Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Advanced Malignant Solid Neoplasm
  • Ann Arbor Stage III Non-Hodgkin Lymphoma
  • Ann Arbor Stage IV Non-Hodgkin Lymphoma
  • Recurrent Medulloblastoma
  • Malignant Glioma
  • Recurrent Neuroblastoma
  • Recurrent Soft Tissue Sarcoma
  • Recurrent Primary Central Nervous System Neoplasm
  • Recurrent Ependymoma
  • Recurrent Ewing Sarcoma
  • Recurrent Osteosarcoma
  • Stage III Osteosarcoma AJCC v7
  • Stage IVA Osteosarcoma AJCC v7
  • Wilm's Tumor
  • Recurrent Glioma
  • Refractory Primary Central Nervous System Neoplasm
  • Stage IV Osteosarcoma AJCC v7
  • Recurrent Rhabdomyosarcoma
  • Rhabdoid Tumor
  • Refractory Neuroblastoma
  • Refractory Malignant Solid Neoplasm
  • Recurrent Non-Hodgkin Lymphoma
  • Recurrent Peripheral Primitive Neuroectodermal Tumor
  • Refractory Non Hodgkin Lymphoma
  • Stage III Soft Tissue Sarcoma AJCC v7
  • Recurrent Hepatoblastoma
  • Refractory Langerhans Cell Histiocytosis
  • Stage IVB Osteosarcoma AJCC v7
  • Recurrent Langerhans Cell Histiocytosis
  • Recurrent Malignant Germ Cell Tumor
  • Recurrent Malignant Solid Neoplasm
  • Stage IV Soft Tissue Sarcoma AJCC v7
  • Refractory Malignant Germ Cell Tumor
Type
Interventional
Phase
Phase 2
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Younger than 1221 years
Gender
Both males and females

Description

PRIMARY OBJECTIVE: I. To determine the objective response rate (ORR; complete response + partial response) in pediatric patients treated with samotolisib (LY3023414) with advanced solid tumors, non-Hodgkin lymphomas or central nervous system (CNS) tumors that harbor TSC loss of function mutations, t...

PRIMARY OBJECTIVE: I. To determine the objective response rate (ORR; complete response + partial response) in pediatric patients treated with samotolisib (LY3023414) with advanced solid tumors, non-Hodgkin lymphomas or central nervous system (CNS) tumors that harbor TSC loss of function mutations, that harbor other PI3K/MTOR activating mutations, and if efficacy is observed in a MATCHed cohort, in patients that lack mutations in the PI3K/MTOR pathway. SECONDARY OBJECTIVES: I. To estimate the progression free survival in pediatric patients treated with LY3023414 with advanced solid tumors, non-Hodgkin lymphomas or CNS tumors that harbor TSC loss of function mutations, that harbor other PI3K/MTOR activating mutations, or if efficacy is observed in a MATCHed cohort, that lack mutations in the PI3K/MTOR pathway. II. To obtain information about the tolerability of LY3023414 in children with relapsed or refractory cancer. III. To characterize the pharmacokinetics of LY3023414 in children with recurrent or refractory cancer. IV. If efficacy is observed in a MATCHed cohort, to obtain preliminary information on the response rate to LY3023414 in patients that lack mutations in the PI3K/MTOR pathway. EXPLORATORY OBJECTIVES: I. To increase knowledge of the genomic landscape of relapsed pediatric solid tumors and lymphomas and identify potential predictive biomarkers (other than the genomic alteration for which study treatment was assigned) using additional genomic, transcriptomic, and proteomic testing platforms. II. To explore approaches to profiling changes in tumor genomics over time through evaluation of circulating tumor deoxyribonucleic acid (DNA). III. To evaluate the frequency and mechanism of biallelic loss of function, and evaluate the expression of TSC1, TSC2, and PTEN in subjects who enroll with a loss of function mutation in one of these genes. OUTLINE: This is a dose-escalation study. Patients receive samotolisib orally (PO) twice daily (BID) on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unexpected toxicity. After completion of study treatment, patients are followed up periodically.

Tracking Information

NCT #
NCT03213678
Collaborators
Not Provided
Investigators
Principal Investigator: Theodore W Laetsch Children's Oncology Group