Clinical trials: Phase I
Acute Leukemias of Ambiguous Lineage, B-cell Adult Acute Lymphoblastic Leukemia
S1312, Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Leukemia
This phase I trial studies the side effects and best dose of inotuzumab ozogamicin when given together with combination chemotherapy in treating patients with relapsed or refractory acute leukemia.
- Conditions
- Acute Leukemias of Ambiguous Lineage, B-cell Adult Acute Lymphoblastic Leukemia, Philadelphia Chromosome Positive Adult Precursor Acute Lymphoblastic Leukemia, Recurrent Adult Acute Lymphoblastic Leukemia
- Trial name
- NCT01925131
- Testing
- cyclophosphamide, vincristine sulfate, prednisone
- Where
- 5 sites in United States
- Volunteers
- 50 people
- Sponsor
- SWOG Cancer Research Network
Stomach Neoplasms
Study Of Sunitinib In Combination With Cisplatin And 5-Fluorouracil In Patients With Advanced Gastric Cancer
The purpose of this study is to determine the safe and tolerable dose of sunitinib when given together with cisplatin and 5-fluorouracil in patients with advanced gastric cancer who have not received prior chemotherapy for their…
- Trial name
- NCT00555672
- Testing
- 5-fluorouracil, cisplatin, sunitinib malate
- Where
- 3 sites in Spain
- Volunteers
- 34 people
- Sponsor
- Pfizer
Healthy
A Study Comparing the Drug Exposure in Humans After Administration of a 50 mg Tablet of Sertraline Hydrochloride as Compared to a 50 mg Capsule of Sertraline Hydrochloride Under Fasted (Nonfed) Conditions
This study is designed to determine differences in drug exposure in subjects after being administered 50 mg tablets of sertraline hydrochloride as compared to drug exposure after administering 50 mg capsules of sertraline…
- Trial name
- NCT01235195
- Testing
- sertraline hydrochloride
- Where
- Singapore
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Cutaneous Melanoma, Stage III, Cutaneous Melanoma, Stage IV
pDNA Intralesional Cancer Vaccine for Cutaneous Melanoma
Six patients will receive IFx-Hu2.0 on an outpatient basis at a single time point in a single lesion, two lesions, or three lesions, as a monotherapy (a maximum of three lesions could be injected).
- Trial name
- NCT03655756
- Testing
- IFx-Hu2.0
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- TuHURA Biosciences, Inc.
Sarcoidosis
Trial of Antimycobacterial Therapy in Sarcoidosis
Growing research from independent laboratories provide an association between mycobacteria and sarcoidosis. More recent immunologic and molecular studies demonstrate immune responses to mycobacteria virulence factors.
- Trial name
- CLEAR (NCT01074554)
- Testing
- Antibiotic Regimen
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Vanderbilt University
Lymphedema, Breast Cancer
Arm Circumference Measurement With or Without Bioimpedance Spectroscopy in Finding Lymphedema Early in Patients With Stage I-III Breast Cancer
This randomized pilot clinical trial studies arm circumference measurement with or without bioimpedance spectroscopy in finding extra lymph node fluid build up in the arm (lymphedema) early in patients with stage I-III breast…
- Trial name
- NCT03648983
- Testing
- arm circumference measurement, Bioimpedance spectroscopy
- Where
- United States
- Volunteers
- 95 people
- Sponsor
- Albert Einstein College of Medicine
Recurrent Plasma Cell Myeloma, Refractory Plasma Cell Myeloma
Immunotherapy With BCMA CAR-T Cells in Treating Patients With BCMA Positive Relapsed or Refractory Multiple Myeloma
This phase I trial studies the side effects and best dose of BCMA CAR-T cells in treating patients with BCMA positive multiple myeloma that has come back or does not respond to treatment.
- Trial name
- NCT03338972
- Testing
- Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143, Cyclophosphamide, Fludarabine
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Fred Hutchinson Cancer Center
Inherited Ophthalmic Diseases, Inherited Retinal Degeneration
Interferon Gamma-1b Administered Topically for Macular Edema/Intraretinal Schisis Cysts in Rod-Cone Dystrophy (RCD) and Enhanced S-Cone Syndrome (ESCS)
Background: People with rod-cone dystrophy (RCD) or enhanced S-cone syndrome (ESCS) have excess fluid under the retina of their eye. This can cause vision loss.
- Trial name
- NCT02338973
- Testing
- Interferon gamma-1b
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- National Eye Institute (NEI)
Obesity
A Study to Evaluate the Effect of the Experimental GLP-1 Drug PF-07081532 on Blood Levels of Common Birth Control Pills, and Drugs Omeprazole and Midazolam, and Effect of GLP-1 Drug Semaglutide on Midazolam Blood Levels in Healthy Adults With Weight in the Obesity Range
Two different groups of healthy volunteers will be chronically treated with GLP-1 drugs PF-07081532 or alternatively Semaglutide.
- Trial name
- NCT05671653
- Testing
- PF-07081532, Semaglutide
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Pfizer
Myelofibrosis, Primary Myelofibrosis (PMF)
Study to Evaluate Safety, Pharmacokinetic and Pharmacodynamic Dose Escalation and Expansion Study of PXS-5505 in Patients With Primary, Post-polycythemia Vera or Post-essential Thrombocythemia Myelofibrosis
This study will be an open-label phase 1/2a study to evaluate the safety and tolerability of PXS-5505 in patients with primary, postpolycythemia vera (PV) or post-essential thrombocythemia (ET) myelofibrosis.
- Conditions
- Myelofibrosis, Primary Myelofibrosis (PMF), Post- Essential Thrombocythemia Myelofibrosis, Post Polycythemia Vera Myelofibrosis
- Trial name
- NCT04676529
- Testing
- PXS-5505
- Where
- 23 sites in United States, Australia and 2 more
- Volunteers
- 43 people
- Sponsor
- Syntara
Gaucher Disease, Type 1
A Gene Therapy Study in Patients With Gaucher Disease Type 1
This study is a first-in-human, open-label, safety, tolerability, and efficacy study in adult patients with Gaucher disease Type 1.
- Trial name
- GALILEO-1 (NCT05324943)
- Testing
- FLT201
- Where
- 10 sites in United States, Brazil and 4 more
- Volunteers
- 10 people
- Sponsor
- Spur Therapeutics
Painful Diabetic Peripheral Neuropathy
Gene Therapy for Painful Diabetic Neuropathy
The purpose of this open label, Phase I/II, dose-escalation, 3-cohort, multicenter, 12-month study, is to assess the safety and tolerability of injecting Engensis (VM202) in the leg muscle in patients with painful diabetic…
- Trial name
- NCT01002235
- Testing
- VM202
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Helixmith Co., Ltd.
Lymphoma
Study of AMG 531 to Evaluate the Safety & Efficacy in Patients With Non-Hodgkin's Lymphoma
The goal of this clinical research study is to find the highest safe dose of AMG 531 that can be given to treat thrombocytopenia (low platelet counts) in patients who have received chemotherapy.
- Trial name
- NCT00299182
- Testing
- AMG 531, Rituximab, Cyclophosphamide
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- M.D. Anderson Cancer Center
Hemophilia B
Safety and Dose Finding Study of DTX101 (AAVrh10FIX) in Adults With Moderate/Severe to Severe Hemophilia B
A Phase 1/2, open-label, dose-finding safety study of single ascending doses of DTX101 in adult males with moderate/severe to severe hemophilia B.
- Trial name
- NCT02618915
- Testing
- DTX101
- Where
- 9 sites in United States, Bulgaria and 1 more
- Volunteers
- 6 people
- Sponsor
- Ultragenyx Pharmaceutical Inc
Idiopathic Pulmonary Fibrosis
Study of ARO-MMP7 Inhalation Solution in Healthy Participants and Participants With Idiopathic Pulmonary Fibrosis
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ARO-MMP7 in normal healthy volunteers (NHVs) and in participants with idiopathic pulmonary fibrosis (IPF).
- Trial name
- NCT05537025
- Testing
- ARO-MMP7 Inhalation Solution
- Where
- 19 sites in Denmark, Italy and 4 more
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- Arrowhead Pharmaceuticals
Gastric Adenocarcinoma, Adenocarcinoma of the Gastroesophageal Junction
A Study of Ramucirumab Plus Pembrolizumab in Participants With Gastric or GEJ Adenocarcinoma, NSCLC, Transitional Cell Carcinoma of the Urothelium, or Biliary Tract Cancer
The main purpose of this study is to evaluate the safety and preliminary efficacy of the combination of the study drug known as ramucirumab plus pembrolizumab in participants with locally advanced and unresectable or metastatic…
- Conditions
- Gastric Adenocarcinoma, Adenocarcinoma of the Gastroesophageal Junction, Non-small Cell Lung Cancer, Carcinoma, Transitional Cell
- Trial name
- NCT02443324
- Testing
- Ramucirumab, Pembrolizumab
- Where
- 22 sites in United States, France and 4 more
- Volunteers
- 175 people
- Sponsor
- Eli Lilly and Company
Hepatocellular Carcinoma
Phase I/II Study of OPB-31121 in Patients With Progressive Hepatocellular Carcinoma
The purpose of this study is: Phase1: To evaluate the safety and determine the recommended dose (RD) Phase2: To evaluate the efficacy
- Trial name
- NCT01406574
- Testing
- OPB-31121, OPB-31121 phase2
- Where
- 2 sites in Japan
- Volunteers
- 23 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Respiratory Tract Infections
Acute Safety and Acceptability Study of Experimental Device RD19 for Protection From Human Respiratory Disease Pathogens
This first-in-man (FIM) phase I study will evaluate the acute safety, tolerability, and acceptability of the investigational RD19 device among 25 healthy volunteers between the age of 18 and 45.
- Trial name
- NCT04557826
- Testing
- RD19
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- EmitBio Inc.
Renal Impairment, Heart Failure
A Study of MK-7145 in Participants With Renal Insufficiency (Part I) and Heart Failure With Renal Insufficiency (Part II) (MK-7145-011)
Part I is a 3-period, active comparator-controlled, fixed sequence study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of MK-7145 compared to furosemide in participants with moderate-to-severe renal…
- Trial name
- NCT01558674
- Testing
- MK-7145, Furosemide, Torsemide
- Volunteers
- 11 people
- Sponsor
- Merck Sharp & Dohme LLC
Autism Spectrum Disorder
Open Label Phase I hCT-MSC in Toddlers With Autism Spectrum Disorder
This is a single site, prospective study of one intravenous infusion of human umbilical cord tissue-derived mesenchymal stromal cells (hCT-MSC) in toddlers with autism spectrum disorder (ASD).
- Trial name
- TACT (NCT04294290)
- Testing
- hCT-MSC infusion
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Duke University
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