Clinical Trials Directory

Trials / Completed

CompletedNCT03213678

Samotolisib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With TSC or PI3K/MTOR Mutations (A Pediatric MATCH Treatment Trial)

NCI-COG Pediatric MATCH (Molecular Analysis For Therapy Choice)- Phase 2 Subprotocol of LY3023414 in Patients With Solid Tumors

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
18 (actual)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
All
Age
12 Months – 21 Years
Healthy volunteers
Not accepted

Summary

This phase II Pediatric MATCH trial studies how well samotolisib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with TSC or PI3K/MTOR mutations that have spread to other places in the body (metastatic) and have come back (recurrent) or do not respond to treatment (refractory). Samotolisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Detailed 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, and/or other PI3K/MTOR activating mutations. 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, and/or other PI3K/MTOR activating mutations. 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. 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. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unexpected toxicity. Patients undergo an x-ray, computed tomography (CT), magnetic resonance imaging (MRI), fludeoxyglucose F-18 (FDG)-position emission tomography (FDG-PET), and blood sample collection on study. After completion of study treatment, patients are followed up periodically.

Conditions

Interventions

TypeNameDescription
PROCEDUREBiospecimen CollectionUndergo blood specimen collection
PROCEDUREComputed TomographyUndergo CT
PROCEDUREFDG-Positron Emission TomographyUndergo FDG-PET
PROCEDUREMagnetic Resonance ImagingUndergo MRI
DRUGSamotolisibGiven PO
PROCEDUREX-Ray ImagingUndergo x-ray

Timeline

Start date
2017-11-28
Primary completion
2023-09-30
Completion
2024-12-31
First posted
2017-07-11
Last updated
2026-04-02
Results posted
2024-09-04

Locations

127 sites across 2 countries: United States, Puerto Rico

Regulatory

Source: ClinicalTrials.gov record NCT03213678. Inclusion in this directory is not an endorsement.