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)

Status: Active

Description

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 and have come back or do not respond to treatment. PI3K / mTOR inhibitor LY3023414 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Eligibility Criteria

Inclusion Criteria

  • Patient must have enrolled onto APEC1621SC and must have been given a treatment assignment to Molecular Analysis for Therapy Choice (MATCH) to APEC1621D based on the presence of an actionable mutation; note that treatment assignment may be to primary cohort A for patients with TSC1 or TSC2 loss of function mutations, primary cohort B for patients with other PI3K/MTOR pathway mutations, a histology specific biomarker positive expansion cohort if the criteria to open such a cohort are met, or a biomarker negative expansion cohort if the criteria to open such a cohort are met
  • Patients accruing to dose level 1 must have a body surface area >= 0.52 m^2 at the time of study enrollment; patients accruing to dose level 2 must have a body surface area >= 0.37 m^2 at the time of study enrollment; patients accruing to dose level -1 must have a body surface area >= 0.75 m^2 at the time of study enrollment
  • Patients must have radiographically measurable disease at the time of study enrollment; patients with neuroblastoma who do not have measurable disease but have metaiodobenzylguanidine (MIBG) positive (+) evaluable disease are eligible; measurable disease in patients with CNS involvement is defined as tumor that is measurable in two perpendicular diameters on magnetic resonance imaging (MRI) and visible on more than one slice * Note: The following do not qualify as measurable disease: ** Malignant fluid collections (e.g., ascites, pleural effusions) ** Bone marrow infiltration except that detected by MIBG scan for neuroblastoma ** Lesions only detected by nuclear medicine studies (e.g., bone, gallium or positron emission tomography [PET] scans) except as noted for neuroblastoma ** Elevated tumor markers in plasma or cerebrospinal fluid (CSF) ** Previously radiated lesions that have not demonstrated clear progression post radiation ** Leptomeningeal lesions that do not meet the measurement requirements for Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 ** Bone lesions without an associated soft tissue mass >= 10 mm in greatest diameter; bone lesions with an associated soft tissue mass >= 10 mm in greatest diameter imaged by computed tomography (CT) or MRI are considered measurable
  • Karnofsky >= 50% for patients > 16 years of age and Lansky >= 50 for patients =< 16 years of age; Note: neurologic deficits in patients with CNS tumors must have been stable for at least 7 days prior to study enrollment; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
  • Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment; if after the required timeframe, the numerical eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately * Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive; >= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea) * Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil count [ANC] counts): >= 7 days after the last dose of agent * Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1 * Corticosteroids: if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid * Hematopoietic growth factors: >= 14 days after the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor; for growth factors that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator * Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors) * Stem cell Infusions (with or without total body irradiation [TBI]): ** Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 84 days after infusion and no evidence of graft versus host disease (GVHD) ** Autologous stem cell infusion including boost infusion: >= 42 days * Cellular therapy: >= 42 days after the completion of any type of cellular therapy (e.g. modified T cells, natural killer [NK] cells, dendritic cells, etc.) * Radiation therapy (XRT)/external beam irradiation including protons: >= 14 days after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial bone marrow (BM) radiation ** Note: radiation may not be delivered to “measurable disease” tumor site(s) being used to follow response to subprotocol treatment * Radiopharmaceutical therapy (e.g., radiolabeled antibody, iobenguane I-131 [131I-MIBG]): >= 42 days after systemically administered radiopharmaceutical therapy * Patients must not have received prior exposure to LY3023414 * Patients must not have received prior exposure to an agent specifically directed at the PI3K/MTOR pathway (a PI3K inhibitor, an AKT inhibitor, an MTOR inhibitor, including rapalogs, or a combined PI3K/MTOR inhibitor)
  • For patients with solid tumors without known bone marrow involvement: * Peripheral absolute neutrophil count (ANC) >= 1000/mm^3 * Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
  • Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood counts (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions); these patients will not be evaluable for hematologic toxicity
  • Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 ml/min/1.73 m^2 or a serum creatinine based on age/gender as follows: * Age: 1 to < 2 years; maximum serum creatinine (mg/dL): male 0.6; female 0.6 * Age: 2 to < 6 years; maximum serum creatinine (mg/dL): male 0.8; female 0.8 * Age: 6 to < 10 years; maximum serum creatinine (mg/dL): male 1; female 1 * Age: 10 to < 13 years; maximum serum creatinine (mg/dL): male 1.2; female 1.2 * Age: 13 to < 16 years; maximum serum creatinine (mg/dL): male 1.5; female 1.4 * Age: >= 16 years; maximum serum creatinine (mg/dL): male 1.7; female 1.4
  • Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age
  • Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 135 U/L; (for the purpose of this study, the ULN for SGPT is 45 U/L)
  • Serum albumin >= 2 g/dL
  • Patients must have a normal blood sugar level for age; if an initial random draw (i.e. non-fasting) blood glucose value is out of range, it is acceptable to repeat this test as a fasting draw
  • Patients must have a serum triglyceride level =< 300 mg/dL and serum cholesterol level =< 300 mg/dL; if an initial random draw (i.e. non-fasting) is out of range, it is acceptable to repeat this test as a fasting draw
  • Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled
  • Nervous system disorders (by Common Terminology Criteria for Adverse Events version 5.0 [CTCAE V 5.0]) resulting from prior therapy must be =< grade 2, with the exception of decreased tendon reflex (DTR); any grade of DTR is eligible
  • Corrected QT (QTc) interval =< 480 milliseconds
  • Patients must be able to swallow intact tablets
  • All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines

Exclusion Criteria

  • Pregnant or breast-feeding women will not be entered on this study; pregnancy tests must be obtained in girls who are post-menarchal; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while receiving study treatment and for 3 months after the last dose of LY3023414
  • Concomitant medications * Corticosteroids: patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible; if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid * Investigational drugs: patients who are currently receiving another investigational drug are not eligible * Anti-cancer agents: patients who are currently receiving other anti-cancer agents are not eligible * Anti-GVHD agents post-transplant: patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial
  • Patients who have an uncontrolled infection are not eligible
  • Patients who have insulin dependent diabetes are not eligible
  • Patients who have received a prior solid organ transplantation are not eligible
  • Patients with subependymal giant cell astrocytomas (SEGAs) are not eligible
  • Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible

Locations & Contacts

Alabama

Birmingham
Children's Hospital of Alabama
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org

Arizona

Mesa
Cardon Children's Medical Center
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org

Arkansas

Little Rock
Arkansas Children's Hospital
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org

California

Downey
Kaiser Permanente Downey Medical Center
Status: Active
Contact: Site Public Contact
Phone: 626-564-3455
Loma Linda
Loma Linda University Medical Center
Status: Active
Contact: Site Public Contact
Phone: 909-558-3375
Long Beach
Miller Children's and Women's Hospital Long Beach
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Los Angeles
Children's Hospital Los Angeles
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Madera
Valley Children's Hospital
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Oakland
Children's Hospital and Research Center at Oakland
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Kaiser Permanente-Oakland
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
San Francisco
UCSF Medical Center-Mission Bay
Status: Active
Contact: Site Public Contact
Phone: 877-827-3222

Connecticut

New Haven
Yale University
Status: Active
Contact: Site Public Contact
Phone: 203-785-5702
Email: canceranswers@yale.edu

Delaware

Wilmington
Alfred I duPont Hospital for Children
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 302-651-6884
Email: dperry@nemours.org

District of Columbia

Washington
Children's National Medical Center
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org

Florida

Gainesville
University of Florida Health Science Center - Gainesville
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Jacksonville
Nemours Children's Clinic-Jacksonville
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Miami
Nicklaus Children's Hospital
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 305-243-2647
Orlando
Arnold Palmer Hospital for Children
Status: Active
Contact: Site Public Contact
Phone: 321-843-2584
Email: melissa.leffin@orlandohealth.com
Nemours Children's Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Saint Petersburg
Johns Hopkins All Children's Hospital
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Tampa
Saint Joseph's Hospital / Children's Hospital-Tampa
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org

Georgia

Atlanta
Children's Healthcare of Atlanta - Egleston
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org

Idaho

Boise
Saint Luke's Mountain States Tumor Institute
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org

Illinois

Chicago
University of Chicago Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 773-702-8222
Email: cancerclinicaltrials@bsd.uchicago.edu
Peoria
Saint Jude Midwest Affiliate
Status: Active
Contact: Site Public Contact
Phone: 888-226-4343

Indiana

Indianapolis
Riley Hospital for Children
Status: Active
Contact: Site Public Contact
Phone: 800-248-1199

Iowa

Des Moines
Blank Children's Hospital
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-237-1225

Kentucky

Louisville
Norton Children's Hospital
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org

Louisiana

New Orleans
Ochsner Medical Center Jefferson
Status: Active
Contact: Site Public Contact
Phone: 504-703-8712
Email: Gregory.Johnstone@ochsner.org

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 410-955-8804
Email: jhcccro@jhmi.edu
Sinai Hospital of Baltimore
Status: Active
Contact: Site Public Contact
Phone: 410-601-6120
Email: pridgely@lifebridgehealth.org

Michigan

Ann Arbor
C S Mott Children's Hospital
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org

Minnesota

Minneapolis
Children's Hospitals and Clinics of Minnesota - Minneapolis
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
University of Minnesota / Masonic Cancer Center
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Rochester
Mayo Clinic
Status: Active
Contact: Site Public Contact
Phone: 855-776-0015

Mississippi

Jackson
University of Mississippi Medical Center
Status: Active
Contact: Site Public Contact
Phone: 601-815-6700

Missouri

Kansas City
The Childrens Mercy Hospital
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Saint Louis
Mercy Hospital Saint Louis
Status: Active
Contact: Site Public Contact
Phone: 314-251-6770
Washington University School of Medicine
Status: Active
Contact: Site Public Contact
Phone: 800-600-3606
Email: info@siteman.wustl.edu

Nebraska

Omaha
Children's Hospital and Medical Center of Omaha
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
University of Nebraska Medical Center
Status: Active
Contact: Site Public Contact
Phone: 402-559-6941
Email: unmcrsa@unmc.edu

Nevada

Las Vegas
Alliance for Childhood Diseases / Cure 4 the Kids Foundation
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
Summerlin Hospital Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
Sunrise Hospital and Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
University Medical Center of Southern Nevada
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org

New Jersey

Hackensack
Hackensack University Medical Center
Status: Active
Contact: Site Public Contact
Phone: 201-996-2879

New York

Buffalo
Roswell Park Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 800-767-9355
Email: askroswell@roswellpark.org
New Hyde Park
The Steven and Alexandra Cohen Children's Medical Center of New York
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
New York
Columbia University / Herbert Irving Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 212-305-6361
Email: nr2616@cumc.columbia.edu
Memorial Sloan Kettering Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 212-639-7592
Rochester
University of Rochester
Status: Active
Contact: Site Public Contact
Phone: 585-275-5830
Syracuse
State University of New York Upstate Medical University
Status: Active
Contact: Site Public Contact
Phone: 315-464-5476

North Carolina

Asheville
Mission Hospital Inc-Memorial Campus
Status: Active
Contact: Site Public Contact
Phone: 828-213-4150
Email: leslie.verner@msj.org
Durham
Duke University Medical Center
Status: Active
Contact: Site Public Contact
Phone: 888-275-3853

Ohio

Cincinnati
Cincinnati Children's Hospital Medical Center
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Cleveland
Cleveland Clinic Foundation
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 866-223-8100
Email: CancerAnswer@ccf.org
Columbus
Nationwide Children's Hospital
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Dayton
Dayton Children's Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Toledo
The Toledo Hospital / Toledo Children's Hospital
Status: Active
Contact: Site Public Contact
Phone: 419-824-1842

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: Active
Contact: Site Public Contact
Phone: 405-271-8777
Email: ou-clinical-trials@ouhsc.edu

Oregon

Portland
Legacy Emanuel Children's Hospital
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Oregon Health and Science University
Status: Active
Contact: Site Public Contact
Phone: 503-494-1080
Email: trials@ohsu.edu

Pennsylvania

Philadelphia
Children's Hospital of Philadelphia
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Pittsburgh
Children's Hospital of Pittsburgh of UPMC
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org

Puerto Rico

San Juan
San Jorge Children's Hospital
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org

South Carolina

Greenville
BI-LO Charities Children's Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org

South Dakota

Sioux Falls
Sanford USD Medical Center - Sioux Falls
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 605-312-3320
Email: OncologyClinicalTrialsSF@SanfordHealth.org

Tennessee

Knoxville
East Tennessee Childrens Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 865-541-8266
Memphis
St. Jude Children's Research Hospital
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Nashville
Vanderbilt University / Ingram Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-811-8480

Texas

Austin
Dell Children's Medical Center of Central Texas
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Dallas
Medical City Dallas Hospital
Status: Active
Contact: Site Public Contact
Phone: 972-566-5588
UT Southwestern / Simmons Cancer Center-Dallas
Status: Active
Contact: Site Public Contact
Phone: 214-648-7097
Email: canceranswerline@UTSouthwestern.edu
Fort Worth
Cook Children's Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Houston
Baylor College of Medicine / Dan L Duncan Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 713-798-1354
Email: burton@bcm.edu
San Antonio
Children's Hospital of San Antonio
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Methodist Children's Hospital of South Texas
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
University of Texas Health Science Center at San Antonio
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 210-450-3800
Email: phoresearchoffice@uthscsa.edu

Virginia

Norfolk
Children's Hospital of The King's Daughters
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Richmond
Virginia Commonwealth University / Massey Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: mwellons@vcu.edu

Washington

Seattle
Seattle Children's Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Spokane
Providence Sacred Heart Medical Center and Children's Hospital
Status: Active
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Tacoma
Madigan Army Medical Center
Status: Active
Contact: Site Public Contact
Phone: 253-968-0129
Email: mamcdci@amedd.army.mil

West Virginia

Morgantown
West Virginia University Healthcare
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 304-293-7374
Email: cancertrialsinfo@hsc.wvu.edu

Wisconsin

Madison
University of Wisconsin Hospital and Clinics
Status: Active
Contact: Site Public Contact
Phone: 800-622-8922
Milwaukee
Children's Hospital of Wisconsin
Status: Active
Contact: Site Public Contact
Phone: 414-955-4727
Email: MACCCTO@mcw.edu

Trial Objectives and Outline

PRIMARY OBJECTIVES:

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.

TERTIARY 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. Courses 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.

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
Childrens Oncology Group

Principal Investigator
Theodore Willis Laetsch

Trial IDs

Primary ID APEC1621D
Secondary IDs NCI-2017-01249
Clinicaltrials.gov ID NCT03213678