Clinical trials: Phase I
Influenza
Safety and Immunogenicity of BPL-1357, A BPL-Inactivated, Whole-Virus, Universal Influenza Vaccine
Background: Influenza (flu) is a virus that infects people of all ages. Some people may have mild flu symptoms. Others may get very sick and even die from the flu.
- Trial name
- NCT05027932
- Testing
- BPL-1357
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Brain and Central Nervous System Tumors, Intraocular Melanoma
Iodine I 131 Monoclonal Antibody 3F8 in Treating Patients With Central Nervous System Cancer or Leptomeningeal Cancer
RATIONALE: Radiolabeled monoclonal antibodies, such as iodine I 131 monoclonal antibody 3F8, can find tumor cells and carry tumor-killing substances to them without harming normal cells.
- Conditions
- Brain and Central Nervous System Tumors, Intraocular Melanoma, Lung Cancer, Melanoma (Skin)
- Trial name
- NCT00445965
- Testing
- DNA analysis, immunologic technique, pharmacological study
- Where
- United States
- Volunteers
- 78 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Infant, Premature, Diseases, Brain White Matter Disease Periventricular
Initial Efficacy Study of Supporting Play, Exploration, & Early Development Intervention
The primary aims of this randomized controlled trial are to evaluate efficacy potential of SPEEDI at enhancing reaching and play based problem solving compared to infants receiving usual care.
- Trial name
- SPEEDI (NCT02153736)
- Testing
- SPEEDI Intervention
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Virginia Commonwealth University
Mucositis, Oral Complications
Acetylcysteine Rinse in Reducing Saliva Thickness and Mucositis in Patients With Head and Neck Cancer Undergoing Radiation Therapy
This randomized pilot clinical trial studies whether acetylcysteine oral rinse will lessen saliva thickness and painful mouth sores in patients with head and neck cancer undergoing radiation therapy.
- Conditions
- Mucositis, Oral Complications, Recurrent Adenoid Cystic Carcinoma of the Oral Cavity, Recurrent Basal Cell Carcinoma of the Lip
- Trial name
- NCT02123511
- Testing
- acetylcysteine, quality-of-life assessment, questionnaire administration
- Where
- 5 sites in United States
- Volunteers
- 34 people
- Sponsor
- Mayo Clinic
Advanced Solid Tumors or Non-Hodgkin's Lymphoma (NHL)
A Phase 1/2 Trial of SRA737 in Subjects With Advanced Cancer
The purpose of this clinical study is to establish the safety profile, determine the maximum tolerated dose (MTD) and recommend a Phase 2 dose and schedule of SRA737; and to evaluate the efficacy of SRA737 in…
- Trial name
- NCT02797964
- Testing
- SRA737
- Where
- 15 sites in United Kingdom
- Volunteers
- 107 people
- Sponsor
- Sierra Oncology LLC - a GSK company
Retinoschisis, X-Linked
Study of RS1 Ocular Gene Transfer for X-linked Retinoschisis
Background: X-linked juvenile retinoschisis (XLRS) is caused by changes in the RS1 gene. These changes cause abnormal function of the eye protein retinoschisin.
- Trial name
- NCT02317887
- Testing
- RS1 AAV Vector
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- VegaVect, Inc.
Renal Impairment
A Renal Impairment Study for PF-06651600
This is a Phase 1 non-randomized, open-label, parallel cohort study of PF-06651600 in subjects with severe renal impairment and subjects without renal impairment (Part 1) and in subjects with mild and moderate renal impairment…
- Trial name
- NCT04037865
- Testing
- PF-06651600
- Where
- 3 sites in United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Pfizer
Advanced Solid Tumors
A Study to Evaluate the Effect of Itraconazole and Rifampin on the Pharmacokinetics of Talazoparib in Patients With Advanced Solid Tumors
This is a study in patients with advanced solid tumors for the investigation of P-gp inhibition and induction on the PK of talazoparib.
- Trial name
- NCT03077607
- Testing
- Talazoparib, Itraconazole, Rifampin
- Where
- 7 sites in Hungary, Moldova and 2 more
- Volunteers
- 36 people
- Sponsor
- Pfizer
Healthy, PK Drug-drug Interaction Study
Study to Investigate the Safety, Tolerability and Pharmacokinetics of QEV-817 Oral Suspension
This study has been designed to assess the safety, tolerability, and pharmacokinetics of a therapeutic dose of hydrocodone bitartrate with and without an oral dose of doxapram hydrochloride in healthy volunteers who are…
- Trial name
- NCT06585163
- Testing
- Hydrocodone Bitartrate, Hydrocodone Bitartrate + Doxapram Hydrochloride
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Quivive Pharma, Inc.
Prostate Cancer
Samarium-153 With Neoadjuvant Hormonal and Radiation Therapy for Locally Advanced Prostate Cancer
The purpose of this study is to determine the safety and effectiveness of Samarium-153 when given in combination with hormonal and external beam radiation therapy in men with high risk prostate cancer.
- Trial name
- NCT00328614
- Testing
- Samarium-153, Total Androgen Suppression (TAS) with Bicalutamide, Total androgen suppression (TAS) with Goserelin Acetate
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Renal Impairment
A Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics and Safety of VIR-2218
The rationale of this study is to evaluate the impact of renal function on the PK, safety, and tolerability of VIR-2218 in participants with normal renal function and participants with varying degrees of renal dysfunction who are…
- Trial name
- NCT05844228
- Testing
- VIR-2218
- Where
- 3 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Vir Biotechnology, Inc.
Solid Tumor, Lymphoma
Study of MK-2118 Administered as Intratumoral Injection as Monotherapy and in Combination With Pembrolizumab (MK-3475) or by Subcutaneous Injection in Combination With Pembrolizumab in the Treatment of Adults With Advanced/Metastatic Solid Tumors or Lymphomas (MK-2118-001)
The purposes of this study are to: 1) assess the safety and tolerability and 2) establish a preliminary recommended Phase 2 dose (RP2D) and/or a maximum tolerated dose (MTD) or a maximum administered dose (MAD) of MK-2118 when…
- Trial name
- NCT03249792
- Testing
- MK-2118 (IT), MK-2118 (SC), Pembrolizumab
- Where
- 8 sites in United States, Israel
- Volunteers
- 140 people
- Sponsor
- Merck Sharp & Dohme LLC
Healthy
A Drug Drug Interaction (DDI) Study of Pirtobrutinib (LY3527727) and Rosuvastatin in Healthy Participants
The main purpose of this study is to determine the effect of pirtobrutinib on the levels of rosuvastatin in the blood stream in healthy participants.
- Trial name
- NCT05176314
- Testing
- Rosuvastatin, Pirtobrutinib
- Where
- 2 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Loxo Oncology, Inc.
Breast Cancer
A Study of Giredestrant (GDC-9545) in Postmenopausal Women With Stage I-III Operable, Estrogen Receptor-Positive Breast Cancer
This study will evaluate the pharmacodynamics, pharmacokinetics, safety, and biologic activity of giredestrant in participants with Stage I-III operable estrogen receptor (ER)-positive, human epidermal growth factor receptor 2…
- Trial name
- NCT03916744
- Testing
- Giredestrant, Surgery
- Where
- 15 sites in United States, Australia and 3 more
- Volunteers
- 75 people
- Sponsor
- Genentech, Inc.
Stage I Kidney Wilms Tumor, Stage II Kidney Wilms Tumor
Vincristine, Dactinomycin, and Doxorubicin With or Without Radiation Therapy or Observation Only in Treating Younger Patients Who Are Undergoing Surgery for Newly Diagnosed Stage I, Stage II, or Stage III Wilms' Tumor
This phase III trial is studying vincristine, dactinomycin, and doxorubicin with or without radiation therapy or observation only to see how well they work in treating patients undergoing surgery for newly diagnosed stage I…
- Conditions
- Stage I Kidney Wilms Tumor, Stage II Kidney Wilms Tumor, Stage III Kidney Wilms Tumor
- Trial name
- NCT00352534
- Testing
- 3-Dimensional Conformal Radiation Therapy, Biospecimen Collection, Chest Radiography
- Where
- 240 sites in United States, Australia and 5 more
- Volunteers
- 808 people
- Sponsor
- Children's Oncology Group
Healthy Subjects
Clinical Trial In Healthy Volunteers And Health Elderly Volunteers To Evaluate The Safety, Tolerability And Blood Concentration After Single And Multiple Escalating Oral Doses Of PF-06751979.
This study will test the safety, tolerability and blood concentrations of single and multiple oral doses of PF-06751979 in health subjects and healthy elderly subjects.
- Trial name
- NCT02793232
- Testing
- PF-06751979 single dose, PF-06751979 multiple ascending dose, PF-06751979 multiple dose
- Where
- Belgium
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Pfizer
Smoking
Phase I Study: Stop Smoking Therapy for Ontario Patients (STOP)
20% of Ontarians smoke. There was a decline in smoking prevalence from 1995 but it has remained unchanged since 2002. This rate of smoking cessation has not kept up with the rest of Canada.
- Trial name
- NCT00356993
- Testing
- Nicotine Replacement Therapy, behavioural intervention
- Where
- Canada
- Volunteers
- 6,009 people
- Sponsor
- Centre for Addiction and Mental Health
Chronic Myeloproliferative Disorders, Leukemia
Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer or Other Diseases
RATIONALE: Giving chemotherapy, such as fludarabine, busulfan, and melphalan, before a donor peripheral stem cell transplant or bone marrow transplant helps stop the growth of cancer or abnormal cells.
- Conditions
- Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm
- Trial name
- NCT00453206
- Testing
- allogeneic bone marrow transplantation, allogeneic hematopoietic stem cell transplantation, nonmyeloablative allogeneic hematopoietic stem cell transplantation
- Where
- United States
- Volunteers
- 66 people
- Sponsor
- Wake Forest University Health Sciences
Alzheimer's Disease
A Study to Evaluate the Safety, Tolerability, and Blood Levels of PF-03654746 in Subjects With Mild to Moderate Alzheimer's Disease
This is a study to evaluate the safety, tolerability and blood levels of PF-03654746 in subjects will mild to moderate Alzheimer's disease.
- Trial name
- NCT01028911
- Testing
- PF-03654746
- Where
- 2 sites in United States
- Volunteers
- 9 people
- Sponsor
- Pfizer
Diabetes Mellitus, Type 1
A Study To Assess The Safety Of PF-06342674 In Adults With Type 1 Diabetes
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of multiple doses of PF-06342674. Several dose levels will be evaluated.
- Trial name
- NCT02038764
- Testing
- PF-06342674 Dose A, PF-06342674 Dose B, PF-06342674 Dose C
- Where
- 21 sites in United States
- Volunteers
- 37 people
- Sponsor
- Pfizer
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