Clinical trials: Pediatric Oncology
Refractory Ewing Sarcoma, Relapsed Ewing Sarcoma
Study of Lurbinectedin Monotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Ewing Sarcoma
This study is conducted in two phases. The phase 1 portion of the study evaluates the safety, tolerability, pharmacokinetics (PK), recommended phase 2 dose (RP2D), and effectiveness of lurbinectedin monotherapy in pediatric…
- Conditions
- Refractory Ewing Sarcoma, Relapsed Ewing Sarcoma, Ewing Sarcoma
- Trial name
- NCT05734066
- Testing
- Lurbinectedin
- Where
- 15 sites in United States, Canada
- Volunteers
- 60 people
- Sponsor
- Jazz Pharmaceuticals
Lymphoma, Non-Hodgkin, Hodgkin Disease
A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of Relatlimab Plus Nivolumab in Pediatric and Young Adults With Hodgkin and Non-Hodgkin Lymphoma
The purpose of this study is to assess the safety, tolerability, drug levels, and preliminary efficacy of relatlimab plus nivolumab in pediatric and young adult participants with recurrent or refractory classical Hodgkin lymphoma…
- Trial name
- RELATIVITY-069 (NCT05255601)
- Testing
- Relatlimab, Nivolumab
- Where
- 51 sites in United States, Australia and 5 more
- Volunteers
- 5 people
- Sponsor
- Bristol-Myers Squibb
Acute Lymphocytic Leukemia
A Study to Learn About the Safety of BESPONSA Injection in Pediatric Patients With Acute Lymphocytic Leukemia.
The purpose of this study is to learn about the safety of BESPONSA for pediatric patients. . BESPONSA is approved for treatment of relapsed or refractory CD22-positive acute lymphocytic leukemia for pediatric patients.
- Trial name
- NCT06476665
- Where
- Japan
- Volunteers
- 12 people
- Sponsor
- Pfizer
Synovial Sarcoma
CAMPFIRE: A Study of Ramucirumab (LY3009806) in Children and Young Adults With Synovial Sarcoma
This study is being conducted to test the safety and efficacy of ramucirumab in combination with other chemotherapy in the treatment of relapsed, recurrent, or refractory synovial sarcoma (SS) in children and young adults.
- Trial name
- NCT04145700
- Testing
- Ramucirumab, Gemcitabine, Docetaxel
- Where
- 56 sites in United States, Australia and 8 more
- Volunteers
- 23 people
- Sponsor
- Eli Lilly and Company
Neurofibromatosis 1, Plexiform Neurofibroma
Study to Evaluate the Safety, Tolerability, PK Characteristics and Anti-tumor Activity of FCN-159 in Adult and Pediatric Participants With Neurofibromatosis Type 1
FCN-159 is a highly active MEK1/2 inhibitor that was designed, synthesized and screened on the basis of the structure of trametinib.
- Conditions
- Neurofibromatosis 1, Plexiform Neurofibroma, NF1
- Trial name
- NCT04954001
- Testing
- FCN-159
- Where
- 14 sites in United States, China and 1 more
- Volunteers
- 160 people
- Sponsor
- Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
Diffuse Intrinsic Pontine Glioma, Glioma, Malignant
ONC201 in Pediatric H3 K27M Gliomas
This was a Phase 1, open label, multicenter, 8-arm, dose escalation study of dordaviprone (ONC201) in pediatric patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG) and recurrent/refractory H3 K27M-mutant…
- Trial name
- NCT03416530
- Testing
- Dordaviprone (ONC201)
- Where
- 8 sites in United States
- Volunteers
- 134 people
- Sponsor
- Jazz Pharmaceuticals
Solid Tumors
Safety and Pharmacokinetics of Cobimetinib in Pediatric and Young Adult Participants With Previously Treated Solid Tumors
This open-label, dose-escalation study is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of cobimetinib in pediatric and young adult participants with solid tumors with known or…
- Trial name
- iMATRIXcobi (NCT02639546)
- Testing
- Cobimetinib
- Where
- 17 sites in United States, France and 5 more
- Volunteers
- 56 people
- Sponsor
- Hoffmann-La Roche
Brain Tumor
Blood Brain Barrier (BBB) Disruption Using Exablate Focused Ultrasound With Doxorubicin for Treatment of Pediatric DIPG
The purpose of this study is to evaluate the safety and efficacy of targeted blood brain barrier disruption with Exablate Model 4000 Type 2.0/2.1 in combination with Doxorubicin therapy for the treatment of DIPG in pediatric…
- Trial name
- NCT05615623
- Testing
- Exablate, Doxorubicin
- Where
- Canada
- Volunteers
- 10 people
- Sponsor
- InSightec
Medulloblastoma, Childhood, Rhabdomyosarcoma
A Study of LY2940680 in Pediatric Medulloblastoma or Rhabdomyosarcoma
The purpose of this study is to find a recommended dose level of LY2940680 that can be safely given to children with medulloblastoma or rhabdomyosarcoma that has returned or doesn't respond to initial treatment.
- Trial name
- NCT01697514
- Testing
- LY2940680
- Where
- 4 sites in United States
- Sponsor
- Eli Lilly and Company
Myasthenia Gravis
A Study of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis
The purpose of this study is to determine the effect of nipocalimab on total serum immunoglobulin G (IgG) in pediatric participants 2 to less than (<) 18 years of age (globally) and 8 to <18 years of age (for Unites Stated (US)…
- Trial name
- NCT05265273
- Testing
- Nipocalimab
- Where
- 19 sites in United States, Japan and 2 more
- Volunteers
- 12 people
- Sponsor
- Janssen Research & Development, LLC
Hepatitis C Virus Infection
Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed Dose Combination in the Treatment of Hepatitis C Virus (HCV) Infection in Pediatric Participants Undergoing Cancer Chemotherapy
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) in treating hepatitis C virus (HCV) infection in pediatric participants who are undergoing cancer…
- Trial name
- NCT02868242
- Testing
- LDV/SOF
- Where
- Egypt
- Volunteers
- 19 people
- Sponsor
- Gilead Sciences
Neuroblastoma, Rhabdomyosarcoma
Enoblituzumab (MGA271) in Children With B7-H3-expressing Solid Tumors
This study is a Phase 1, open-label, dose escalation and cohort expansion trial designed to characterize the safety, tolerability, PK, PD, immunogenicity and preliminary antitumor activity of enoblituzumab administered IV on a…
- Conditions
- Neuroblastoma, Rhabdomyosarcoma, Osteosarcoma, Ewing Sarcoma
- Trial name
- NCT02982941
- Testing
- Enoblituzumab
- Where
- 6 sites in United States
- Volunteers
- 25 people
- Sponsor
- MacroGenics
Neuroectodermal Tumors, Rhabdomyosarcoma
Trial of Afatinib in Pediatric Tumours
Open-label, dose escalation, monotherapy, basket trial with biomarker specific MTD expansion cohort/Phase II part. The trial will consist of 2 parts: 1. Dose finding part to determine the MTD 2.
- Trial name
- NCT02372006
- Testing
- afatinib
- Where
- 28 sites in United States, Australia and 10 more
- Volunteers
- 56 people
- Sponsor
- Boehringer Ingelheim
Neuroblastoma
Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor (GMCSF) and Isotretinoin for Consolidation of Patients With High-Risk Neuroblastoma in First Remission.
This is a single-arm, uncontrolled, international, multi-center, clinical,phase 2 trial, in patients ≥ 12 months of age with high-risk neuroblastoma in first remission.
- Trial name
- NCT04909515
- Testing
- Naxitamab, GM-CSF, Isotretinoin
- Where
- 9 sites in Hong Kong, Russia and 2 more
- Sponsor
- Y-mAbs Therapeutics
Pediatrics, Solid Tumors
This is a Phase 1 Study of Eribulin Mesylate in Pediatric Participants With Recurrent or Refractory Solid Tumors (Excluding [Central Nervous System] CNS), Including Lymphomas
This is a Phase 1 study of eribulin mesylate in pediatric participants with recurrent or refractory solid tumors (excluding CNS), including lymphomas.
- Trial name
- BOLD 113 (NCT02171260)
- Testing
- Eribulin Mesylate
- Where
- 18 sites in United States
- Volunteers
- 23 people
- Sponsor
- Eisai Inc.
Neurogenic Detrusor Overactivity
Open-label, Long-term Safety, Efficacy, and Pharmacokinetics Study of Vibegron in Pediatric Subjects 2 Years to < 18 Years of Age With NDO and on CIC
The purpose of this study is to evaluate the safety, efficacy, and PK of Vibegron in pediatric participants with NDO who are regularly using CIC
- Trial name
- KANGUROO (NCT05491525)
- Testing
- Vibegron
- Where
- 38 sites in United States, Belgium and 14 more
- Volunteers
- 71 people
- Sponsor
- Urovant Sciences GmbH
Low-grade Glioma, Advanced Solid Tumor
A Study to Evaluate Tovorafenib in Pediatric and Young Adult Participants With Relapsed or Progressive Low-Grade Glioma and Advance Solid Tumors
This is a Phase 2, multi center, open-label study to evaluate the safety and efficacy of Type II RAF (tovorafenib) in pediatric participants with low-grade glioma or advanced solid tumors.
- Trial name
- FIREFLY-1 (NCT04775485)
- Testing
- Tovorafenib
- Where
- 35 sites in United States, Australia and 9 more
- Volunteers
- 141 people
- Sponsor
- Day One Biopharmaceuticals, Inc.
Parenteral Nutrition Associated Liver Disease, Essential Fatty Acid Deficiency
Safety of Omegaven in Pediatric Patients With Parenteral Nutrition-Associated Cholestasis (PNAC)
This study will demonstrate Short-, mid-, and long-term safety in pediatric patients with Parenteral Nutrition-Associated Cholestasis treated with Omegaven®, which is indicated as a source of calories and fatty acids in this…
- Conditions
- Parenteral Nutrition Associated Liver Disease, Essential Fatty Acid Deficiency, Neurocognitive Deficit, Malnutrition
- Trial name
- NCT04807478
- Testing
- Omegaven® (fish oil triglycerides) Injectable Emulsion
- Sponsor
- Fresenius Kabi
Nutritional and Metabolic Diseases
Rasburicase for Hyperuricemia
Primary: To estimate efficacy of SR29142 to the pediatric patients with newly diagnosed hematological malignancies at high risk for Tumor Lysis Syndrome, by evaluation of plasma uric acid concentration.
- Trial name
- NCT00290992
- Testing
- rasburicase (SR29142)
- Where
- Japan
- Volunteers
- 30 people
- Sponsor
- Sanofi
Relapsed/Refractory Acute Myeloid Leukemia
Safety and Efficacy of NK520 to Treat Pediatric Relapsed/Refractory Acute Myeloid Leukemia
This study will evaluate the safety and efficacy of NK520 in the treatment of pediatric relapsed/refractory acute myeloid leukemia. NK520 will be administered by intravenous injection.
- Trial name
- NCT06541405
- Testing
- NK520
- Where
- China
- Volunteers
- 2 people
- Sponsor
- Base Therapeutics (Shanghai) Co., Ltd.