Combination Therapy for the Treatment of Diffuse Midline Gliomas

May 11, 2023 updated by: Sabine Mueller, MD, PhD, University of California, San Francisco

A Combination Therapy Trial Using an Adaptive Platform Design for Children and Young Adults With Diffuse Midline Gliomas (DMGs) Including Diffuse Intrinsic Pontine Gliomas (DIPGs) at Initial Diagnosis, Post-Radiation Therapy and at Time of Progression

This phase II trial determines if the combination of ONC201 with different drugs, panobinostat or paxalisib, is effective for treating patients with diffuse midline gliomas (DMGs). Despite years of research, little to no progress has been made to improve outcomes for patients with DMGs, and there are few treatment options. ONC201, panobinostat, and paxalisib are all enzyme inhibitors that may stop the growth of tumor cells by clocking some of the enzymes needed for cell growth. This phase II trial assesses different combinations of these drugs for the treatment of DMGs.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

OUTLINE:

Participants will be randomized at study entry to one of the three study arms and subsequently will be included in one to three phases, and one of 3 cohorts depending on their stage of disease and prior treatment.

PRIMARY OBJECTIVES:

I. To assess efficacy of combination therapy with ONC201 (ONC201) and novel agent in participants with DMG based on median progression-free survival at 6 months (PFS6) (Cohorts 1 and 2).

II. To assess efficacy of combination therapy with ONC201 and novel agent in participants with recurrent DMG based on overall survival at 7 months (OS7) (Cohort 3).

EXPLORATORY OBJECTIVES:

I. To confirm blood brain barrier (BBB) penetration of ONC201 in DMGs by measuring the concentration of ONC201 in tumor tissue (All cohorts; target validation phase).

II. To confirm BBB penetration of novel agents in DMGs by measuring the concentration of drug (or metabolite) in tumor tissue (All cohorts; target validation phase).

III. To assess changes in immune cell infiltration in DMG tumor tissue after 1 or 2 doses of ONC201 (All cohorts; target validation phase).

IV. To assess correlation of intratumoral concentration of ONC201 with clinical outcome (All cohorts; target validation phase).

V. To assess correlation of intratumoral drug concentration of novel agents with clinical outcome. (All cohorts; target validation phase).

VI. To assess if intratumoral ONC201 concentrations differ in irradiated versus nonirradiated tumor tissue. (All cohorts; target validation phase).

VII. To assess if intratumoral concentrations of novel agents differ in irradiated versus nonirradiated tumor tissue. (All cohorts; target validation phase).

VIII. To assess tumor tissue biomarkers in the context of clinical outcome, such as PFS6 and/or OS12. (All cohorts; target validation phase).

IX. To assess efficacy of combination therapy ONC201 and novel agent based on overall survival at 12 months (OS12). (All cohorts; maintenance combinations).

X. To assess toxicity of combination therapy ONC201 and novel agents. (All cohorts; maintenance combinations).

XI. To assess the toxicity of weekly ONC201 in combination with up-front radiation therapy. (Cohort 1; radiation therapy phase).

XII. To assess the toxicity of twice weekly ONC201 in combination with up-front radiation therapy. (Cohort 1; radiation therapy phase).

XIII. To assess the toxicity of novel agents in combination with up-front radiation therapy. (Cohort 1; radiation therapy phase).

XIV. To assess the toxicity of weekly ONC201 in combination with re-irradiation after progression. (Cohort 3).

XV. To assess the toxicity of twice weekly ONC201 in combination with re-irradiation therapy after progression. (Cohort 3).

XVI. To assess the toxicity of novel agents in combination with re-irradiation after progression. (Cohort 3).

XVII. To assess the toxicity of ONC201 in combination with novel agents in participants after re-irradiation after progression. (Cohort 3).

XVIII. To assess cerebrospinal fluid (CSF) biomarkers in the context of clinical outcome, such as PFS6 and/or OS12. (All cohorts/phases).

XIX. To assess levels of circulating tumor deoxyribonucleic acid (ctDNA) in the context of imaging response criteria and clinical outcome, such as PFS6 and/or OS12. (All cohorts/phases).

XX. To assess single cell ribonucleic acid (RNA) sequencing in the context of clinical outcome, such as PFS6 and/or OS12. (All cohorts/phases).

XXI. To assess microbiome and flow cytometry studies in the context of imaging and clinical outcomes using descriptive statistics.

XXII. To assess Health-Related Quality of Life (HRQOL) and cognitive measures. (All cohorts/phases).

XXIII. To assess patient and/or proxy satisfaction with study participation via patient-reported outcome (PRO) measures. (All cohorts/phases).

COHORT DESCRIPTIONS:

COHORTS 1A & 2A ( Target Validation cohorts); Includes newly diagnosed participants that have not yet undergone tumor tissue collection. Cohort 1A will include participants with DMG who have not yet completed radiation therapy and Cohort 2A will include participants with DMG who have completed radiation therapy.

COHORTS 1B & 2B: Includes newly-diagnosed participants who have already undergone tumor tissue collection. Cohort 1B will include participants with DMG who have not yet completed radiation therapy and Cohort 2B will include participants with DMG who have completed radiation therapy.

COHORTS 3A & 3B: Includes participants with progressive DMG. Cohort 3A will include participants planned for standard of care (SOC) tumor tissue collection. Cohort 3B will include participants not planned for SOC tumor tissue collection. The nomenclature will delineate participants previously enrolled in Cohorts 1 or 2.

TREATMENT ARM DESCRIPTIONS:

ARM 2: During the trial validation phase, patients without prior biopsy receive ONC201 PO on day -1 prior to standard of care biopsy. During the radiation/re-irradiation phase, patients without prior radiation therapy or have disease progression after radiation therapy undergo weekly radiation therapy and receive ONC201 PO weekly during radiation therapy. During the maintenance phase, patients receive ONC201 PO weekly and paxalisib PO daily (QD). Cycles repeat every 28 days (4 weeks) in the absence of adverse events of unacceptable toxicity.

ARM 4: During the trial validation phase, patients without prior biopsy receive ONC201 PO on days -2 and -1 prior to standard of care biopsy. During the radiation/re-irradiation phase, patients may receive ONC201 PO weekly during radiation therapy. During the maintenance phase, patients receive ONC201 PO weekly and paxalisib PO QD. Cycles repeat every 28 days (4 weeks) in the absence of adverse events or unacceptable toxicity.

ARM 6: During trial validation phase, patients without prior biopsy receive paxalisib PO on day -1 prior to standard of care biopsy. During the radiation/re-irradiation phase, patients without prior radiation therapy or have disease progression after radiation therapy undergo weekly radiation therapy and receive paxalisib PO daily during radiation therapy. During the maintenance phase, patients receive ONC201 PO weekly and paxalisib PO QD. Cycles repeat every 28 days (4 weeks) in the absence of adverse events of unacceptable toxicity.

After completion of study treatment, patient are followed every 12 months.

Study Type

Interventional

Enrollment (Anticipated)

324

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
      • Adelaide, Australia
        • Recruiting
        • Women and Children's Hospital
        • Contact:
          • Jordan Hansford
      • Sydney, Australia, 2031
    • New South Wales
      • New Lambton Heights, New South Wales, Australia, 2305
      • Westmead, New South Wales, Australia, 2152
        • Recruiting
        • The Children's Hospital at Westmead
        • Contact:
        • Principal Investigator:
          • Dinisha Govender
    • Queensland
      • South Brisbane, Queensland, Australia
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Recruiting
        • Monash Children's Hospital
        • Contact:
      • Melbourne, Victoria, Australia, 3052
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
  • Israel
      • Jerusalem, Israel, 9103102
        • Recruiting
        • Shaare Zedek Medical Center
        • Contact:
    • Ramat Gan
      • Tel Hashomer, Ramat Gan, Israel
        • Recruiting
        • Sheba Medical Center
        • Contact:
          • Michal Yalon
  • Netherlands
      • Utrecht, Netherlands
        • Recruiting
        • Princess Maxima Center
        • Contact:
          • Jasper van der Lugt, MD, PhD
          • Phone Number: + 31 (0) 88 972 63 00
        • Contact:
          • Raoull Hoogendijk
  • New Zealand
      • Auckland, New Zealand
        • Recruiting
        • Starship Children's Hospital
        • Contact:
          • Karen Tsui Tsui, MBChB, Dip Paed, FRACP
          • Phone Number: +64 9 367 0000
          • Email: karent@adhb.govt.nz
  • Switzerland
      • Zürich, Switzerland
        • Recruiting
        • The University Children's Hospital in Zurich
        • Contact:
        • Contact:
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • University of Alabama at Birmingham
        • Contact:
        • Principal Investigator:
          • Girish Dhall, MD
    • California
      • Los Angeles, California, United States, 90027
        • Recruiting
        • Children's Hospital Los Angeles
        • Contact:
      • San Diego, California, United States, 92123
        • Recruiting
        • University of California, San Diego / Rady Children's Hospital, San Diego
        • Contact:
      • San Francisco, California, United States, 94143
        • Recruiting
        • University of California, San Francisco
        • Contact:
        • Contact:
          • PNOC022@ucsf.edu
        • Principal Investigator:
          • Sabine Mueller, MD, PhD
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins University
        • Contact:
        • Principal Investigator:
          • Kenneth Cohen, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02215-6024
        • Recruiting
        • Dana-Farber Cancer Institute Harvard University
        • Contact:
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan
        • Contact:
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University in St. Louis
        • Contact:
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • Hackensack Meridian Health
        • Contact:
        • Principal Investigator:
          • Derek Hanson, MD
    • New York
    • North Carolina
      • Durham, North Carolina, United States, 27708
        • Recruiting
        • Duke Univeristy
        • Contact:
        • Contact:
        • Principal Investigator:
          • David Ashley, MBBS (Hon), FRACP, PHD
    • Oregon
      • Portland, Oregon, United States, 97239
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Children's Hospital of Philadelphia
        • Contact:
        • Principal Investigator:
          • Cassie Kline, MD
    • Utah
      • Salt Lake City, Utah, United States, 84101
    • Washington
      • Seattle, Washington, United States, 98101

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 39 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • COHORT 1A AND 1B: New diagnosis of DMG with imaging and/or pathology consistent with a DMG, including spinal cord tumors. In cohort 1B, previous tumor tissue confirmation of DMG is mandatory and pathology must be consistent with a DMG including diffuse midline glioma H3K27M mutant; World Health Organization (WHO) grade III and IV H3 wildtype gliomas.
  • COHORT 2A AND 2B: Diagnosis of DMG with imaging and/or pathology consistent with a DMG, including spinal cord tumors, who have complete standard-of-care radiation therapy. In cohort 2B, previous tumor tissue confirmation of DMG is mandatory and pathology must be consistent with a DMG including diffuse midline glioma H3K27M mutant; WHO grade III and IV H3 wildtype gliomas.
  • COHORT 2A AND 2B: Participants must be within 4-14 weeks of completion of radiation.
  • COHORT 3A AND 3B: Diagnosis of recurrent DMG with imaging and/or pathology consistent with a DMG, including spinal cord tumors, who have complete standard-of-care radiation therapy. In cohort 3B, previous tumor tissue confirmation of DMG is mandatory and pathology must be consistent with a DMG including diffuse midline glioma H3K27M mutant; WHO grade III and IV H3 wildtype gliomas.
  • COHORT 3A AND 3B: Participants must have evidence of progression and not have received any treatment for this progression and have not previously received re-irradiation.
  • Age 2 to 39 years
  • Participants must have recovered from all acute side effects of prior therapy
  • Participant body weight must be above the minimum necessary for the participant to receive ONC201 (at least 10 kg)

  • From the projected start of scheduled study treatment, the following time periods must have elapsed: At least 7 days after last dose of a biologic agent or beyond time during which adverse events are known to occur for a biologic agent, 5 half-lives from any investigational agent, 4 weeks from cytotoxic therapy (except 23 days for temozolomide and 6 weeks from nitrosoureas), 6 weeks from antibodies, or 4 weeks (or 5 half-lives, whichever is shorter) from other anti-tumor therapies.

    • For participants who have received radiotherapy, participants in Cohort 2 must be between 4 and 14 weeks from the completion of local up-front radiotherapy and not have received additional therapy beyond completion of radiation therapy.
    • The use of bevacizumab to control radiation therapy-induced edema is allowed (if used for tumor-directed therapy, please see required time period above). Dosing limitations are as follows: Bevacizumab (or equivalent) for up to a maximum of 5 doses, dosing per institutional standard. There is no required washout period.
    • Prior use of temozolomide during radiation at maximum of the standard pediatric dosing (defined as 90 mg/m2 /dose continuously during radiation therapy for 42 days) or dexamethasone is allowed.
  • Corticosteroids: Participants who are receiving dexamethasone must be on a stable or decreasing dose for at least 3 days prior to baseline magnetic resonance imaging (MRI) scan.
  • Peripheral absolute neutrophil count (ANC) >= 1000/mm^3 (1.0g/l) AND
  • Platelet count >= 100,000/mm^3 (100x10^9/l) (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment).
  • Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 OR
  • A serum creatinine within the normal limits for age
  • Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age AND
  • Serum glutamate pyruvate transaminase (SGPT)(alanine aminotransferase (ALT)) =< 2 x ULN AND
  • Serum albumin >= 2 g/dL
  • No evidence of dyspnea at rest, no exercise intolerance due to pulmonary insufficiency, and a pulse oximetry of > 92% while breathing room air.
  • Diarrhea < grade 2 by Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0
  • Non-fasting glucose < 125 mg/dL without the use of antihyperglycemic agents
  • If non-fasting glucose > 125 mg/dL, a fasting glucose should be done. If fasting glucose =< 160 mg/dL without the use of antihyperglycemic agents, participants will meet adequate metabolic function criteria
  • Triglycerides of < 300 mg/dl and total cholesterol of < 300 mg/dl - can be on lipid lowering medications as needed to achieve.
  • No history of congestive heart failure or family history of long QT syndrome.
  • ECG must be obtained to verify the QTC. If an abnormal reading is obtained, the ECG should be repeated in triplicate. QTC < 470 msec.
  • Participants with history of congestive heart failure, at risk of having or have underlying cardiovascular disease, or with history of exposure to cardiotoxic drugs must have adequate cardiac function as determined by echocardiogram. Shortening fraction of >= 27%.
  • Participants with seizure disorder may be enrolled if seizure disorder is well controlled
  • The effects of the study drugs on the developing human fetus are unknown. For this reason, females of child-bearing potential and males must agree to use adequate contraception. Adequate methods include: hormonal or barrier method of birth control; or abstinence prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Males treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and for the duration of study participation.
  • Karnofsky >= 50 for participants > 16 years of age and Lansky >= 50 for participants =< 16 years of age. Participants 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.
  • Participants must be willing to provide adequate tissue. A minimum of 10-20 paraffin embedded unstained slides OR 1 block with tumor content of 40% or greater is required. Participants who do not meet this criteria must be discussed with Study Chair(s).
  • A legal parent/guardian or participant must be able to understand, and willing to sign, a written informed consent and assent document, as appropriate.

Exclusion Criteria:

  • COHORT 1A AND 1B:

    • Prior exposure to radiation therapy.
    • Thalamic H3K27M DMG.

  • COHORT 2A AND 2B:

    o For tumors that do not have a pontine or spinal cord epicenter the following specific exclusion criteria apply: o Thalamic H3K27M DMG that has undergone standard radiation without concurrent therapy (other than temozolomide).

  • COHORT 1A AND 2A:

    o Deemed not appropriate for tissue resection/biopsy.

  • COHORT 3A AND 3B:

    • Prior exposure to re-irradiation for tumor progression.
    • Patients who participated in trials investigating ONC201 in the upfront setting will not be eligible. Prior ONC201 exposure as part of PNOC022 or expanded access programs will be allowed.
  • Diagnosis of a histone H3 wildtype grade II diffuse astrocytoma
  • Participants who are currently receiving another investigational drug. Investigational imaging agents or agents used to enhance tumor visibility on imaging or during tumor biopsy/resection should be discussed with the study chairs.
  • Participants who are currently receiving other anti-cancer agents
  • Participants with a known disorder that affects their immune system, such as human immunodeficiency virus (HIV) or hepatitis B or C, or an auto-immune disorder requiring systemic cytotoxic or immunosuppressive therapy. Note: Participants that are currently using inhaled, intranasal, ocular, topical or other non-oral or non-intravenous (IV) steroids are not necessarily excluded from the study but need to be discussed with the study chair.
  • Participants with uncontrolled infection or other uncontrolled systemic illness.
  • Female participants of childbearing potential must not be pregnant or breast-feeding. Female participants of childbearing potential must have a negative serum or urine pregnancy test prior to the start of therapy (as clinically indicated).
  • Active illicit drug use or diagnosis of alcoholism
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition as the agents used in study
  • Evidence of disseminated disease, including diffuse leptomeningeal disease or evidence of CSF dissemination
  • Known additional malignancy that is progressing or requires active treatment within 3 years of start of study drug
  • Concomitant use of potent CYP3A4/5 inhibitors during the treatment phase of the study and within 72 hours prior to starting study drug administration.
  • Concomitant use of potent CYP3A4/5 inducers, which include enzyme inducing antiepileptic drugs (EIAEDs), during the treatment phase of the study and within 2 weeks prior to starting treatment. Concurrent corticosteroids is allowed.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ARM 2: ONC201 (Day -1), Radiation+ONC201, Paxalisib+ONC201
Patients may receive a safety lead in of ONC201. During the trial validation phase, patients without prior biopsy receive ONC201 PO on day -1 prior to standard of care biopsy. During the radiation/re-irradiation phase, patients without prior radiation therapy or have disease progression after radiation therapy undergo weekly radiation therapy and receive ONC201 PO weekly during radiation therapy. During the maintenance phase, patients receive ONC201 PO weekly and paxalisib PO daily (QD). Cycles repeat every 28 days (4 weeks) in the absence of adverse events of unacceptable toxicity
Radiation: Radiation Therapy
Undergo radiation therapy
Other Names:
  • Radiotherapy
Drug: ONC201
Given orally (PO)
Other Names:
  • TIC10
  • Antagonist of dopamine receptor D2 (DRD2) and caseinolytic protease proteolytic subunit (ClpP)
Drug: Paxalisib
Given PO
Other Names:
  • Inhibitor of the PI3K/AKT/mTOR pathway
  • GDC-0084
  • GDC0084
  • PI3K Inhibitor GDC-0084
Experimental: ARM 4: ONC201 (Day -1,-2), Radiation+ONC201, Paxalisib+ONC201
Patients may receive a safety lead in of ONC201. During the trial validation phase, patients without prior biopsy receive ONC201 PO on days -2 and -1 prior to standard of care biopsy. During the radiation/re-irradiation phase, patients may receive ONC201 PO weekly during radiation therapy. During the maintenance phase, patients receive ONC201 PO weekly and paxalisib PO QD. Cycles repeat every 28 days (4 weeks) in the absence of adverse events or unacceptable toxicity
Radiation: Radiation Therapy
Undergo radiation therapy
Other Names:
  • Radiotherapy
Drug: ONC201
Given orally (PO)
Other Names:
  • TIC10
  • Antagonist of dopamine receptor D2 (DRD2) and caseinolytic protease proteolytic subunit (ClpP)
Drug: Paxalisib
Given PO
Other Names:
  • Inhibitor of the PI3K/AKT/mTOR pathway
  • GDC-0084
  • GDC0084
  • PI3K Inhibitor GDC-0084
Experimental: ARM 6: Paxalisib (Day -1), Radiation+Paxalisib , Paxalisib+ONC201
Patients may receive a safety lead in of ONC201. During trial validation phase, patients without prior biopsy receive paxalisib PO on day -1 prior to standard of care biopsy. During the radiation/re-irradiation phase, patients without prior radiation therapy or have disease progression after radiation therapy undergo weekly radiation therapy and receive paxalisib PO daily during radiation therapy. During the maintenance phase, patients receive ONC201 PO weekly and paxalisib PO QD. Cycles repeat every 28 days (4 weeks) in the absence of adverse events of unacceptable toxicity
Radiation: Radiation Therapy
Undergo radiation therapy
Other Names:
  • Radiotherapy
Drug: ONC201
Given orally (PO)
Other Names:
  • TIC10
  • Antagonist of dopamine receptor D2 (DRD2) and caseinolytic protease proteolytic subunit (ClpP)
Drug: Paxalisib
Given PO
Other Names:
  • Inhibitor of the PI3K/AKT/mTOR pathway
  • GDC-0084
  • GDC0084
  • PI3K Inhibitor GDC-0084

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival at 6 months (PFS6) - Cohorts 1A, 1B, 2A, 2B Only
Time Frame: 6 months after administration of ONC201 in the maintenance phase
Percentage of participants alive and free from progression at 6 months after the initiation of the combination of the backbone (i.e., ONC201) with a novel agent given in the maintenance phase of therapy. The primary analysis for PFS6 is based on the intention to treat (ITT) population, according to treatment arm assignment. PFS6 is estimated using the Kaplan-Meier method with exact confidence intervals for each cohort and arm. Participants with unknown progression status at 6 months are considered failures (i.e., progressed) for the PFS6 analysis.
6 months after administration of ONC201 in the maintenance phase
Overall survival at 7 months (OS7) - Cohort 3A & 3B Only
Time Frame: 7 months after administration of ONC201 in the maintenance phase
OS7 is defined as the percentage of participants alive at 7 months after the initiation of the combination of the backbone (i.e., ONC201) with a novel agent given in the maintenance phase of therapy. The primary analysis for OS7 is based on the ITT population, according to treatment arm assignment. OS7 is estimated using the Kaplan-Meier method with exact confidence intervals for each cohort and arm. Participants with unknown survival status at 7 months are considered failures (i.e., dead) for the OS7 analysis.
7 months after administration of ONC201 in the maintenance phase

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)
The Chad-Tough Defeat DIPG Foundation
Mithil Prasad Foundation
Storm the Heavens Fund

Investigators

  • Principal Investigator: Sabine Mueller, MD, PhD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2021

Primary Completion (Anticipated)

December 31, 2025

Study Completion (Anticipated)

June 30, 2027

Study Registration Dates

First Submitted

August 10, 2021

First Submitted That Met QC Criteria

August 10, 2021

First Posted (Actual)

August 18, 2021

Study Record Updates

Last Update Posted (Actual)

May 15, 2023

Last Update Submitted That Met QC Criteria

May 11, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200821
  • NCI-2021-08386 (Registry Identifier: NCI Clinical Trials Reporting Program (CTRP))
  • 1R01NS124607-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data after de-identification.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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