Clinical trials: Phase 1b
Soft Tissue Sarcoma
A Study of Olaratumab (LY3012207) in Participants With Advanced Soft Tissue Sarcoma
The main purpose of this study is to evaluate the safety and efficacy of two anti-cancer drugs (gemcitabine and docetaxel) with and without the study drug known as olaratumab in participants with advanced soft tissue sarcoma…
- Trial name
- ANNOUNCE 2 (NCT02659020)
- Testing
- Olaratumab, Gemcitabine, Docetaxel
- Where
- 48 sites in United States, Australia and 8 more
- Volunteers
- 310 people
- Sponsor
- Eli Lilly and Company
Tuberculosis
Safety and Immunogenicity Study of BCG, H4:IC31, and H56:IC31 Revaccination in Healthy Adolescents
The aims of the phase 1b trial described here are to facilitate identification of assays and immune responses that could then be evaluated as correlates of risk and correlates of protection in efficacy studies and ultimately to…
- Trial name
- NCT02378207
- Testing
- H4:IC31, H56:IC31, BCG
- Where
- South Africa
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Aeras
Acute Myeloid Leukemia
Pinometostat With Standard Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia and MLL Gene Rearrangement
This phase Ib/II trial studies the side effects and best dose of pinometostat and how well it works with standard chemotherapy in treating patients with newly diagnosed acute myeloid leukemia and a type of genetic mutation called…
- Trial name
- NCT03724084
- Testing
- Cytarabine, Daunorubicin, Daunorubicin Hydrochloride
- Where
- 3 sites in United States
- Volunteers
- 6 people
- Sponsor
- National Cancer Institute (NCI)
Spasticity Due to Cerebral Palsy
Phase 1b Study of Tizanidine in Pediatric Patients With Cerebral Palsy
A Single-Dose, Phase 1b, Multicenter, Open-Label Study to Assess the Pharmacokinetics, Safety and Tolerability, and Pharmacodynamics of Tizanidine at 4 Different Oral Dose Levels in Pediatric Subjects 2 to 16 Years Old With Mild…
- Trial name
- NCT01405950
- Testing
- Zanaflex Capsules
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Acorda Therapeutics
Neoplasms, Solid Tumors
A Study of Robatumumab (SCH 717454, MK-7454) in Combination With Different Treatment Regimens in Pediatric Participants With Advanced Solid Tumors (P05883, MK-7454-006)
This is a Phase 1/1B, non-randomized, open-label, dose-escalation study of robatumumab (SCH 717454, MK-7454) administered in combination with chemotherapy in pediatric participants with solid tumors, to be conducted in…
- Conditions
- Neoplasms, Solid Tumors, Bone Cancer, Kidney Tumor
- Trial name
- NCT00960063
- Testing
- Temozolomide, Vincristine, Ifosfamide
- Volunteers
- 4 people
- Sponsor
- Merck Sharp & Dohme LLC
Diarrhoea
A Study on the Safety and Immune Responses to the GVGH altSonflex1-2-3 Vaccine Against Shigellosis in Adults, Children, and Infants
The aim of the current clinical study was to evaluate, for the first time in humans (FTIH), the safety and immunogenicity of the altSonflex1-2-3 candidate vaccine against S. sonnei and S. flexneri serotypes 1b, 2a, and 3a.
- Trial name
- NCT05073003
- Testing
- AltSonflex1-2-3 High Dose, AltSonflex1-2-3 Medium Dose, AltSonflex1-2-3 Low Dose
- Where
- 2 sites in Belgium, Kenya
- Volunteers
- 551 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Acute-graft-versus-host Disease, aGVHD
A Study to Evaluate the Safety, Tolerability, PK, PD, and Clinical Activity of EQ001 in Subjects With aGVHD
This is a multi-center study to evaluate the safety, tolerability, PK, PD, and clinical activity of EQ001 in subjects with Acute Graft Versus Host Disease (aGVHD).
- Conditions
- Acute-graft-versus-host Disease, aGVHD, GVHD, GVHD, Acute
- Trial name
- EQUATE (NCT03763318)
- Testing
- EQ001
- Where
- 16 sites in United States
- Volunteers
- 30 people
- Sponsor
- Biocon Limited
Fungal Infections
A Study of the Safety, Tolerance, and Pharmacokinetics of Oral Posaconazole in Immunocompromised Children (P03579)
The purpose of this dose-escalation study is to evaluate the pharmacokinetics, safety, and tolerability of oral posaconazole in immunocompromised children with neutropenia or expected neutropenia.
- Trial name
- NCT01716234
- Testing
- Posaconazole 12 mg/kg/day BID, Posaconazole 18 mg/kg/day BID, Posaconazole 18 mg/kg/day TID
- Volunteers
- 142 people
- Sponsor
- Merck Sharp & Dohme LLC
Respiratory Syncytial Virus
A Phase 1b/2a Randomized, Double-Blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Preterm Infants
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of an extended half-life anti-respiratory syncytial virus (RSV) monoclonal antibody compared to placebo when administered to healthy preterm…
- Trial name
- MEDI8897 1b (NCT02290340)
- Testing
- MEDI8897 10 mg, MEDI8897 25 mg, MEDI8897 50 mg
- Where
- 13 sites in United States, Chile and 1 more
- Volunteers
- 151 people, healthy volunteers welcome
- Sponsor
- MedImmune LLC
Respiratory Syncytial Virus Infections
A Study to Learn About the Amount of the Study Medicine (Sisunatovir) in Blood and Its Safety in Infants and Children With Pneumonia Caused by RSV
The purpose of the study is to learn about the safety and amount of sisunatovir in the blood of infants and children up to age 60 months.
- Trial name
- NCT06102174
- Testing
- Active
- Where
- 9 sites in United States, Japan and 1 more
- Volunteers
- 10 people
- Sponsor
- Pfizer
Duchenne Muscular Dystrophy
A Study to Evaluate the Safety and Tolerability of PF-06939926 Gene Therapy in Duchenne Muscular Dystrophy
This is a first-in-human/first-in-patient, multi-center, open-label, non-randomized, ascending dose, safety and tolerability study of a single intravenous infusion of PF-06939926 in ambulatory and non-ambulatory subjects with…
- Trial name
- NCT03362502
- Testing
- PF-06939926
- Where
- 22 sites in United States
- Volunteers
- 23 people
- Sponsor
- Pfizer
Malignant Glioma, Anaplastic Astrocytoma
Phase 1b Study PVSRIPO for Recurrent Malignant Glioma in Children
The purpose of the study is to confirm the safety of the selected dose and potential toxicity of oncolytic poliovirus (PV) immunotherapy with PVSRIPO for pediatric patients with recurrent WHO grade III or IV malignant glioma, but…
- Conditions
- Malignant Glioma, Anaplastic Astrocytoma, Anaplastic Oligoastrocytoma, Anaplastic Oligodendroglioma
- Trial name
- NCT03043391
- Testing
- Polio/Rhinovirus Recombinant (PVSRIPO)
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Istari Oncology, Inc.
Diabetes type1
A Study to Assess the Safety and Tolerability of Different Doses of AG019 Administered Alone or in Combination With Teplizumab in Participants With Recent-onset Diagnosed Type 1 Diabetes (T1D)
The purpose of this study is to assess the safety and tolerability of different doses of AG019 administered alone or in combination with teplizumab in participants with recent-onset type 1 diabetes (T1D).
- Trial name
- NCT03751007
- Testing
- AG019 - Low Dose, Teplizumab, AG019 - High Dose
- Where
- 18 sites in United States, Belgium
- Volunteers
- 45 people
- Sponsor
- Precigen Actobio T1D, LLC
Malaria
L9LS MAb in Malian Infants
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of L9LS in infants in Mali and to evaluate the impact of L9LS on subsequent R21/Matrix-MTM vaccine immunogenicity.
- Trial name
- NCT06461026
- Testing
- L9LS, R21/Matrix-MTM
- Where
- 3 sites in Mali
- Volunteers
- 327 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Hepatitis C, Chronic
Pharmacokinetics of Boceprevir in Pediatric Subjects With Chronic Hepatitis C Genotype 1 (P07614)
This is a study to determine the pharmacokinetics (PK) and weight-based dose of boceprevir following single oral dose administration in Chronic Hepatitis C Virus (HCV) pediatric participants.
- Trial name
- NCT01425190
- Testing
- Boceprevir
- Volunteers
- 16 people
- Sponsor
- Merck Sharp & Dohme LLC
T-cell Acute Lymphoblastic Leukemia, T-cell Lymphoblastic Lymphoma
A Study of LY3039478 in Combination With Dexamethasone in Participants With T-ALL/T-LBL
The main purpose of this study is to evaluate the safety of the study drug known as LY3039478 in combination with dexamethasone in participants with T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma…
- Trial name
- NCT02518113
- Testing
- LY3039478, Dexamethasone
- Where
- 22 sites in United States, France and 3 more
- Volunteers
- 36 people
- Sponsor
- Eli Lilly and Company
Suspected or Documented Gram-negative Bacterial Infection
A Pharmacokinetics Study of MK-7655A in Pediatric Participants With Gram-negative Infections (MK-7655A-020)
This study aims to obtain plasma pharmacokinetic (PK) data and characterize the PK profile of imipenem (IMI), cilastatin (CIL), and relebactam (REL) following administration of a single intravenous (IV) dose of MK-7655A (a fixed…
- Trial name
- NCT03230916
- Testing
- IMI/REL FDC
- Where
- 33 sites in United States, Bulgaria and 6 more
- Volunteers
- 47 people
- Sponsor
- Merck Sharp & Dohme LLC
Acute Lymphoblastic Leukemia (ALL)
Study of Carfilzomib in Combination With Induction Chemotherapy in Children With Relapsed or Refractory Acute Lymphoblastic Leukemia
The purpose of Phase 1b of this study is to: Asses the safety, tolerability and activity of carfilzomib, alone and in combination with induction chemotherapy, in children with relapsed or refractory acute lymphoblastic leukemia…
- Trial name
- NCT02303821
- Testing
- Carfilzomib, Dexamethasone, Mitoxantrone
- Where
- 122 sites in United States, Argentina and 31 more
- Volunteers
- 141 people
- Sponsor
- Amgen
Cystic Fibrosis
Safety/Tolerability Study of Arikayce™ in Cystic Fibrosis Patients With Chronic Infection Due to Pseudomonas Aeruginosa
This is a study to determine the safety and tolerability of 28 days of daily dosing of 560 mg of Arikayce™ versus placebo and daily dosing of 70 mg and 140 mg of Arikayce™ versus placebo in patients who have Cystic fibrosis (CF)…
- Trial name
- NCT00558844
- Testing
- Arikayce™ 560 mg, Arikayce™ 70 mg, Arikayce™ 140 mg
- Where
- 19 sites in United States
- Volunteers
- 41 people
- Sponsor
- Insmed Incorporated
Relapsed Solid Tumor, Refractory Solid Tumor
A Study of Abemaciclib (LY2835219) in Combination With Other Anti-Cancer Treatments in Children and Young Adult Participants With Solid Tumors, Including Neuroblastoma
The study's purpose is to see if the drug, abemaciclib, is safe and effective when given with other drugs to kill cancer cells. The study is open to children and young adults with solid tumors, including neuroblastoma, that did…
- Trial name
- NCT04238819
- Testing
- Abemaciclib, Irinotecan, Temozolomide
- Where
- 25 sites in United States, Australia and 6 more
- Volunteers
- 47 people
- Sponsor
- Eli Lilly and Company