Clinical trials: Phase I
Healthy
A Phase 1/2A Study to Evaluate the Safety, Immunogenicity, and Shedding of MEDI-560 in Infants 1 to < 12 Months of Age
The primary objective of this study is to describe the safety and tolerability of 3 doses of MEDI-560 at 10^5 TCID50 when administered to children 6 to < 12 months of age who are HPIV3 (human parainfluenza virus type 3)…
- Trial name
- NCT00508651
- Testing
- MEDI-560
- Where
- 23 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- MedImmune LLC
Relapsed/Refractory Multiple Myeloma
Study Evaluating ABT-199 in Participants With Relapsed or Refractory Multiple Myeloma
The Phase 1 primary objectives of this study were to assess the safety profile, characterize pharmacokinetics (PK) and determine the dosing schedule, maximum tolerated dose (MTD), and recommended Phase 2 dose (RPTD) of ABT-199…
- Trial name
- NCT01794520
- Testing
- Venetoclax, Dexamethasone
- Where
- 29 sites in United States, Belgium and 2 more
- Volunteers
- 117 people
- Sponsor
- AbbVie
Diffuse Large B Cell Lymphoma
Dose Escalation Study in Patients With Relapsed or Refractory DLBCL and MyD88 L265P Mutation
Recent reports have identified a specific oncogenic mutation L265P of the MYD88 gene in approximately 30% of the patients with the activated B-cell (ABC) type of Diffuse Large B Cell Lymphoma (DLBCL).
- Trial name
- NCT02252146
- Testing
- IMO-8400
- Where
- 12 sites in United States
- Volunteers
- 6 people
- Sponsor
- Idera Pharmaceuticals, Inc.
Solid Tumor
Safety Study of PLX108-01 in Patients With Solid Tumors
PLX3397 is a selective inhibitor of Fms, Kit, and oncogenic Flt3 activity. The primary objective of this study is to evaluate the safety and pharmacokinetics of orally administered PLX3397 in patients with advanced, incurable…
- Trial name
- NCT01004861
- Testing
- PLX3397
- Where
- 13 sites in United States
- Volunteers
- 132 people
- Sponsor
- Daiichi Sankyo
Bacterial Infection, Multiple-drug Resistance
Intravenous Fosfomycin Pharmacokinetics Study
This is a Phase 1, open-label, multiple-dose trial conducted at a single center. The treatment period will consist of three 6 g doses (18 g) of ZTI-01 as a 1-hour intravenous (IV) infusion (+10 minute window).
- Conditions
- Bacterial Infection, Multiple-drug Resistance, Pathogen Resistance
- Trial name
- NCT03910673
- Testing
- Fosfomycin disodium
- Where
- United States
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Relapsed or Refractory Multiple Myeloma
Vorinostat (MK-0683, SAHA [Suberoylanilide Hydroxamic Acid]) + Lenalidomide + Dexamethasone in Multiple Myeloma (MM) (MK-0683-074)
The purpose of this Phase I study of vorinostat in combination with lenalidomide and dexamethasone in participants with relapsed or refractory multiple myeloma is to determine the maximum tolerated dose (MTD) as estimated by the…
- Trial name
- NCT00642954
- Testing
- Vorinostat, Lenalidomide, Dexamethasone
- Volunteers
- 31 people
- Sponsor
- Merck Sharp & Dohme LLC
Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm
Testing the Sequential Combination of the Anti-cancer Drugs Olaparib Followed by Adavosertib (AZD1775) in Patients With Advanced Solid Tumors With Selected Mutations and PARP Resistance, STAR Study
This phase I trial studies the side effects and best dose of adavosertib when given together with olaparib in treating patients with solid tumors that have spread to other places in the body (advanced) with selected mutations.
- Conditions
- Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Refractory Malignant Solid Neoplasm, Unresectable Malignant Solid Neoplasm
- Trial name
- NCT04197713
- Testing
- Adavosertib, Olaparib
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- National Cancer Institute (NCI)
Influenza
Reverse Genetic H9N2 Influenza Vaccine Study in Adults
The purpose of the study is to identify the optimal dose level of a reverse genetic (RG) reassortant H9N2 pandemic influenza vaccine for further product development.
- Trial name
- NCT01320696
- Testing
- Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine
- Where
- 5 sites in United States
- Volunteers
- 353 people, healthy volunteers welcome
- Sponsor
- Alachua Government Services, Inc.
Neutropenia, Breast Cancer
Study of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy
A Phase I, dose escalation study to evaluate the safety and pharmacokinetics/pharmacodynamics of F-627 in female breast cancer patients who received up to 4 cycles of Epirubicin and Cyclophosphamide.
- Trial name
- NCT02527746
- Testing
- F-627, EC regimen
- Volunteers
- 18 people
- Sponsor
- EVIVE Biotechnology
Stomach Neoplasms
Study Of Sunitinib With S-1 And Cisplatin For Gastric Cancer
To assess the maximal tolerated dose (MTD) and overall safety of sunitinib when administered in combination with S-1 and Cisplatin in patients with advanced/metastatic gastric cancer.
- Trial name
- NCT00553696
- Testing
- Cisplatin, S-1, Sunitinib
- Where
- 3 sites in Japan
- Volunteers
- 27 people
- Sponsor
- Pfizer
Allergic Rhinoconjunctivitis
Subcutaneous Immunotherapy in Patients Sensitized to Dermatophagoides Pteronyssinus (DPT)
Based on EMA (European Medicines Agency) new guidelines on the clinical development of products for immunotherapy for the treatment of allergic diseases the aim of this study was to assess safety and tolerability of 3 different…
- Trial name
- NCT01489020
- Testing
- subcutaneous immunotherapy with DPT extract
- Where
- 2 sites in Spain
- Volunteers
- 48 people
- Sponsor
- Roxall Medicina España S.A
Healthy
A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood
This study aims to investigate the effect of multiple doses of BI 1358894 on pharmacokinetics of ethinylestradiol (EE) and drospirenone (DRSP) (Yasmin®)
- Trial name
- NCT05934942
- Testing
- Yasmin®, BI 1358894
- Where
- Germany
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Vulvar Atrophy
Study of Intravaginal Tamoxifen in PostMenopausal Women With VVA
The purpose of the study is to study the safety, PK and PD of Intravaginal Tamoxifen on postmenopausal women with vulvar vaginal atrophy.
- Trial name
- DARE-VVA1 (NCT05378269)
- Testing
- Tamoxifen
- Where
- 2 sites in Australia
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Daré Bioscience, Inc.
Relapsed/Refractory Multiple Myeloma
Study to Evaluate the Safety and Efficacy of KITE-585 in Participants With Relapsed/Refractory Multiple Myeloma
The primary objective of the study is to evaluate the safety and tolerability of KITE-585, an autologous engineered chimeric antigen receptor (CAR) T-cell product targeting a protein commonly found on myeloma cells called B-cell…
- Trial name
- NCT03318861
- Testing
- KITE-585, Cyclophosphamide, Fludarabine
- Where
- 9 sites in United States
- Volunteers
- 17 people
- Sponsor
- Kite, A Gilead Company
COVID-19, SARS-CoV-2
Safety and Immunogenicity Study of a Booster Dose of the Investigational CV0501 mRNA COVID-19 Vaccine in Adults at Least 18 Years Old
Prevention of COVID-19 caused by SARS-CoV-2.
- Trial name
- NCT05477186
- Testing
- CV0501 (3 μg), CV0501 (6 μg), CV0501 (12 μg)
- Where
- 17 sites in United States, Australia and 1 more
- Volunteers
- 185 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Alpha-1 Antitrypsin Deficiency (AATD)
A Phase 1 Research Study to Evaluate Safety, Tolerability, and Pharmacokinetics of WVE-006 in Healthy Participants With Wild-type AAT Expression (RestorAATion-1)
This study is the first study in the RestorAATion clinical program. The purpose of this first-in human (FIH), double-blind, randomized, placebo-controlled, single ascending dose (SAD) and multiple-dose Phase 1 study is to assess…
- Trial name
- RestorAATion-1 (NCT06186492)
- Testing
- WVE-006
- Where
- United Kingdom
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Wave Life Sciences USA, Inc.
Carcinoma, Non-Small-Cell Lung
Dose Escalating Study of the Safety and Efficacy of Patupilone, q3w, in Patients With Non-small Cell Lung Cancer
The study objective is to evaluate the maximum tolerated dose, safety and efficacy of patupilone in patients with NSCLC who have progressed after prior chemotherapy.
- Trial name
- NCT00171834
- Testing
- Patupilone
- Where
- 4 sites in United States
- Volunteers
- 89 people
- Sponsor
- Novartis Pharmaceuticals
Adult Acute Lymphoblastic Leukemia, Adult Acute Myeloid Leukemia
Sirolimus, Cyclosporine, and Mycophenolate Mofetil in Preventing Graft-versus-Host Disease in Treating Patients With Blood Cancer Undergoing Donor Peripheral Blood Stem Cell Transplant
This phase II trial studies how well sirolimus, cyclosporine and mycophenolate mofetil works in preventing graft-vs-host disease (GVHD) in patients with blood cancer undergoing donor peripheral blood stem cell (PBSC) transplant.
- Conditions
- Adult Acute Lymphoblastic Leukemia, Adult Acute Myeloid Leukemia, Adult Diffuse Large B-Cell Lymphoma, Adult Myelodysplastic Syndrome
- Trial name
- NCT01251575
- Testing
- Allogeneic Hematopoietic Stem Cell Transplantation, Cyclosporine, Fludarabine Phosphate
- Where
- 5 sites in United States, Denmark
- Volunteers
- 77 people
- Sponsor
- Fred Hutchinson Cancer Center
Renal Insufficiency
Pharmacokinetics, Safety and Tolerability of the Combination of BI 207127 and Faldaprevir in Renal Impaired Patients
The objective of the trial is to investigate the effect of different degrees of renal impairment on the pharmacokinetics and safety of the combination of BI 207127 and faldaprevir after 3 days of dosing (BI 207127 bid…
- Trial name
- NCT01957657
- Testing
- BI 207127, faldaprevir
- Where
- Germany
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy Volunteers
A Pilot Study to Compare the Pharmacokinetics (PK) of Single Subcutaneous (SC) Injections of Vedolizumab Administered in Prefilled Syringe (PFS) Versus (vs) Prefilled Syringe in Needle Safety Device (PFS+NSD) in Healthy Participants
The purpose of this study is to compare the PK of single dose of vedolizumab SC 108 milligram (mg) administered as PFS vs investigational device.
- Trial name
- NCT03948581
- Testing
- Vedolizumab SC
- Where
- United States
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- Takeda
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