
50 |
All |
18 Years and older (Adult, Senior) |
NCT02988440 |
CPDR001G2101
2016-004131-20 |
|
April 20, 2017 |
December 30, 2018 |
July 18, 2019 |
December 9, 2016 |
November 17, 2017 |
|
- Karmanos Cancer Institute
Detroit, Michigan, United States - Novartis Investigative Site
Montreal, Quebec, Canada - Novartis Investigative Site
Clichy, France - (and 5 more...)
|
| 39 |
NCT02867280 |
Recruiting |
Sorafenib Treatment in Patients With Hepatocellular Carcinoma With Microvascular Invasion After Radical Resection |
- Hepatocellular Carcinoma
- Recurrence
|
|
Interventional |
Phase 3 |
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Recurrence free survival
- Time To Recurrence
- Recurrence rate
- (and 3 more...)
|
400 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT02867280 |
Sorafenib-MVI |
|
June 2016 |
June 2023 |
June 2023 |
August 15, 2016 |
August 15, 2016 |
|
- Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
|
| 40 |
NCT02856126 |
Recruiting |
HAIC Plus Sorafenib Versus TACE Plus Sorafenibfor Advanced HCC |
|
- Procedure: Hepatic arterial infusion chemotherapy
- Procedure: Transarterial chemoembolization
- Drug: TACE regimen
- (and 2 more...)
|
Interventional |
Phase 3 |
- Sun Yat-sen University
- Kaiping Central Hospital
- First Affiliated Hospital, Sun Yat-Sen University
- (and 4 more...)
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Overall survival
- Progress free survival
- Adverse Events
- Number of of Patients developed Adverse Events
|
214 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT02856126 |
HCC-S022 |
|
August 2016 |
August 2018 |
August 2018 |
August 4, 2016 |
November 17, 2017 |
|
- Dongguan People's Hospital
Dongguan, Guangdong, China - Cancer Center Sun Yat-sen University
Guangzhou, Guangdong, China - The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China - (and 4 more...)
|
| 41 |
NCT02834546 |
Recruiting |
Correlation Between Sorafenib Plasma Concentrations, Toxicity and Disease Control Rate in Patients Treated by Sorafenib for Hepatocellular Carcinoma |
- Hepatocellular Carcinoma (HCC)
|
- Biological: Sorafenib plasma concentration 4 weeks after treatment initiation
|
Observational |
|
- University Hospital, Bordeaux
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Adverse events related to Sorafenib needing a dose adjustment or a symptomatic medication
- Adverse events notification
- Radiological response assessed by scan or MRI
- (and 2 more...)
|
100 |
All |
18 Years and older (Adult, Senior) |
NCT02834546 |
CHUBX 2014/25 |
ACTES |
July 25, 2017 |
November 2018 |
October 2019 |
July 15, 2016 |
November 13, 2017 |
|
- Institut Bergonié
Bordeaux, France - CHU de Limoges
Limoges, France - CHU de Montpellier
Montpellier, France - (and 2 more...)
|
| 42 |
NCT02794337 |
Recruiting |
TACE vs TACE+SBRT for Unresectable Hepatocellular Cancer |
- Carcinoma, Hepatocellular
|
- Radiation: SBRT
- Procedure: TACE
- Drug: Sorafenib
|
Interventional |
Phase 2
Phase 3 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- In-field Progression Free Survival
- Cause Specific Survival
- Response assessment after treatment
- (and 2 more...)
|
386 |
All |
18 Years and older (Adult, Senior) |
NCT02794337 |
TMC IEC III 91 |
TACE-SBRT |
December 2014 |
January 2019 |
January 2022 |
June 9, 2016 |
June 9, 2016 |
|
- Advanced Centre for Treatment, Research and Education in Cancer, Tata Memorial Centre
Navi Mumbai, Maharashtra, India - Advanced Centre of Treatment Research and Education In Cancer,Tata Memorial Centre
Navi Mumbai, Maharashtra, India
|
| 43 |
NCT02733809 |
Recruiting |
Mechanism of Sorafenib Resistance in Patients With Advanced Hepatocellular Carcinoma |
|
|
Interventional |
Phase 4 |
- King Saud University
- King Faisal Specialist Hospital & Research Center
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Overall and disease-free survival genes.
- The predictors of survival ( response to Sorafenib )
- Potential genetic targets for resistance.
|
40 |
All |
18 Years and older (Adult, Senior) |
NCT02733809 |
KSULDRCSSMH001 |
|
January 2014 |
December 2024 |
December 2024 |
April 12, 2016 |
August 22, 2017 |
|
- King Saud University Medical City
Riyadh, Saudi Arabia
|
| 44 |
NCT02645981 |
Recruiting |
Efficacy and Safety of Donafenib in Patients With Advanced Hepatocellular Carcinoma |
|
- Drug: Donafenib
- Drug: Sorafenib
|
Interventional |
Phase 2
Phase 3 |
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
- Tigermed Consulting Co., Ltd
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Overall Survival
- Progress Free Survival
- Percentage of adverse events
|
660 |
All |
18 Years and older (Adult, Senior) |
NCT02645981 |
ZGDH3 |
|
March 2016 |
February 2019 |
August 2019 |
January 5, 2016 |
March 24, 2017 |
|
- The PLA 81 Hospital
Nanjing, Jiangsu, China - West China Hospital Sichuan University
Chengdu, Sichuan, China
|
| 45 |
NCT02642913 |
Recruiting |
Study of Enzalutamide With and Without Sorafenib in Advanced Hepatocellular Carcinoma Patients |
|
- Drug: Enzalutamide
- Drug: Enzalutamide with Sorafenib
|
Interventional |
Phase 1
Phase 2 |
- Memorial Sloan Kettering Cancer Center
- Astellas Pharma US, Inc.
- Mayo Clinic
- (and 6 more...)
|
Other / Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Progression-free survival
|
73 |
All |
18 Years and older (Adult, Senior) |
NCT02642913 |
15-279 |
|
December 2015 |
December 2018 |
December 2018 |
December 30, 2015 |
October 12, 2017 |
|
- University of California San Francisco
San Francisco, California, United States - Washington University School of Medicine
Saint Louis, Missouri, United States - Roswell Park Cancer Institute
Buffalo, New York, United States - (and 2 more...)
|
| 46 |
NCT02636426 |
Recruiting |
Sorafenib Administered Using a High-dose, Pulsatile Regimen: a Phase I Exposure Escalation Study |
|
|
Interventional |
Phase 1 |
- VU University Medical Center
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- To determine the maximum tolerated plasma AUC0-12h of high-dose, pulsatile sorafenib
- AUC0-12h of sorafenib and its primary active metabolite pyridine-N-oxide (escalation cohorts)
- Cmax of sorafenib and its primary active metabolite pyridine-N-oxide (escalation cohorts)
- (and 6 more...)
|
40 |
All |
18 Years and older (Adult, Senior) |
NCT02636426 |
2015.224 |
SOPRANO |
September 2015 |
December 2017 |
December 2017 |
December 21, 2015 |
March 20, 2017 |
|
- VU University Medical Center
Amsterdam, Noord-Holland, Netherlands
|
| 47 |
NCT02575339 |
Recruiting |
MLN0128 Compared to Sorafenib in Advanced or Metastatic Hepatocellular Carcinoma |
- Hepatocellular Carcinoma
- Liver Cancer
- HCC
|
- Drug: MLN0128
- Drug: MLN0128 (RP2D)
- Drug: Sorafenib
|
Interventional |
Phase 1
Phase 2 |
- Bert O'Neil, MD
- Millennium Pharmaceuticals, Inc.
- Big Ten Cancer Research Consortium
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Phase I: Maximum Tolerated Dose (MTD) of MLN0128
- Phase II: Time to Progression (TTP)
- Phase I: Characterize Adverse Effects (AE)
- (and 9 more...)
|
118 |
All |
18 Years and older (Adult, Senior) |
NCT02575339 |
BTCRC GI13-002 |
|
July 2016 |
December 2018 |
June 2020 |
October 14, 2015 |
January 9, 2018 |
|
- Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States - University of Illinois Cancer Center
Chicago, Illinois, United States - Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States - (and 3 more...)
|
| 48 |
NCT02562755 |
Recruiting |
Hepatocellular Carcinoma Study Comparing Vaccinia Virus Based Immunotherapy Plus Sorafenib vs Sorafenib Alone |
- Hepatocellular Carcinoma (HCC)
|
- Biological: Pexastimogene Devacirepvec (Pexa Vec)
- Drug: Sorafenib
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Overall Survival
- Time to Progression (TTP)
- Progression Free Survival (PFS)
- (and 4 more...)
|
600 |
All |
18 Years and older (Adult, Senior) |
NCT02562755 |
JX594-HEP024 |
PHOCUS |
October 2015 |
October 2018 |
October 2019 |
September 29, 2015 |
March 14, 2018 |
|
- University of Alabama
Birmingham, Alabama, United States - Mayo Clinic Arizona
Scottsdale, Arizona, United States - UC Irvine Medical Center
Orange, California, United States - (and 103 more...)
|
| 49 |
NCT02537158 |
Recruiting |
Sorafenib and TACE as Adjuvant Therapy for MVI in HCC Patients After Radical Resection |
|
- Drug: Sorafenib
- Procedure: TACE
|
Interventional |
Not Applicable |
- Chinese Academy of Medical Sciences
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- recurrence-free survival
- overall survival
|
90 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT02537158 |
CH-GI-077 |
|
August 2015 |
July 2018 |
July 2018 |
September 1, 2015 |
March 15, 2016 |
|
- Cancer Hospital and Institute, Chinese Academy of Medical Sciences
Bei jing, China
|
| 50 |
NCT02530476 |
Recruiting |
Phase I/II, Study of Selective Inhibitor of Nuclear Export (SINE) Selinexor (KPT-330) + Sorafenib in Acute Myeloid Leukemia |
- Leukemia
- Acute Myeloid Leukemia
|
- Drug: Selinexor
- Drug: Sorafenib
|
Interventional |
Phase 1
Phase 2 |
- M.D. Anderson Cancer Center
- Karyopharm Therapeutics Inc
- National Cancer Institute (NCI)
|
Other / Industry / NIH |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Maximum Tolerated Dose (MTD) of Selinexor with Sorafenib
- Composite CR (CRc) Rate defined as CR (complete remission) + CRp (complete remission with incomplete platelet recovery) + CRi (complete remission with incomplete count recovery) within 3 months of treatment initiation
|
52 |
All |
18 Years and older (Adult, Senior) |
NCT02530476 |
2014-0975
NCI-2015-01523
P50CA100632 |
|
December 8, 2015 |
December 2019 |
December 2020 |
August 21, 2015 |
April 17, 2018 |
|
- University of Texas MD Anderson Cancer Center
Houston, Texas, United States
|
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