List of Studies
Rare Tumors |
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Phase 2 Trial of XL184 AYA age 2-30 (except MTC, RCC, HCC upper age 18) |
Relapsed/refractory or newly diagnosed with no known curative therapy:
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Relapsed/refractory Juvenile Myelomonocytic Leukemia |
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A Phase 2 Study of the MEK inhibitor Trametinib (IND#119346, NSC#763093) in Children with Relapsed or Refractory Juvenile Myelomonocytic Leukemia (ages ≥ 2 years to < 22) | ||
Upfront Therapy Neuro-oncology |
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Head Start 4 | Newly Diagnosed Children (<10 Years Old) With Medulloblastoma And Other Central Nervous System Embryonal Tumors. Clinical And Molecular Risk-Tailored Intensive And Compressed Induction Chemotherapy Followed By Consolidation With Randomization To Either Single-Cycle Or To Three Tandem Cycles Of Marrow-Ablative Chemotherapy With Autologous Hematopoietic Progenitor Cell Rescue (less than 10 years of age) | |
ADVL1217 | A Phase 1 Study of AZD1775 (MK-1775, IND#116459) Concurrent with Local Radiation Therapy for the Treatment of Newly Diagnosed Children with Diffuse Intrinsic Pontine Gliomas (> than 36 months to ≤ 21 years) | |
Relapsed/Refractory Neuro-oncology |
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UAB1472 | Phase I Clinical Trial of HSV G207 Alone or with a Single Radiation Dose in Children with Recurrent Supratentorial Brain Tumors (≥ 36 months to < 19 years) | |
ADVL1414 | A Phase 1 Study of Selinexor (KPT-330, IND #125052), a Selective XPO1 Inhibitor, in Recurrent and Refractory Pediatric Solid Tumors, including CNS Tumors (≥ than 12 months to ≤ 21 years) | |
ADVL1416 | A Phase 1 study of Ramucirumab, a Human Monoclonal Antibody Against the Vascular Endothelial Growth Factor-2 (VEGFR-2) Receptor in Children with Refractory Solid tumors, including CNS Tumors (≥ 12 months to ≤ 21 years) | |
ADVL1513 | A Phase 1 Study of entinostat, an oral histone deacetylase inhibitor, in Pediatric Patients with Recurrent or Refractory Solid Tumors, including CNS Tumors and Lymphoma (≥ than 12 months to ≤ 21 years) | |
ADVL1514 | A Phase 1 Study of ABI-009 (nab-Rapamycin) in Pediatric Patients with Recurrent or Refractory Solid Tumors, Including CNS Tumors as a Single Agent and in Combination with Temozolomide and Irinotecan (≥ 12 months to ≤ 21 years) | |
ADVL1515 | A Phase 1 Study of LY2606368, a CHK1/2 inhibitor, in Pediatric Patients with Recurrent or Refractory Solid Tumors, including CNS Tumors (≥ than 12 months to ≤ 21 years) | |
ADVL1615 | A Phase 1 Study of Pevonedistat (MLN4924, IND# 136078), a NEDD8 Activating Enzyme (NAE) Inhibitor, in Combination with Temozolomide and Irinotecan in Pediatric Patients with Recurrent or Refractory Solid Tumors (≥ 6 months to < 21 years) | |
ADVL1711 | A Phase 1/2 Study of Lenvatinib in Combination With Everolimus in Recurrent and Refractory Pediatric Solid Tumors, Including CNS Tumors (≥2 years to ≤21 years for phase 2) | |
MEK162 | Phase I-II Study of MEK162 for Children with Low Grade Gliomas and Other Ras/Raf/ERK Pathway Activated Tumors (>1 year to <18 years) |
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Relapsed/Refractory Solid tumors |
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ADVL1412 | A Phase 1/2 Study of Nivolumab (IND#124729) in Children, Adolescents, and Young Adults with Recurrent or Refractory Solid Tumors as a Single Agent and in Combination with Ipilimumab (≥ 12 months to ≤ 30 years depending on strata) | |
ADVL1414 | A Phase 1 Study of Selinexor (KPT-330, IND #125052), a Selective XPO1 Inhibitor, in Recurrent and Refractory Pediatric Solid Tumors, including CNS Tumors (≥ than 12 months to ≤ 21 years) | |
ADVL1416 | A Phase 1 study of Ramucirumab, a Human Monoclonal Antibody Against the Vascular Endothelial Growth Factor-2 (VEGFR-2) Receptor in Children with Refractory Solid tumors, including CNS Tumors (≥ 12 months to ≤ 21 years) | |
ADVL1513 | A Phase 1 Study of entinostat, an oral histone deacetylase inhibitor, in Pediatric Patients with Recurrent or Refractory Solid Tumors, including CNS Tumors and Lymphoma (≥ than 12 months to ≤ 21 years) | |
ADVL1514 | A Phase 1 Study of ABI-009 (nab-Rapamycin) in Pediatric Patients with Recurrent or Refractory Solid Tumors, Including CNS Tumors as a Single Agent and in Combination with Temozolomide and Irinotecan (≥ 12 months to ≤ 21 years) | |
ADVL1515 | A Phase 1 Study of LY2606368, a CHK1/2 inhibitor, in Pediatric Patients with Recurrent or Refractory Solid Tumors, including CNS Tumors (≥ than 12 months to ≤ 21 years) | |
ADVL1614 | A Phase 1/2 Study of VX15/2503 (IND# 136181) in Children, Adolescents, or Young Adults with Recurrent or Relapsed Solid Tumors (≥ 12 months to ≤ 30 years depending on strata) | |
ADVL1615 | A Phase 1 Study of Pevonedistat (MLN4924, IND# 136078), a NEDD8 Activating Enzyme (NAE) Inhibitor, in Combination with Temozolomide and Irinotecan in Pediatric Patients with Recurrent or Refractory Solid Tumors (≥ 6 months to < 21 years) | |
ADVL1622 | Phase 2 Trial of XL184 (Cabozantinib) an Oral Small-Molecule Inhibitor of Multiple Kinases, in Children and Young Adults with Refractory Sarcomas, Wilms Tumor, and Other Rare Tumors (≥ 2 to ≤ 30 years depending on strata) | |
ADVL1711 | A Phase 1/2 Study of Lenvatinib in Combination With Everolimus in Recurrent and Refractory Pediatric Solid Tumors, Including CNS Tumors (≥2 years to <18 years for phase 1; ≥2 years to ≤21 years for phase 2) |
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ADVL1722 | A Phase 2, multicenter, open-label study to assess safety and preliminary activity of eribulin mesylate in pediatric subjects with relapsed/refractory rhabdomyosarcoma (RMS), nonrhabdomyosarcoma soft tissue sarcoma (NRSTS) and Ewing sarcoma (EWS) (≥12 months to | |
ADVL1721 | A non-randomized, open-label, multi-center, Phase I/II study of PI3K inhibitor copanlisib in pediatric patients with relapsed/refractory solid tumors or lymphoma (6 months to ≤ 21 years) | |
Neuroblastoma |
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NMTRC012 | A Study Using Molecular Guided Therapy with Induction Chemotherapy followed by a Randomized Controlled Trial of standard immunotherapy with or without DFMO followed by DFMO maintenance for Subjects with Newly Diagnosed High-Risk Neuroblastoma (≤ 21 years at initial diagnosis) | |
NMTRC014 |
Neuroblastoma Maintenance Therapy Trial Using Difluoromethylornithine (DFMO)(≤ 30.99 years of age)
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ADVL1312 | A Phase 1/2 Study of AZD1775 (MK-1775, IND# 121422) in Combination with Oral Irinotecan in Children, Adolescents, and Young Adults with Relapsed or Refractory Solid Tumors (> than 12 months to ≤ 21 years) | |
Lymphoma |
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ADVL1513 | A Phase 1 Study of entinostat, an oral histone deacetylase inhibitor, in Pediatric Patients with Recurrent or Refractory Solid Tumors, including CNS Tumors and Lymphoma (≥ than 12 months to ≤ 21 years) | |
ADVL1615 | A Phase 1 Study of Pevonedistat (MLN4924, IND# 136078), a NEDD8 Activating Enzyme (NAE) Inhibitor, in Combination with Temozolomide and Irinotecan in Pediatric Patients with Recurrent or Refractory Solid Tumors (≥ 6 months to < 21 years) | |
ADVL1721 | A non-randomized, open-label, multi-center, Phase I/II study of PI3K inhibitor copanlisib in pediatric patients with relapsed/refractory solid tumors or lymphoma (6 months to ≤ 21 years) | |
Molecularly Targeted Agents |
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APEC1621A pan-TRK inhibitor |
Phase 2 study of LOXO-101 (Larotrectinib) in patients with tumors harboring NTRK fusions. | |
APEC1621B FGFR inhibitor |
Phase 2 study of JNJ-42756493 (Erdafitinib) in patients with tumors harboring FGFR alterations | |
APEC1621C EZH2 inhibitor |
Phase 2 study of Tazemetostat in patients with tumors harboring alterations in EZH2 or members of the SWI/SNF complex | |
APEC1621D PI3K/mTOR |
Phase 2 study of LY3023414 in patients with solid tumors | |
APEC1621E MEK inhibitor |
Phase 2 study of Selumetinib in patients with tumors harboring activating MAPK pathway mutations | |
APEC1621F ALK inhibitor |
Phase 2 study of Ensartinib in patients with tumors harboring ALK or ROS1 genomic alterations | |
APEC1621G BRAF inhibitor |
Phase 2 study of Vemurafenib in patients with tumors harboring BRAF V600 mutations | |
APEC1621H PARP inhibitor |
Phase 2 study of Olaparib in patients with tumors harboring defects in DNA damage repair genes | |
APEC1621I CDK 4/6 inhibitor |
Phase 2 subprotocol of Palbociclib in Patients with Tumors Harboring Activating Alterations in Cell Cycle Genes | |
APEC1621J ERK 1/2 Inhibitor |
Phase 2 Subprotocol of BVD-523FB (ulixertinib) in Patients with Tumors Harboring Activating MAPK Pathway Mutations | |
MEK162 MEK inhibitor |
Phase I-II Study of MEK162 for Children with Low Grade Gliomas and Other Ras/Raf/ERK Pathway Activated Tumors | |
NMTRC012 | A Study Using Molecular Guided Therapy with Induction Chemotherapy followed by a Randomized Controlled Trial of standard immunotherapy with or without DFMO followed by DFMO maintenance for Subjects with Newly Diagnosed High-Risk Neuroblastoma | |