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)

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Recruiting
CT.gov ID
NCT03213678
Collaborator
(none)
24
125
1
86
0.2
0

Study Details

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:
  1. 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:
  1. 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.

  2. To obtain information about the tolerability of LY3023414 in children with relapsed or refractory cancer.

  3. To characterize the pharmacokinetics of LY3023414 in children with recurrent or refractory cancer.

EXPLORATORY OBJECTIVES:
  1. 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.

  2. To explore approaches to profiling changes in tumor genomics over time through evaluation of circulating tumor deoxyribonucleic acid (DNA).

  3. 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.

After completion of study treatment, patients are followed up periodically.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
NCI-COG Pediatric MATCH (Molecular Analysis For Therapy Choice)- Phase 2 Subprotocol of LY3023414 in Patients With Solid Tumors
Actual Study Start Date :
Jul 31, 2017
Anticipated Primary Completion Date :
Sep 30, 2024
Anticipated Study Completion Date :
Sep 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment (samotolisib)

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.

Other: Laboratory Biomarker Analysis
Correlative studies

Other: Pharmacological Study
Correlative studies

Drug: Samotolisib
Given PO
Other Names:
  • 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-
  • LY 3023414
  • LY-3023414
  • LY3023414
  • WHO 10889
  • Outcome Measures

    Primary Outcome Measures

    1. Response rate [Up to 2 years]

      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.

    Secondary Outcome Measures

    1. Percentage of patients experiencing grade 3 or 4 adverse events [From enrollment to the end of treatment, up to 2 years]

      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.

    2. Progression free survival (PFS) [From the initiation of protocol treatment to the occurrence of any of the following events: disease progression or disease recurrence or death from any cause, assessed up to 2 years]

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

    3. Pharmacokinetic (PK) parameters [At baseline, 30 minutes, 1, 2, 4, 4, 6-8 hours, and 24 hours after the morning dose on day 1 course 1, pre-dose and at 1-2 hours after the morning dose on day 15 course 1]

      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).

    Other Outcome Measures

    1. Potential predictive biomarker identification using additional genomic, transcriptomic, and proteomic testing platforms [Up to 3 years]

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

    2. Biallelic loss of function frequency and mechanism [Up to 3 years]

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

    3. Change in tumor genomic profile [Baseline up to 3 years]

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

    4. TSC1, TSC2, and PTEN expression levels [Up to 3 years]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Months to 21 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 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 m2 at the time of study enrollment; patients accruing to dose level 2 must have a body surface area >= 0.37 m2 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Children's Hospital of Alabama Birmingham Alabama United States 35233
    2 Providence Alaska Medical Center Anchorage Alaska United States 99508
    3 Banner Children's at Desert Mesa Arizona United States 85202
    4 Banner University Medical Center - Tucson Tucson Arizona United States 85719
    5 Arkansas Children's Hospital Little Rock Arkansas United States 72202-3591
    6 Kaiser Permanente Downey Medical Center Downey California United States 90242
    7 City of Hope Comprehensive Cancer Center Duarte California United States 91010
    8 Loma Linda University Medical Center Loma Linda California United States 92354
    9 Miller Children's and Women's Hospital Long Beach Long Beach California United States 90806
    10 Children's Hospital Los Angeles Los Angeles California United States 90027
    11 Mattel Children's Hospital UCLA Los Angeles California United States 90095
    12 Valley Children's Hospital Madera California United States 93636
    13 UCSF Benioff Children's Hospital Oakland Oakland California United States 94609
    14 Kaiser Permanente-Oakland Oakland California United States 94611
    15 University of California Davis Comprehensive Cancer Center Sacramento California United States 95817
    16 UCSF Medical Center-Mission Bay San Francisco California United States 94158
    17 Children's Hospital Colorado Aurora Colorado United States 80045
    18 Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver Colorado United States 80218
    19 Yale University New Haven Connecticut United States 06520
    20 Alfred I duPont Hospital for Children Wilmington Delaware United States 19803
    21 MedStar Georgetown University Hospital Washington District of Columbia United States 20007
    22 Children's National Medical Center Washington District of Columbia United States 20010
    23 University of Florida Health Science Center - Gainesville Gainesville Florida United States 32610
    24 Nemours Children's Clinic-Jacksonville Jacksonville Florida United States 32207
    25 University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida United States 33136
    26 Nicklaus Children's Hospital Miami Florida United States 33155
    27 AdventHealth Orlando Orlando Florida United States 32803
    28 Arnold Palmer Hospital for Children Orlando Florida United States 32806
    29 Nemours Children's Hospital Orlando Florida United States 32827
    30 Nemours Children's Clinic - Pensacola Pensacola Florida United States 32504
    31 Johns Hopkins All Children's Hospital Saint Petersburg Florida United States 33701
    32 Saint Joseph's Hospital/Children's Hospital-Tampa Tampa Florida United States 33607
    33 Children's Healthcare of Atlanta - Egleston Atlanta Georgia United States 30322
    34 Memorial Health University Medical Center Savannah Georgia United States 31404
    35 Saint Luke's Cancer Institute - Boise Boise Idaho United States 83712
    36 University of Chicago Comprehensive Cancer Center Chicago Illinois United States 60637
    37 Saint Jude Midwest Affiliate Peoria Illinois United States 61637
    38 Southern Illinois University School of Medicine Springfield Illinois United States 62702
    39 Riley Hospital for Children Indianapolis Indiana United States 46202
    40 Blank Children's Hospital Des Moines Iowa United States 50309
    41 University of Iowa/Holden Comprehensive Cancer Center Iowa City Iowa United States 52242
    42 Norton Children's Hospital Louisville Kentucky United States 40202
    43 Children's Hospital New Orleans New Orleans Louisiana United States 70118
    44 Ochsner Medical Center Jefferson New Orleans Louisiana United States 70121
    45 Eastern Maine Medical Center Bangor Maine United States 04401
    46 Sinai Hospital of Baltimore Baltimore Maryland United States 21215
    47 Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore Maryland United States 21287
    48 Massachusetts General Hospital Cancer Center Boston Massachusetts United States 02114
    49 Dana-Farber Cancer Institute Boston Massachusetts United States 02215
    50 C S Mott Children's Hospital Ann Arbor Michigan United States 48109
    51 Michigan State University Clinical Center East Lansing Michigan United States 48824-7016
    52 Helen DeVos Children's Hospital at Spectrum Health Grand Rapids Michigan United States 49503
    53 Bronson Methodist Hospital Kalamazoo Michigan United States 49007
    54 Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis Minnesota United States 55404
    55 University of Minnesota/Masonic Cancer Center Minneapolis Minnesota United States 55455
    56 Mayo Clinic in Rochester Rochester Minnesota United States 55905
    57 University of Mississippi Medical Center Jackson Mississippi United States 39216
    58 Children's Mercy Hospitals and Clinics Kansas City Missouri United States 64108
    59 Cardinal Glennon Children's Medical Center Saint Louis Missouri United States 63104
    60 Washington University School of Medicine Saint Louis Missouri United States 63110
    61 Mercy Hospital Saint Louis Saint Louis Missouri United States 63141
    62 Children's Hospital and Medical Center of Omaha Omaha Nebraska United States 68114
    63 University of Nebraska Medical Center Omaha Nebraska United States 68198
    64 University Medical Center of Southern Nevada Las Vegas Nevada United States 89102
    65 Sunrise Hospital and Medical Center Las Vegas Nevada United States 89109
    66 Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas Nevada United States 89135
    67 Summerlin Hospital Medical Center Las Vegas Nevada United States 89144
    68 Hackensack University Medical Center Hackensack New Jersey United States 07601
    69 Morristown Medical Center Morristown New Jersey United States 07960
    70 Saint Peter's University Hospital New Brunswick New Jersey United States 08901
    71 Albany Medical Center Albany New York United States 12208
    72 Montefiore Medical Center - Moses Campus Bronx New York United States 10467
    73 Roswell Park Cancer Institute Buffalo New York United States 14263
    74 The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park New York United States 11040
    75 NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York New York United States 10032
    76 Memorial Sloan Kettering Cancer Center New York New York United States 10065
    77 NYP/Weill Cornell Medical Center New York New York United States 10065
    78 University of Rochester Rochester New York United States 14642
    79 State University of New York Upstate Medical University Syracuse New York United States 13210
    80 New York Medical College Valhalla New York United States 10595
    81 Mission Hospital Asheville North Carolina United States 28801
    82 Carolinas Medical Center/Levine Cancer Institute Charlotte North Carolina United States 28203
    83 Duke University Medical Center Durham North Carolina United States 27710
    84 Sanford Broadway Medical Center Fargo North Dakota United States 58122
    85 Cincinnati Children's Hospital Medical Center Cincinnati Ohio United States 45229
    86 Rainbow Babies and Childrens Hospital Cleveland Ohio United States 44106
    87 Cleveland Clinic Foundation Cleveland Ohio United States 44195
    88 Nationwide Children's Hospital Columbus Ohio United States 43205
    89 Dayton Children's Hospital Dayton Ohio United States 45404
    90 ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo Ohio United States 43606
    91 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
    92 Legacy Emanuel Children's Hospital Portland Oregon United States 97227
    93 Oregon Health and Science University Portland Oregon United States 97239
    94 Geisinger Medical Center Danville Pennsylvania United States 17822
    95 Children's Hospital of Philadelphia Philadelphia Pennsylvania United States 19104
    96 Children's Hospital of Pittsburgh of UPMC Pittsburgh Pennsylvania United States 15224
    97 Prisma Health Richland Hospital Columbia South Carolina United States 29203
    98 BI-LO Charities Children's Cancer Center Greenville South Carolina United States 29605
    99 Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota United States 57117-5134
    100 East Tennessee Childrens Hospital Knoxville Tennessee United States 37916
    101 Saint Jude Children's Research Hospital Memphis Tennessee United States 38105
    102 Vanderbilt University/Ingram Cancer Center Nashville Tennessee United States 37232
    103 Dell Children's Medical Center of Central Texas Austin Texas United States 78723
    104 Medical City Dallas Hospital Dallas Texas United States 75230
    105 UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas United States 75390
    106 Cook Children's Medical Center Fort Worth Texas United States 76104
    107 Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston Texas United States 77030
    108 M D Anderson Cancer Center Houston Texas United States 77030
    109 Children's Hospital of San Antonio San Antonio Texas United States 78207
    110 Methodist Children's Hospital of South Texas San Antonio Texas United States 78229
    111 University of Texas Health Science Center at San Antonio San Antonio Texas United States 78229
    112 Scott and White Memorial Hospital Temple Texas United States 76508
    113 Primary Children's Hospital Salt Lake City Utah United States 84113
    114 University of Vermont and State Agricultural College Burlington Vermont United States 05405
    115 Children's Hospital of The King's Daughters Norfolk Virginia United States 23507
    116 Virginia Commonwealth University/Massey Cancer Center Richmond Virginia United States 23298
    117 Seattle Children's Hospital Seattle Washington United States 98105
    118 Providence Sacred Heart Medical Center and Children's Hospital Spokane Washington United States 99204
    119 Mary Bridge Children's Hospital and Health Center Tacoma Washington United States 98405
    120 Madigan Army Medical Center Tacoma Washington United States 98431
    121 West Virginia University Healthcare Morgantown West Virginia United States 26506
    122 University of Wisconsin Carbone Cancer Center Madison Wisconsin United States 53792
    123 Children's Hospital of Wisconsin Milwaukee Wisconsin United States 53226
    124 San Jorge Children's Hospital San Juan Puerto Rico 00912
    125 University Pediatric Hospital San Juan Puerto Rico 00926

    Sponsors and Collaborators

    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Theodore W Laetsch, Children's Oncology Group

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT03213678
    Other Study ID Numbers:
    • NCI-2017-01249
    • NCI-2017-01249
    • APEC1621D
    • APEC1621D
    • APEC1621D
    • U10CA180886
    First Posted:
    Jul 11, 2017
    Last Update Posted:
    Aug 25, 2022
    Last Verified:
    May 1, 2022

    Study Results

    No Results Posted as of Aug 25, 2022