Clinical trials: Phase I
Solid Tumor
Study of MK-4166 and MK-4166 in Combination With Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-4166-001)
This is planned to be a 5-part dose-escalation study to determine the safety and tolerability of MK-4166 monotherapy and MK-4166 plus pembrolizumab combination therapy, and to establish the maximum tolerated dose (MTD) or maximum…
- Trial name
- NCT02132754
- Testing
- MK-4166, Pembrolizumab
- Volunteers
- 116 people
- Sponsor
- Merck Sharp & Dohme LLC
Leukemia, Lymphoma
Rituximab, Cyclophosphamide, and Pegfilgrastim in Treating Patients With Leukemia or Non-Hodgkin's Lymphoma
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread.
- Trial name
- NCT00278161
- Testing
- Pegfilgrastim, Rituximab, Cyclophosphamide
- Where
- United States
- Volunteers
- 94 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Respiratory Syncytial Virus Infections
Evaluating the Infectivity, Safety and Immunogenicity of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine in RSV-Seronegative Infants 6 to 24 Months of Age
The purpose of this study was to evaluate the safety, infectivity, and immunogenicity of a single dose of a recombinant live-attenuated respiratory syncytial virus (RSV) vaccine in RSV-seronegative infants 6 to 24 months of age.
- Trial name
- NCT02794870
- Testing
- RSV LID ΔM2-2 1030s vaccine
- Where
- 8 sites in United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Hookworm Disease, Hookworm Infection
Study of Co-administered Na-APR-1 (M74) and Na-GST-1 in Gabonese Children
Double blind, randomized, controlled, dose-escalation Phase 1 clinical trial in hookworm-exposed children aged 6 to 10 years living in the area of Lambaréné, Gabon.
- Trial name
- NCT02839161
- Testing
- Na-GST-1/Alhydrogel, Na-APR-1 (M74)/Alhydrogel, Hepatitis B Vaccine
- Where
- Gabon
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Baylor College of Medicine
Waldenstrom's Macroglobulinemia, Non-Hodgkin's Lymphoma
Safety Study of the Proteasome Inhibitor PR-171 (Carfilzomib for Injection) in Patients With Hematological Malignancies
The purpose of this study is to test the safety and tolerability of carfilzomib at different dose levels on hematological cancers such as multiple myeloma, non-Hodgkin's lymphoma, Hodgkin's disease, or Waldenstrom's…
- Conditions
- Waldenstrom's Macroglobulinemia, Non-Hodgkin's Lymphoma, Hodgkin's Disease, Multiple Myeloma
- Trial name
- NCT00150462
- Testing
- Carfilzomib, Dexamethasone
- Where
- 5 sites in United States
- Volunteers
- 48 people
- Sponsor
- Amgen
Stage 0 Breast Cancer, Stage I Breast Cancer
Web-Based Decision Aid in Improving Informed Decisions in Patients With Stage 0-IIIA Breast Cancer Considering Contralateral Prophylactic Mastectomy
This pilot randomized clinical trial studies how well a web-based decision aid works in improving informed decisions in patients with stage 0-IIIA breast cancer considering contralateral prophylactic mastectomy (CPM).
- Conditions
- Stage 0 Breast Cancer, Stage I Breast Cancer, Stage IA Breast Cancer, Stage IB Breast Cancer
- Trial name
- NCT03061175
- Testing
- Internet-Based Intervention, Survey Administration
- Where
- 3 sites in United States
- Volunteers
- 94 people
- Sponsor
- Rutgers, The State University of New Jersey
Triple-negative Breast Cancer
Neoadjuvant Study of Two Platinum Regimens in Triple Negative Breast Cancer
Evaluate if the two carboplatin containing chemotherapy regimens will reduce the growth of breast cancer cells in women with Stage I, II, or III triple negative breast cancer.
- Trial name
- NeoSTOP (NCT02413320)
- Testing
- Paclitaxel, Carboplatin, Doxorubicin
- Where
- 9 sites in United States
- Volunteers
- 101 people
- Sponsor
- Priyanka Sharma
Carcinoma, Small Cell
Investigation of GSK2879552 in Subjects With Relapsed/Refractory Small Cell Lung Carcinoma
GSK2879552 is a potent, selective, mechanism-based inactivator of Lysine Specific Demethylase 1 (LSD1)/ CoRepressor for Element-1-Silencing Transcription factor (CoREST) activity.
- Trial name
- NCT02034123
- Testing
- GSK2879552
- Where
- 8 sites in United States, France and 1 more
- Volunteers
- 29 people
- Sponsor
- GlaxoSmithKline
Prostate Cancer
CP-675,206 in Combination With Short Term Androgen Deprivation in Patients With Stage D0 Prostate Cancer
The current protocol will evaluate the safety of combining treatment with bicalutamide(Casodex) and CP-675,206 (anti-CTLA-4 monoclonal antibody) in patients with PSA-recurrent non-metastatic (stage D0) prostate cancer.
- Trial name
- NCT00702923
- Testing
- Bicalutamide and CP-675,206 (Tremelimumab), Bicalutamide, CP-675,206 (tremelimumab), Bicalutamide, CP-675,206
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- University of Wisconsin, Madison
Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL)
A Study Evaluating the Safety, Tolerability, Pharmacokinetics and Preliminary Activity of Idasanutlin in Combination With Either Chemotherapy or Venetoclax in Treatment of Pediatric and Young Adult Participants With Relapsed/Refractory Acute Leukemias or Solid Tumors
This is a Phase I/II, multicenter, open-label, multi-arm study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of idasanutlin, administered as a single agent or in combination with…
- Conditions
- Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), Neuroblastoma, Solid Tumors
- Trial name
- NCT04029688
- Testing
- Idasanutlin, Venetoclax, Cyclophosphamide
- Where
- 14 sites in United States, Canada and 4 more
- Volunteers
- 38 people
- Sponsor
- Hoffmann-La Roche
Pharmacokinetics
Crossover Study of the Safety and PK Properties of Proellex®
Study to evaluate the PK of 25 mg and 50 mg of Proellex from 2 different suppliers in the fed and fasting states.
- Trial name
- NCT00749879
- Testing
- Proellex
- Where
- United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Repros Therapeutics Inc.
Urothelial Carcinoma, Urothelial Cancer
Trial of EP0057, a Nanoparticle Camptothecin With Olaparib in People With Relapsed/Refractory Small Cell Lung Cancer
Background: EP0057 (formerly CRLX101) consists of a sugar molecule cyclodextrin linked to a chemotherapy drug called camptothecin. The combined molecule or "nanoparticle drug conjugate" travels through the blood.
- Conditions
- Urothelial Carcinoma, Urothelial Cancer, Lung Neoplasms, Small Cell Lung Cancer
- Trial name
- NCT02769962
- Testing
- EP0057, olaparib, CT scan
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- National Cancer Institute (NCI)
Huntington's Disease
Study to Measure Cerebrospinal Fluid Mutant Huntingtin Protein in Participants With Early Manifest Stage I or Stage II Huntington's Disease
The study is designed as a multi-site, prospective, 15-month longitudinal, cohort study measuring CSF mHTT in participants with early manifest Stage I or Stage II Huntington's Disease (HD).
- Trial name
- NCT03664804
- Testing
- No Study Drug was Administered in this Study
- Where
- 15 sites in United States, Canada and 2 more
- Volunteers
- 95 people
- Sponsor
- Hoffmann-La Roche
Advanced Solid Tumors, Neoplasms
Safety And PK Study Of CVX-060 In Patients With Advanced Solid Tumors
The purpose of this study is to determine the safety and tolerability of CVX-060 in patients with advanced solid tumors.
- Conditions
- Advanced Solid Tumors, Neoplasms, Carcinoma, Cancer
- Trial name
- NCT00879684
- Testing
- CVX-060
- Where
- 4 sites in United States
- Volunteers
- 34 people
- Sponsor
- Pfizer
Enterovirus Infection
Phase 1, Randomized, Double-Blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of an Enterovirus D68-specific Monoclonal Antibody in Healthy Adults
This is a Phase 1, randomized, placebo-controlled, double-blinded study to assess the safety and pharmacokinetics of single IV administrations of EV68-228-N in healthy adult volunteers.
- Trial name
- NCT06444048
- Testing
- EV68-228-N
- Where
- 2 sites in United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Healthy
The Pharmacokinetics of Rocaltrol When Administered Alone or in Combination With Fosrenol or Renvela in Healthy Volunteers
To assess the effects of lanthanum carbonate (FOSRENOL) or sevelamer carbonate (RENVELA) on the pharmacokinetics of oral calcitriol (ROCALTROL)
- Trial name
- NCT00925704
- Testing
- Calcitriol, Lanthanum carbonate + Calcitriol, Sevelamer carbonate + Calcitriol
- Where
- United States
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Shire
Recurrent Prostate Carcinoma, Stage I Prostate Cancer
Metformin Hydrochloride and Aspirin in Treating Patients With Hormone-Dependent Prostate Cancer That Has Progressed After Surgery or Radiation Therapy
This randomized phase II trial studies how well metformin hydrochloride and aspirin work in treating patients with hormone-dependent prostate cancer that has progressed after surgery or radiation therapy.
- Conditions
- Recurrent Prostate Carcinoma, Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer
- Trial name
- PRIMA (NCT02420652)
- Testing
- Aspirin, Laboratory Biomarker Analysis, Metformin Hydrochloride
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- Rutgers, The State University of New Jersey
Vulvovaginal Atrophy, Vasomotor Symptoms
A Phase 1, Open-Label, Parallel Group Study to Evaluate the Pharmacokinetics and Safety of DARE-HRT1 in Healthy PostMenopausal Women
An open-label study to assess the PK of estradiol, estrone and progesterone from the DARE-HRT1 intravaginal rings at two different dose strengths.
- Trial name
- NCT05418426
- Testing
- IVR Dose 1, IVR Dose 2, Oral Reference
- Where
- 2 sites in Australia
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Daré Bioscience, Inc.
Leukemia, Lymphocytic
Human IL-15 (rhIL-15) and Obinutuzumab for Relapsed and Refractory Chronic Lymphocyte Leukemia
Background: Chronic lymphocytic leukemia (CLL) is a blood cancer. Recombinant human interleukin 15 (IL-15) is a manmade protein. Obinutuzumab is a protein made to deactivate cancer cells.
- Conditions
- Leukemia, Lymphocytic, Chronic, B-Cell
- Trial name
- NCT03759184
- Testing
- rhIL-15, Obinutuzumab
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- National Cancer Institute (NCI)
Mitochondrial Myopathy
Safety, Tolerability, and Efficacy of MTP-131 for the Treatment of Mitochondrial Myopathy
Phase 1/2, multi-center, randomized, double-blind, multiple ascending dose, placebo-controlled study that enrolled 36 subjects with mitochondrial myopathy associated with genetically confirmed mitochondrial disease to evaluate…
- Trial name
- MMPOWER (NCT02367014)
- Testing
- elamipretide (low dose), elamipretide (intermediate dose), elamipretide (high dose)
- Where
- 4 sites in United States
- Volunteers
- 36 people
- Sponsor
- Stealth BioTherapeutics Inc.
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