Clinical trials: Phase I
Solid Tumors, ER/PR Positive Breast Cancer
MM-398 (Nanoliposomal Irinotecan, Nal-IRI) to Determine Tumor Drug Levels and to Evaluate the Feasibility of Ferumoxytol Magnetic Resonance Imaging to Measure Tumor Associated Macrophages and to Predict Patient Response to Treatment
This is a Phase I study to understand the biodistribution of MM-398 and to determine the feasibility of using Ferumoxytol as a tumor imaging agent.
- Conditions
- Solid Tumors, ER/PR Positive Breast Cancer, Triple Negative Breast Cancer, Metastatic Breast Cancer With Active Brain Metastasis
- Trial name
- NCT01770353
- Testing
- Ferumoxytol, MM-398
- Where
- 7 sites in United States
- Volunteers
- 45 people
- Sponsor
- Ipsen
Antibody-mediated Rejection, Kidney Transplant; Complications
Clazakizumab for Chronic and Active Antibody Mediated Rejection Post-Kidney Transplant
Antibody mediated rejection (ABMR) is a unique, significant and often severe form of allograft rejection. This single center, phase I/II, open label single-arm exploratory study focuses on enrolling ten patients with biopsy…
- Conditions
- Antibody-mediated Rejection, Kidney Transplant; Complications, Transplant Glomerulopathy, Transplant Glomerulopathy - Late Form
- Trial name
- NCT03380377
- Testing
- Clazakizumab
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Stanley Jordan, MD
Prevention From Norovirus Infection
Norovirus Bivalent-Vaccine Efficacy Study
The purpose of this study is to determine whether the norovirus vaccine is effective in preventing acute gastroenteritis due to the experimental human Norovirus GII.4 challenge dose.
- Trial name
- NCT01609257
- Testing
- Norovirus Bivalent Vaccine, Saline Comparator
- Where
- 5 sites in United States
- Volunteers
- 132 people, healthy volunteers welcome
- Sponsor
- Takeda
Alcohol-Related Disorders, Substance-Related Disorders
The Women's Recovery Group Study: Stage I Trial
The purpose of this study was to develop a gender-specific 12-session, manual-based relapse prevention group for women with substance use disorders (SUDs).
- Trial name
- NCT00230100
- Testing
- The Women's Recovery Group, mixed-gender Group Drug Counseling
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- Mclean Hospital
Postmenopausal Women With Osteoporosis
Study Investigating PK, PD, Efficacy, Safety, and Immunogenicity of Biosimilar Denosumab (GP2411) in Patients With Postmenopausal Osteoporosis
This study was conducted to assess if there were any clinically meaningful differences in pharmacokinetics (PK), pharmacodynamics (PD), efficacy, safety, or immunogenicity between GP2411 (proposed biosimilar denosumab) and…
- Trial name
- NCT03974100
- Testing
- GP2411, EU-Prolia (EU-authorized Prolia®)
- Where
- 42 sites in United States, Bulgaria and 4 more
- Volunteers
- 527 people
- Sponsor
- Sandoz
Healthy Volunteers
A Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability of TAK-788 Followed by Evaluation of the Effects of a Low-Fat Meal on TAK-788 PK and Evaluation of Relative Bioavailability of TAK-788 Capsules in Healthy Participants
The purpose of this study is to assess the safety, tolerability of TAK-788 and to identify a tolerable single oral dose of TAK-788 administered as a drug-in-capsule (DiC) formulation, to characterize the effects of a low-fat meal…
- Trial name
- NCT03482453
- Testing
- TAK-788
- Where
- United States
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- Millennium Pharmaceuticals, Inc.
HIV Infections
Evaluating the Safety, Tolerability, and Effect of a Human Monoclonal Antibody (VRC01) on Markers of HIV Persistence in HIV-Infected Adults Receiving Antiretroviral Therapy (ART)
The purpose of this study was to evaluate the safety, tolerability, and effect of an experimental human monoclonal antibody (mAb), VRC-HIVMAB060-00-AB (VRC01), in adults infected with HIV who were receiving antiretroviral therapy…
- Trial name
- NCT02411539
- Testing
- VRC01
- Where
- 13 sites in United States
- Volunteers
- 40 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Breast Cancer
Letrozole in Preventing Breast Cancer in Postmenopausal Women
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Letrozole may be effective in preventing the development or recurrence of breast cancer in postmenopausal…
- Trial name
- WISE (NCT00090857)
- Testing
- Letrozole
- Where
- 5 sites in United States
- Volunteers
- 49 people
- Sponsor
- Dana-Farber Cancer Institute
Osteoarthritis of the Knee
A Study to Evaluate Safety of Three Intra-articular Injections of Ampion in the Knee of Adults With Osteoarthritis Pain
Phase 1 will evaluate the safety of 3 intra-articular injections of Ampion™ administered 2 weeks apart to adults with osteoarthritis of the knee.
- Trial name
- NCT02184156
- Testing
- 4 mL injection of Ampion
- Where
- United States
- Volunteers
- 47 people
- Sponsor
- Ampio Pharmaceuticals. Inc.
Malignant Melanoma, Squamous Cell Carcinoma of Skin
A Study of SAR444245 Combined With Cemiplimab for the Treatment of Participants With Various Advanced Skin Cancers (Pegathor Skin 201)
Primary Objective: -To determine the antitumor activity of SAR444245 in combination with cemiplimab. Secondary Objectives: To determine the recommended phase 2 dose and to assess the safety profile of SAR444245 when combined with…
- Trial name
- NCT04913220
- Testing
- THOR-707, Cemiplimab
- Where
- 24 sites in United States, Australia and 5 more
- Volunteers
- 46 people
- Sponsor
- Sanofi
Systemic Infections
Safety and Tolerability of Ceftazidime-Avibactam for Pediatric Patients With Suspected or Confirmed Infections
To assess the pharmacokinetics, safety and tolerability of a single dose of CAZ-AVI in children from 3 months of age to <18 years.
- Trial name
- NCT01893346
- Testing
- CAZ-AVI
- Where
- 10 sites in United States
- Volunteers
- 35 people
- Sponsor
- Pfizer
Ischemia, Retinal Vein Occlusion
Study of 2.0 mg Ranibizumab in Subjects With Ischemic Central Retinal Vein Occlusion (RAVE2)
The RAVE 2 trial is a phase I, open label, 12-month trial of intravitreal ranibizumab 2.0 mg in patients with ischemic CRVO who have been either previously treated with ranibizumab or treatment naïve.
- Conditions
- Ischemia, Retinal Vein Occlusion, Pathologic Processes, Retinal Diseases
- Trial name
- RAVE2 (NCT01225146)
- Testing
- ranibizumab
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- David M. Brown, M.D.
Mantle-Cell Lymphoma
A Study of Ixazomib and Ibrutinib in Relapsed/Refractory Mantle Cell Lymphoma
Patients with mantle cell lymphoma (MCL) that has relapsed (come back) or refractory (progressed on treatment) will receive ixazomib and ibrutinib.
- Trial name
- PrE0404 (NCT03323151)
- Testing
- Ixazomib, Ibrutinib
- Where
- 14 sites in United States
- Volunteers
- 43 people
- Sponsor
- PrECOG, LLC.
Pancreatic Cancer, Metastatic Castration-resistant Prostate Cancer
Study of NGM120 in Subjects With Advanced Solid Tumors, Pancreatic Cancer, and Prostate Cancer Using Combination Therapy
Study of NGM120 in subjects with advanced solid tumors and pancreatic cancer (Part 1 and 2) and metastatic castration resistant prostate cancer (Part 3).
- Conditions
- Pancreatic Cancer, Metastatic Castration-resistant Prostate Cancer, Bladder Cancer, Melanoma
- Trial name
- NCT04068896
- Testing
- NGM120 30mg, NGM120 100mg, NGM120 30mg with Gemcitabine and Abraxane
- Where
- 20 sites in United States
- Volunteers
- 89 people
- Sponsor
- NGM Biopharmaceuticals, Inc
Moderate to Severe Asthma
Phase I Assessment of Hypertonic Saline in Moderate to Severe Asthmatics
Purpose: To determine if inhaled hypertonic saline (HS) accelerates airway mucociliary clearance (MCC) in well-controlled moderate to severe asthmatics.
- Trial name
- NCT03556683
- Testing
- 3% Hypertonic Saline, 7% Hypertonic Saline, Salbutamol
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- University of North Carolina, Chapel Hill
Melanoma, Non-small Sell Lung Cancer (NSCLC)
Phase I/II Study of PDR001 in Patients With Advanced Malignancies
The purpose of this "first-in-human" study of PDR001 was to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of PDR001 administered i.v.
- Conditions
- Melanoma, Non-small Sell Lung Cancer (NSCLC), Triple Negative Breast Cancer, Anaplastic Thyroid Cancer
- Trial name
- NCT02404441
- Testing
- PDR001
- Where
- 41 sites in United States, Canada and 12 more
- Volunteers
- 319 people
- Sponsor
- Novartis Pharmaceuticals
Healthy Participants
A Study to Learn About the Study Medicine PF-07853578 and How it Acts in the Bodies of Healthy Adults
The purposes of this study are: To see how the new medicine (PF-07853578) under study is tolerated. And if there are any important side effects. And, how people feel after taking single increasing amount of the medicine by mouth.
- Trial name
- NCT05890105
- Testing
- PF-07853578
- Where
- 2 sites in United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Pfizer
Clinical Stage IV Cutaneous Melanoma AJCC v8, Metastatic Melanoma
Testing the Addition of the Anti-cancer Drug, Tazemetostat, to the Usual Treatment (Dabrafenib and Trametinib) for Metastatic Melanoma That Has Progressed on the Usual Treatment
This phase I/II trial investigates the best dose, possible benefits and/or side effects of tazemetostat in combination with dabrafenib and trametinib in treating patients with melanoma that has a specific mutation in the BRAF…
- Trial name
- NCT04557956
- Testing
- Biopsy Procedure, Computed Tomography, Dabrafenib Mesylate
- Where
- 17 sites in United States
- Volunteers
- 16 people
- Sponsor
- National Cancer Institute (NCI)
Drug-induced QT Prolongation, Pharmacokinetics
CiPA Phase 1 ECG Biomarker Validation Study
This study will assess whether exposure response analysis of the electrocardiographic QTc and J-Tpeakc intervals in Phase 1 clinical pharmacology studies can be used to confirm that drugs that predominantly block the potassium…
- Conditions
- Drug-induced QT Prolongation, Pharmacokinetics, Pharmacodynamics
- Trial name
- NCT03070470
- Testing
- Ranolazine, Verapamil, Lopinavir / Ritonavir
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Food and Drug Administration (FDA)
Diabetes Mellitus, Type 2
A Single-dose Phase 1 Study of DBPR108 in Healthy Male Subjects
The study is being performed to assess the safety, tolerability, and pharmacokinetic (PK) and pharmacodynamic (PD) properties of single oral doses of DBPR108 in healthy male subjects.
- Trial name
- NCT01650324
- Testing
- DBPR108
- Where
- Taiwan
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- National Health Research Institutes, Taiwan
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