Print  |  Close

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)


Active: No
Cancer Type: Brain & Spinal Cord Tumor
Brain Tumor
Liver Cancer / Hepatoblastoma
Neuroblastoma
Non-Hodgkin Lymphoma
Sarcoma
Wilms Tumor
NCT ID: NCT03213678
Trial Phases: Phase II Protocol IDs: APEC1621D (primary)
NCI-2017-01249
APEC1621D
APEC1621D
Eligibility: 12 Months - 21 Years, Male and Female Study Type: Treatment
Study Sponsor: Children's Oncology Group
NCI Full Details: http://clinicaltrials.gov/show/NCT03213678

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.

Objectives

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.

Treatment Sites in Georgia

Curtis and Elizabeth Anderson Cancer Institute at Memorial University Medical Center
4700 Waters Avenue
Savannah, GA 31404
912-350-8913
www.memorialhealth.com/anderson-cancer-institute.aspx

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.