Clinical trials: Phase I
Chronic Myeloproliferative Disorders, Graft Versus Host Disease
Sirolimus, Tacrolimus, Thymoglobulin and Rituximab as Graft-versus-Host-Disease Prophylaxis in Patients Undergoing Haploidentical and HLA Partially Matched Donor Hematopoietic Cell Transplantation
This Phase II clinical trial was designed for patients with hematologic malignancies in need of donor peripheral blood stem cell transplant, and have no HLA matched donor.
- Conditions
- Chronic Myeloproliferative Disorders, Graft Versus Host Disease, Leukemia, Lymphoma
- Trial name
- NCT01116232
- Testing
- anti-thymocyte globulin, rituximab, sirolimus
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Barbara Ann Karmanos Cancer Institute
Type 2 Diabetes Mellitus
Study to Evaluate the Effects of a High-Fat Meal on Bexagliflozin in Healthy Subjects
The purpose of this study was to investigate the effect of a high-fat meal on the levels of bexagliflozin in the blood in healthy subjects.
- Trial name
- NCT02820298
- Testing
- Bexagliflozin
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Theracos
Graft Versus Host Disease, Leukemia
Clofarabine, Melphalan, and Thiotepa Followed By a Donor Stem Cell Transplant in Treating Patients With High-Risk and/or Advanced Hematologic Cancer or Other Disease
RATIONALE: Giving chemotherapy, such as clofarabine, melphalan, and thiotepa, before a donor stem cell transplant helps stop the growth of cancer or abnormal cells.
- Conditions
- Graft Versus Host Disease, Leukemia, Myelodysplastic Syndromes
- Trial name
- NCT00423514
- Testing
- filgrastim, clofarabine, melphalan
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Plaque, Gingivitis
Safety and Tolerability of Antiplaque Chewing Gum in a Gingivitis Population
This study is to assess the safety and tolerability of single doses and multiple doses in reducing plaque and gingivitis when delivered in a chewing gum formulation.
- Trial name
- APCG (NCT01877421)
- Testing
- 2 mg KSL-W, 4 mg KSL-W, 6 mg KSL-W
- Where
- United States
- Volunteers
- 135 people, healthy volunteers welcome
- Sponsor
- U.S. Army Medical Research and Development Command
Clear Cell Renal Cell Carcinoma, Stage I Renal Cell Cancer AJCC v6 and v7
Sunitinib Malate or Sorafenib Tosylate in Treating Patients With Kidney Cancer That Was Removed By Surgery
This randomized phase III trial studies sunitinib malate to see how well it works compared to sorafenib tosylate or placebo in treating patients with kidney cancer that has been removed by surgery.
- Conditions
- Clear Cell Renal Cell Carcinoma, Stage I Renal Cell Cancer AJCC v6 and v7, Stage II Renal Cell Cancer AJCC v7, Stage III Renal Cell Cancer AJCC v7
- Trial name
- ASSURE (NCT00326898)
- Testing
- Laboratory Biomarker Analysis, Quality-of-Life Assessment, Sorafenib Tosylate
- Where
- 987 sites in United States, Canada and 1 more
- Volunteers
- 1,943 people
- Sponsor
- National Cancer Institute (NCI)
Shigella Infection, Enterotoxigenic Escherichia Coli Infection
Shigella CVD 31000: Study of Responses With Shigella-ETEC Vaccine Strain CVD 1208S-122
The purpose of this study is to determine whether a live, oral, combined Shigella-ETEC vaccine candidate, known as strain CVD 1208S-122, is safe and immunogenic.
- Trial name
- NCT04634513
- Testing
- strain CVD 1208S-122
- Where
- United States
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- University of Maryland, Baltimore
Cutaneous Squamous Cell Carcinoma, Basal Cell Carcinoma
IFx-Hu2.0 for the Treatment of Patients With Skin Cancer
One hundred patients will receive IFx-Hu2.0 on an outpatient basis at a single time point in a single lesion. These patients will be assessed for any immediate adverse reactions and at Week 4 (Day 28+/-5 days) for any delayed…
- Trial name
- NCT04925713
- Testing
- IFx-Hu2.0
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- TuHURA Biosciences, Inc.
Hemophilia B
Ascending Dose Study of Genome Editing by Zinc Finger Nuclease Therapeutic SB-FIX in Subjects With Severe Hemophilia B
The purpose of the study is to evaluate the safety, tolerability and effect on FIX antigen and activity levels of ascending doses of SB-FIX.
- Trial name
- NCT02695160
- Testing
- SB-FIX
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Sangamo Therapeutics
Recurrent Anaplastic Large Cell Lymphoma, Recurrent Angioimmunoblastic T-Cell Lymphoma
Study of Pembrolizumab (MK-3475) in Combination With Romidepsin
This phase I/II trial studies the side effects of pembrolizumab and romidepsin and to see how well they work in treating participants with peripheral T-cell lymphoma that has come back or that does not respond to treatment.
- Conditions
- Recurrent Anaplastic Large Cell Lymphoma, Recurrent Angioimmunoblastic T-Cell Lymphoma, Recurrent Mature T- and NK-Cell Non-Hodgkin Lymphoma, Recurrent Mycosis Fungoides
- Trial name
- NCT03278782
- Testing
- Pembrolizumab, Romidepsin
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- M.D. Anderson Cancer Center
Malaria
Trial of a Falciparum Malaria Protein (FMP012), E. Coli-expressed PfCelTOS, in Healthy Malaria-Naive Adults
Malaria has remained a major concern for the US military. During World War II, malaria was the leading cause of disease and non-battle injury with 500-700 men infected per day, resulting in 24,000 malaria-related casualties.(10)…
- Trial name
- NCT01540474
- Testing
- Group 1: 10 ug FMP012 with 2 ug GLA-SE, Group 2: 10 ug FMP012 with 5 ug GLA-SE, 50 ug FMP012 with 5 ug GLA-SE or 2 ug GLA-SE
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- U.S. Army Medical Research and Development Command
Spinal Muscular Atrophy Type I
Clinical Trial of Sodium Phenylbutyrate in Children With Spinal Muscular Atrophy Type I
The purpose of this study is to identify the maximum tolerated dosage of sodium phenylbutyrate in children with spinal muscular atrophy type I; and to determine if the drug has an effect on SMN mRNA and protein levels.
- Trial name
- NPTUNE 02 (NCT00439218)
- Testing
- sodium phenylbutyrate
- Where
- 5 sites in United States
- Volunteers
- 5 people
- Sponsor
- Westat
Mixed Mesodermal (Mullerian) Tumor, Ovarian Carcinosarcoma
Paclitaxel and Carboplatin or Ifosfamide in Treating Patients With Newly Diagnosed, Persistent or Recurrent Uterine, Ovarian, Fallopian Tube, or Peritoneal Cavity Cancer
This randomized phase III trial studies paclitaxel and carboplatin see how well they work compared with paclitaxel and ifosfamide in treating patients with fallopian tube, or peritoneal cavity cancer that is newly diagnosed…
- Conditions
- Mixed Mesodermal (Mullerian) Tumor, Ovarian Carcinosarcoma, Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma
- Trial name
- NCT00954174
- Testing
- Carboplatin, Ifosfamide, Paclitaxel
- Where
- 538 sites in United States, South Korea
- Volunteers
- 637 people
- Sponsor
- GOG Foundation
Healthy Volunteer
A Study to Evaluate the Effect of a Proton-Pump Inhibitor (Rabeprazole) on the Relative Bioavailability of Cobimetinib in Healthy Participants
This is a Phase 1, single-center, open-label, randomized, 3-period, 2-sequence crossover study of cobimetinib in healthy participants to evaluate the effect of the proton-pump inhibitor (PPI) rabeprazole on the relative…
- Trial name
- NCT01277718
- Testing
- Cobimetinib, Rabeprazole
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Genentech, Inc.
Solid Tumors and Hematologic Malignancy
An Open-Label, Dose-Escalation Study of INCB054329 in Patients With Advanced Malignancies
This was a study of INCB054329 given to patients with advanced malignancies that were conducted in three treatment groups. Each treatment group had a dose escalation (Part 1) and a dose expansion (Part 3), two of the treatment…
- Trial name
- NCT02431260
- Testing
- INCB054329 Monotherapy
- Where
- 12 sites in United States
- Volunteers
- 69 people
- Sponsor
- Incyte Corporation
Bipolar Disorder
Efficacy and Safety of Ramelteon Sublingual as Adjunctive Therapy for Maintenance Treatment of Bipolar I Disorder
The purpose of this study is to determine the efficacy and safety of ramelteon, once nightly before bedtime (QHS), sublingual (SL), in the maintenance treatment of Bipolar I Disorder in adult patients.
- Trial name
- NCT01467713
- Testing
- Ramelteon SL
- Where
- 156 sites in United States, Argentina and 3 more
- Volunteers
- 642 people
- Sponsor
- Takeda
Healthy Volunteers
Phase 1, TAK-915-1001, Single-Rising Dose, Multiple-Rising Dose, Drug-Drug Interaction, Relative Bioavailability, Food Effect, and Effect on Elderly Participants Study
The purpose of this study is to characterize the safety, tolerability and plasma pharmacokinetic (PK) profile of TAK-915 when administered as single and multiple oral suspension doses at escalating dose levels in healthy…
- Trial name
- NCT02461160
- Testing
- TAK-915 suspension, Midazolam, TAK-915 tablet
- Where
- United States
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Takeda
Breast Cancer
Study Evaluating The Combination Of Neratinib And Capecitabine In Solid Tumors And Breast Cancer
This is a world wide phase 1/2, open-label, study of neratinib in combination with capecitabine, conducted in 2 parts. In Part 1, 3 to 9 subjects with solid tumors will be enrolled in each dose group of the combination of…
- Trial name
- NCT00741260
- Testing
- Neratinib, Capecitabine
- Where
- 37 sites in United States, Australia and 9 more
- Volunteers
- 105 people
- Sponsor
- Puma Biotechnology, Inc.
Healthy
A Study to Understand the Effect of a Study Medicine Called ARV-471 on Dabigatran Etexilate in Healthy Adults
The purpose of this study is to understand if ARV-471 affects how a medicine called, dabigatran etexilate, gets absorbed or processed into the body in healthy adults.
- Trial name
- NCT05673889
- Testing
- ARV-471, Dabigatran etexilate
- Where
- Belgium
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
Corneal Endothelial Dystrophy, Fuchs Endothelial Corneal Dystrophy
A Phase 1/ Phase 2 Study of TTHX1114(NM141)
Prospective, multicenter, randomized, masked, vehicle-controlled, dose-escalation study
- Conditions
- Corneal Endothelial Dystrophy, Fuchs Endothelial Corneal Dystrophy, Pseudophakic Bullous Keratopathy, Endothelial Dysfunction
- Trial name
- INTREPID (NCT04520321)
- Testing
- TTHX1114(NM141)
- Where
- 8 sites in United States
- Volunteers
- 22 people
- Sponsor
- Trefoil Therapeutics, Inc.
Multiple Myeloma, Stage I Multiple Myeloma
Cyclophosphamide, Carfilzomib, Thalidomide, and Dexamethasone in Treating Patients With Newly Diagnosed Active Multiple Myeloma
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
- Conditions
- Multiple Myeloma, Stage I Multiple Myeloma, Stage II Multiple Myeloma, Stage III Multiple Myeloma
- Trial name
- NCT01057225
- Testing
- carfilzomib, cyclophosphamide, thalidomide
- Where
- 3 sites in United States
- Volunteers
- 64 people
- Sponsor
- Mayo Clinic
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