Last updated on July 2020

PI3K/mTOR Inhibitor LY3023414 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)


Brief description of study

This phase II Pediatric MATCH trial studies how well PI3K/mTOR inhibitor LY3023414 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). PI3K/mTOR inhibitor LY3023414 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Detailed Study Description

PRIMARY OBJECTIVE:

I. To determine the objective response rate (ORR; complete response + partial response) in pediatric patients treated with PI3K/mTOR inhibitor LY3023414 (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 PI3K/mTOR inhibitor LY3023414 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.

Clinical Study Identifier: NCT03213678

Find a site near you

Start Over

Sinai Hospital of Baltimore

Baltimore, MD United States
  Connect »

Kaiser Permanente-Oakland

Oakland, CA United States
  Connect »

Ochsner Medical Center Jefferson

New Orleans, LA United States
  Connect »

Children's Hospital of Alabama

Birmingham, AL United States
  Connect »

Arkansas Children's Hospital

Little Rock, AR United States
  Connect »

Children's Hospital Los Angeles

Los Angeles, CA United States
  Connect »

Mattel Children's Hospital UCLA

Los Angeles, CA United States
  Connect »

Yale University

New Haven, CT United States
  Connect »

Nemours Children's Hospital

Orlando, FL United States
  Connect »

Johns Hopkins All Children's Hospital

Saint Petersburg, FL United States
  Connect »

Blank Children's Hospital

Des Moines, IA United States
  Connect »

Norton Children's Hospital

Louisville, KY United States
  Connect »

Children's Hospital New Orleans

New Orleans, LA United States
  Connect »

C S Mott Children's Hospital

Ann Arbor, MI United States
  Connect »

Geisinger Medical Center

Danville, PA United States
  Connect »

Cook Children's Medical Center

Fort Worth, TX United States
  Connect »

Seattle Children's Hospital

Seattle, WA United States
  Connect »

Primary Children's Hospital

Salt Lake City, UT United States
  Connect »

M D Anderson Cancer Center

Houston, TX United States
  Connect »

AdventHealth Orlando

Orlando, FL United States
  Connect »

Mission Hospital

Asheville, NC United States
  Connect »

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


Volunteer Sign-up

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.