Clinical trials: Phase I
B-cell Chronic Lymphocytic Leukemia, Refractory Chronic Lymphocytic Leukemia
Imprime PGG, Alemtuzumab, and Rituximab in Treating Patients With High Risk Chronic Lymphocytic Leukemia
RATIONALE: Monoclonal antibodies, such as alemtuzumab and rituximab, can kill chronic lymphocytic leukemia (CLL) cells and are effective therapies for this disease.
- Conditions
- B-cell Chronic Lymphocytic Leukemia, Refractory Chronic Lymphocytic Leukemia, Stage 0 Chronic Lymphocytic Leukemia, Stage I Chronic Lymphocytic Leukemia
- Trial name
- NCT01269385
- Testing
- alemtuzumab, rituximab, PGG beta-glucan
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Mayo Clinic
Duchenne Muscular Dystrophy
DART Electrical Impedance Myography (EIM) Trial in Duchenne Muscular Dystrophy (DMD) and Healthy Controls
Physicians seek a method to assess neuromuscular disease that is both non-invasive and quantifiable. Many patients do not tolerate standard current day assessment tools (such as needle electromyogram), and Electrical Impedance…
- Trial name
- NCT01523964
- Testing
- Testing with EIM
- Where
- 6 sites in United States
- Volunteers
- 92 people, healthy volunteers welcome
- Sponsor
- Dart Therapeutics. LLC
Crohn's Disease
A Phase 1/2 Study of Repeated Intravenous E6011 Administration in Japanese Subjects With Crohn's Disease
This study is a multicenter, open-label, uncontrolled, multiple ascending dose (MAD) study to evaluate mainly the safety and tolerability of 12-week repeated intravenous administration of E6011.
- Trial name
- NCT02039063
- Testing
- E6011 2 mg/kg, E6011 5 mg/kg, E6011 10 mg/kg
- Where
- 17 sites in Japan
- Volunteers
- 28 people
- Sponsor
- EA Pharma Co., Ltd.
Inflammatory Disease
Pharmacokinetics of Lanraplenib in Adults With Impaired Renal Function
The primary objective of this study is to evaluate the pharmacokinetics (PK) of lanraplenib in participants with impaired renal function relative to matched healthy controls.
- Trial name
- NCT02959138
- Testing
- Lanraplenib.
- Where
- 6 sites in United States, Germany and 1 more
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Mantle Cell Lymphoma (MCL)
A Study of Copanlisib and Ibrutinib in Mantle Cell Lymphoma
The purpose of this study is to test the safety and any good and bad side effects of combining 2 study drugs, copanlisib and ibrutinib.
- Trial name
- NCT03877055
- Testing
- Copanlisib, Ibrutinib
- Where
- 6 sites in United States
- Volunteers
- 8 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Advanced or Metastatic Solid Tumors
A Study of MK-6598 as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Advanced Solid Tumors (MK-6598-001)
The purpose of this study is to assess the efficacy and safety and establish a preliminary recommended Phase 2 dose (RP2D) of MK-6598 administered as monotherapy and in combination with pembrolizumab (MK-3475) in adult…
- Trial name
- NCT05594043
- Testing
- MK-6598, Pembrolizumab
- Where
- 6 sites in United States, Canada and 1 more
- Volunteers
- 39 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis B, Chronic
Safety, Efficacy, Immunogenicity Study of GSK Biologicals' HBV Viral Vector and Adjuvanted Proteins Vaccine (GSK3528869A) in Adult Patients With Chronic Hepatitis B Infection
A First-Time-In-Human study on GSK's therapeutic vaccines to evaluate the reactogenicity, safety, immunogenicity and efficacy on reduction of serum HBV surface antigen in HBV suppressed participants under nucleo(s)tide treatment.
- Trial name
- NCT03866187
- Testing
- ChAd155-hIi-HBV low dose formulation, ChAd155-hIi-HBV high dose formulation, HBc-HBs/AS01B-4 low dose formulation
- Where
- 43 sites in Belgium, France and 7 more
- Volunteers
- 236 people
- Sponsor
- GlaxoSmithKline
Hepatic Impairment
Tepotinib Hepatic Impairment Trial
The study investigated the effect of various degrees of hepatic impairment on the pharmacokinetics (PK), safety and tolerability of tepotinib.
- Trial name
- NCT03546608
- Testing
- Tepotinib
- Where
- 2 sites in United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Overweight, Obese
iStart Smart for Teens for Healthy Weight Management
The emerging epidemic of type 2 diabetes mellitus (T2DM) in children is coupled with the increased prevalence of childhood obesity in the last two decades.
- Trial name
- NCT01693250
- Testing
- fitbit Ultra, Pedometer
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Prostate Cancer
Phase 1 Trial of PAN-301-1 (SNS-301) in Cancer Patients
This is a Phase I, open-label, parallel design study of PAN-301-1 (SNS-301), a HAAH directed nanoparticle vaccine, given intradermally in cohorts of patients with biochemically relapsed prostate cancer, using a fixed dose…
- Trial name
- NCT03120832
- Testing
- PAN-301-1
- Where
- 4 sites in United States
- Volunteers
- 12 people
- Sponsor
- Sensei Biotherapeutics, Inc.
Parkinson's Disease
Phase I Deep Brain Stimulation (DBS) vs. Best Medical Therapy (BMT) Trial
The goals of this study are to determine if simultaneous bilateral subthalamic nucleus stimulation or simultaneous bilateral globus pallidus stimulation is more effective in reducing symptoms of Parkinson's disease, and if deep…
- Trial name
- NCT00056563
- Testing
- Bilateral Deep Brain Stimulation, best medical therapy
- Where
- 14 sites in United States
- Volunteers
- 255 people
- Sponsor
- US Department of Veterans Affairs
Healthy Adult Subjects
Comparative Bioavailability Study of Oral Edaravone Administered Orally and Via a Nasogastric Tube
To investigate the comparative bioavailability of edaravone oral suspension administered orally and via a nasogastric tube in healthy adult subjects
- Trial name
- NCT04776135
- Testing
- MT-1186
- Where
- Japan
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Shionogi
Pancreatic Cancer, Adult
QUILT-3.010: A Study of Gemcitabine and Nab-paclitaxel With or Without NPC-1C to Treat Patients With Pancreatic Cancer
This was a Phase 1/2 multi-institution prospective open label study in which subjects with metastatic, locally advanced unresectable or recurrent pancreatic cancer who previously received treatment with chemotherapy with…
- Trial name
- NCT01834235
- Testing
- Gemcitabine, nab-paclitaxel, NPC-1C
- Where
- 12 sites in United States
- Volunteers
- 81 people
- Sponsor
- Precision Biologics, Inc
Opioid Dependence
INDV-2000 First in Human
This study is a single ascending dose (SAD) study conducted to identify the maximum tolerated dose (MTD) of INDV-2000. After completion of the SAD portion of the study and acceptable safety evaluation, a food-interaction…
- Trial name
- NCT04413552
- Testing
- INDV-2000
- Where
- United States
- Volunteers
- 73 people, healthy volunteers welcome
- Sponsor
- Indivior Inc.
High Grade Glioma, Ependymoma
HUMC 1612: Optune NovoTTF-200A System
The purpose of this study is to determine if the Optune NovoTTF-200A device can be safely used in combination with chemotherapy in pediatric patients with recurrent high-grade glioma and ependemoma.
- Trial name
- NCT03128047
- Testing
- Optune NovoTTF-200A System
- Where
- 2 sites in United States
- Volunteers
- 7 people
- Sponsor
- Hackensack Meridian Health
Metastatic Pancreatic Adenocarcinoma
LEE011 Plus Everolimus in Patients With Metastatic Pancreatic Adenocarcinoma Refractory to Chemotherapy
This study is a single-arm, open-label, multi-institutional Phase I/II trial of the combination of LEE011 and everolimus in refractory mPAC.
- Trial name
- NCT02985125
- Testing
- LEE011, Everolimus
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Georgetown University
Helicobacter Pylori Infection
A Phase 1 Study to Evaluate PK Profile of Multiple Oral Administrations of TNP-2092 Capsules in Healthy Subjects
This study was a single-center, randomized, double-blind, placebo-controlled, dose-ascending multiple-dose-administration study.
- Trial name
- NCT06190340
- Testing
- TNP-2092 capsules
- Where
- China
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- TenNor Therapeutics (Suzhou) Limited
Breast Cancer
DWI in Assessing Treatment Response in Patients With Breast Cancer Receiving Neoadjuvant Chemotherapy
RATIONALE: Imaging procedures, such as diffusion-weighted magnetic resonance imaging (DWI) and dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI), may help in evaluating how well patients with breast cancer respond to…
- Trial name
- ACRIN6698 (NCT01564368)
- Testing
- diffusion-weighted magnetic resonance imaging
- Where
- 7 sites in United States
- Volunteers
- 406 people
- Sponsor
- American College of Radiology Imaging Network
Disease Caused by Severe Acute Respiratory Syndrome Coronavirus 2 (Disorder)
A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of Inhaled MBS-COV (SNS812) in Healthy Participants
A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of Inhaled MBS-COV in Healthy Participants
- Trial name
- NCT05677893
- Testing
- MBS-COV
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Oneness Biotech Co., Ltd.
Breast Neoplasms
A Study to Learn About the Vepdegestrant (ARV-471, PF-07850327) in People With ER+/HER2- Locally Advanced or Metastatic Breast Cancer (BC)
The purpose of this clinical trial is to learn about the safety, tolerability, Pharmacokinetics (PK), and preliminary efficacy of ARV-471 as monotherapy in Japanese participants with ER+/HER2- locally advanced or metastatic…
- Trial name
- NCT05463952
- Testing
- vepdegestrant
- Where
- 3 sites in Japan
- Volunteers
- 6 people
- Sponsor
- Pfizer
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