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NCT03213678 · REGISTRY CONDITION SEARCH

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)

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2026-04-21

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Objective Response Rate

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outcome · POSTED

Percentage of Patients Experiencing Grade 3 or 4 Adverse Events

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outcome · POSTED

Progression Free Survival (PFS)

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outcome · POSTED

Pharmacokinetic (PK) of Samotolisib, Area Under the Curve (AUC).

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outcome · NOT POSTED

Potential Predictive Biomarker Identification Using Additional Genomic, Transcriptomic, and Proteomic Testing Platforms

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outcome · NOT POSTED

Biallelic Loss of Function Frequency and Mechanism

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outcome · NOT POSTED

Change in Tumor Genomic Profile

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outcome · NOT POSTED

TSC1, TSC2, and PTEN Expression Levels

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * Patient must have enrolled onto APEC1621SC/NCI-2017-01251/ NCT03155620 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 as defined in APEC1621SC; note that treatment assignment may be to primary cohort A for patients with TSC1 or TSC2 loss of function mutations or primary cohort B for patients with other PI3K/MTOR pathway mutations * 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 any lesion that is at minimum 10 mm in one dimension on standard magnetic resonance imaging (MRI) or computed tomography (CT) * 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 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
healthy Volunteers
false
maximum Age
21 Years
minimum Age
12 Months
sex
ALL
std Ages
  1. CHILD
  2. ADULT
Treatment arms and interventions
arm Groups
  1. description
    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.
    intervention Names
    1. Procedure: Biospecimen Collection
    2. Procedure: Computed Tomography
    3. Procedure: FDG-Positron Emission Tomography
    4. Procedure: Magnetic Resonance Imaging
    5. Drug: Samotolisib
    6. Procedure: X-Ray Imaging
    label
    Treatment (samotolisib)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Treatment (samotolisib)
    description
    Undergo blood specimen collection
    name
    Biospecimen Collection
    other Names
    1. Biological Sample Collection
    2. Biospecimen Collected
    3. Specimen Collection
    type
    PROCEDURE
  2. arm Group Labels
    1. Treatment (samotolisib)
    description
    Undergo CT
    name
    Computed Tomography
    other Names
    1. CAT
    2. CAT Scan
    3. Computed Axial Tomography
    4. Computerized Axial Tomography
    5. Computerized axial tomography (procedure)
    6. Computerized Tomography
    7. Computerized Tomography (CT) scan
    8. CT
    9. CT Scan
    10. tomography
    type
    PROCEDURE
  3. arm Group Labels
    1. Treatment (samotolisib)
    description
    Undergo FDG-PET
    name
    FDG-Positron Emission Tomography
    other Names
    1. FDG
    2. FDG-PET
    3. FDG-PET Imaging
    type
    PROCEDURE
  4. arm Group Labels
    1. Treatment (samotolisib)
    description
    Undergo MRI
    name
    Magnetic Resonance Imaging
    other Names
    1. Magnetic Resonance
    2. Magnetic Resonance Imaging (MRI)
    3. Magnetic resonance imaging (procedure)
    4. Magnetic Resonance Imaging Scan
    5. Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
    6. MR
    7. MR Imaging
    8. MRI
    9. MRI Scan
    10. MRIs
    11. NMR Imaging
    12. NMRI
    type
    PROCEDURE
  5. arm Group Labels
    1. Treatment (samotolisib)
    description
    Given PO
    name
    Samotolisib
    other Names
    1. 2H-Imidazo(4,5-C)quinolin-2-one, 1,3-Dihydro-8-(5-(1-hydroxy-1-methylethyl)-3-pyridinyl)-1-((2S)-2-methoxypropyl)-3-methyl-
    2. LY 3023414
    3. LY-3023414
    4. LY3023414
    5. WHO 10889
    type
    DRUG
  6. arm Group Labels
    1. Treatment (samotolisib)
    description
    Undergo x-ray
    name
    X-Ray Imaging
    other Names
    1. Conventional X-Ray
    2. Diagnostic Radiology
    3. Medical Imaging, X-Ray
    4. Plain film radiographs
    5. Radiographic Imaging
    6. Radiographic imaging procedure (procedure)
    7. Radiography
    8. RG
    9. Static X-Ray
    10. X-Ray
    type
    PROCEDURE
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
18
type
ACTUAL
Registered outcome plans (not posted results)
other Outcomes
  1. description
    A descriptive analysis will be performed and will be summarized with simple summary statistics. All of these analyses will be descriptive in nature.
    measure
    Potential Predictive Biomarker Identification Using Additional Genomic, Transcriptomic, and Proteomic Testing Platforms
    time Frame
    Up to 3 years
  2. description
    A descriptive analysis will be performed and will be summarized with simple summary statistics. All of these analyses will be descriptive in nature.
    measure
    Biallelic Loss of Function Frequency and Mechanism
    time Frame
    Up to 3 years
  3. description
    A descriptive analysis will be performed and will be summarized with simple summary statistics. All of these analyses will be descriptive in nature.
    measure
    Change in Tumor Genomic Profile
    time Frame
    Baseline up to 3 years
  4. description
    A descriptive analysis will be performed and will be summarized with simple summary statistics. All of these analyses will be descriptive in nature.
    measure
    TSC1, TSC2, and PTEN Expression Levels
    time Frame
    Up to 3 years
primary Outcomes
  1. description
    A responder is defined as a patient who achieves a best response of partial response or complete response on the study. Response rates will be calculated as the percent of evaluable patients who are responders. The revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) was used to determine response and progression in this study, with specific criteria outlined for the different subtypes of tumors (e.g., 2-dimensional measurements for central nervous system (CNS) tumors).
    measure
    Objective Response Rate
    time Frame
    Up to 2 years from study entry
secondary Outcomes
  1. description
    Percentage of patients experiencing grade 3 or higher adverse events will be evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0
    measure
    Percentage of Patients Experiencing Grade 3 or 4 Adverse Events
    time Frame
    Up to 2 years from study entry
  2. description
    The Kaplan-Meier method will be used to estimate the 3-month PFS. PFS is defined as time from initiation of protocol treatment to disease progression, recurrence, death from any cause, or date of last contact.
    measure
    Progression Free Survival (PFS)
    time Frame
    Up to 3 months from study entry
  3. description
    The mean (sd) of the AUC
    measure
    Pharmacokinetic (PK) of Samotolisib, Area Under the Curve (AUC).
    time Frame
    Up to day 15 of cycle 1
Full study description
brief 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.
Source references
references
  1. citation
    Hattinger CM, Patrizio MP, Magagnoli F, Luppi S, Serra M. An update on emerging drugs in osteosarcoma: towards tailored therapies? Expert Opin Emerg Drugs. 2019 Sep;24(3):153-171. doi: 10.1080/14728214.2019.1654455. Epub 2019 Aug 14.
    pmid
    31401903
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice