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Patients receive samotolisib PO 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, CT, MRI, FDG-PET, and blood sample collection on study.

Biospecimen Collection

Computed Tomography

FDG-Positron Emission Tomography

Magnetic Resonance Imaging

Samotolisib

X-Ray Imaging

Theodore W Laetsch

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.

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.

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

A descriptive analysis will be performed and will be summarized with simple summary statistics. All of these analyses will be descriptive in nature.

Response rates will be calculated as the percent of evaluable patients who are responders, and confidence intervals will be constructed using the Wilson score interval method.

Will be graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Any eligible patient who receives at least one dose of protocol therapy will be considered in the evaluation of toxicity.

PFS along with the confidence intervals will be estimated using the Kaplan-Meier method.

A descriptive analysis of pharmacokinetic (PK) parameters will be performed to define systemic exposure, drug clearance, and other pharmacokinetic parameters. The PK parameters will be summarized with simple summary statistics, including means, medians, ranges, and standard deviations (if numbers and distribution permit).

National Cancer Institute (NCI)

Xanthogranuloma, Juvenile

Histiocytic Sarcoma

Histiocytic Disorders, Malignant

Histiocytosis, Non-Langerhans-Cell

Skin Diseases

Lipogranulomatosis

Non-Langerhans-Cell Histiocytosis

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Olaparib

Piperazine

Mebendazole

Piperazine citrate

DMP 777

Sirolimus

Palbociclib

Poly(ADP-ribose) Polymerase Inhibitors

Temsirolimus

MTOR Inhibitors

Vemurafenib

Tipifarnib

Ensartinib

Enzyme Inhibitors

Protein Kinase Inhibitors

Patients receive tipifarnib PO or via nasogastric or gastric tube BID on days 1-7 and 15-21. Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity.

Patients with a NTRK1, NTRK2, or NTRK3 gene fusion receive larotrectinib sulfate PO or via nasogastric- or gastric-tube BID on days 1-28. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.

Patients with a FGFR1, FGFR2, FGFR3, or FGFR4 gene mutation receive erdafitinib PO QD on days 1-28 of each cycle. Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Patients undergo an x-ray, CT scan, MRI, radionuclide imaging, and/or bone scan, as well as a bone marrow aspiration and/or biopsy during screening and on study. Patients also undergo blood sample collection on study.

Patients with an EZH2, SMARCB1, or SMARCA4 gene mutation receive tazemetostat PO BID on days 1-28. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.

Patients with a TSC1, TSC2, or PI3K/mTOR gene mutations receive PI3K/mTOR inhibitor LY3023414 PO BID on days 1-28. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.

Patients with an activating MAPK pathway gene mutation receive selumetinib sulfate PO BID on days 1-28. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.

Patients with an ALK or ROS1 gene alteration receive ensartinib PO BID on days 1-28. Cycles repeat every 28 days for 2 years (up to 26 cycles) in the absence of disease progression or unacceptable toxicity. Patients undergo an x-ray, CT scan, MRI, PET scan, radionuclide imaging, and/or bone scan, as well as a bone marrow aspiration and/or biopsy during screening and on study. Patients also undergo blood sample collection on study.

Patients with a BRAF V600 gene mutation receive vemurafenib PO BID on days 1-28. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.

Patients deleterious ATM, BRCA1, BRCA2, RAD51C, or RAD51D gene mutations receive olaparib PO BID on days 1-28. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.

Patients with Rb positive advanced solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with activating alterations in cell cycle genes receive palbociclib PO QD on days 1-21. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Patients with MAPK pathway mutations receive ulixertinib PO BID. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Patients with activating RET gene alterations receive selpercatinib PO BID on days 1-28. Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Patients may also undergo PET, CT, MRI, PET/CT, PET/MRI, and/or CT/MRI, scintigraphy, and x-ray imaging throughout the trial.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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)	NCT03213678	Advanced Malign... Ann Arbor Stage... Ann Arbor Stage... Malignant Gliom... Recurrent Epend... Recurrent Ewing... Recurrent Gliom... Recurrent Hepat... Recurrent Lange... Recurrent Malig... Recurrent Malig... Recurrent Medul... Recurrent Neuro... Recurrent Non-H... Recurrent Osteo... Recurrent Perip... Recurrent Prima... Recurrent Rhabd... Recurrent Soft ... Refractory Lang... Refractory Mali... Refractory Mali... Refractory Neur... Refractory Non-... Refractory Prim... Rhabdoid Tumor Stage III Osteo... Stage III Soft ... Stage IV Osteos... Stage IV Soft T... Stage IVA Osteo... Stage IVB Osteo... Wilms Tumor	Biospecimen Col... Computed Tomogr... FDG-Positron Em... Magnetic Resona... Samotolisib X-Ray Imaging	12 Months - 21 Years	National Cancer Institute (NCI)
Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial)	NCT03155620	Advanced Malign... Ann Arbor Stage... Ann Arbor Stage... Histiocytic Sar... Juvenile Xantho... Langerhans Cell... Malignant Gliom... Recurrent Child... Recurrent Epend... Recurrent Ewing... Recurrent Gliom... Recurrent Hepat... Recurrent Lange... Recurrent Malig... Recurrent Malig... Recurrent Medul... Recurrent Neuro... Recurrent Non-H... Recurrent Osteo... Recurrent Perip... Recurrent Prima... Recurrent Rhabd... Recurrent Soft ... Refractory Ewin... Refractory Glio... Refractory Hepa... Refractory Lang... Refractory Mali... Refractory Mali... Refractory Medu... Refractory Neur... Refractory Non-... Refractory Oste... Refractory Peri... Refractory Prim... Refractory Rhab... Refractory Rhab... Rhabdoid Tumor Stage III Osteo... Stage III Soft ... Stage IV Osteos... Stage IV Soft T... Stage IVA Osteo... Stage IVB Osteo... Wilms Tumor	Biopsy Biospecimen Col... Bone Marrow Asp... Bone Scan Computed Tomogr... Ensartinib Erdafitinib Laboratory Biom... Larotrectinib S... Magnetic Resona... Mutation Carrie... Olaparib Palbociclib Pharmacological... Positron Emissi... Radionuclide Im... Samotolisib Selpercatinib Selumetinib Sul... Tazemetostat Tipifarnib Ulixertinib Vemurafenib X-Ray Imaging	12 Months - 21 Years	National Cancer Institute (NCI)

Spots Global Cancer Trial Database for samotolisib

Every month we try and update this database with for samotolisib cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for samotolisib

Every month we try and update this database with for samotolisib cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for samotolisib cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.