Study of Ribociclib and Everolimus in HGG and DIPG or Ribociclib and Temozolomide in DHG, H3G34-mutant

May 27, 2026 updated by: Nationwide Children's Hospital

Phase 2 Study of Ribociclib-Containing Post-Radiotherapy Combinations in Pediatric and Young Adult Patients Newly Diagnosed With High-Grade Glioma, Including Diffuse Intrinsic Pontine Glioma: Ribociclib and Everolimus for HGG/DIPG Which Harbor Alterations of the Cell Cycle and/or PI3K/mTOR Pathways AND Ribociclib and Temozolomide for DHG, H3G34-mutant

The goal of this study is to determine the efficacy of the 1) ribociclib and everolimus to treat pediatric and young adult patients newly diagnosed with a high-grade glioma (HGG), including DIPG, that have genetic changes in pathways (cell cycle, PI3K/mTOR) that these drugs target or 2) ribociclib and temozolomide to treat pediatric and young adult patients newly diagnosed with diffuse hemispheric glioma (DHG), H3G34-mutant.

The main question the study aims to answer is whether the combinations of ribociclib and everolimus or ribociclib and temozolomide can prolong the life of patients diagnosed with HGG/DIPG or DHG H3G34-mutant.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a multicenter, international, phase 2 study of post-radiotherapy (RT) combination of ribociclib and everolimus to treat pediatric, adolescent, and young adult patients newly diagnosed with HGG and DIPG that harbor alterations of the cell cycle and/or PI3K/mTOR pathways to assess treatment efficacy (Stratum A-D Part 2). The study will include a feasibility cohort (Strata A-D, Part 1) to identify the dose of ribociclib PfOS (Powder for Oral Suspension) that is safe and tolerable in combination with everolimus. Efficacy for Strata A-D Part 2 study will be defined by progression-free survival (PFS; HGG [stratum A]) and Overall Survival (OS; DIPG [stratum B]), with key longitudinal biomarker correlatives. Outcomes among patients with primary thalamic, spinal cord, and/or secondary (radiation related) HGG (strata C) will be descriptively analyzed. Objective radiographic response rates and agent-specific toxicities will also be assessed, with a feasibility cohort to determine the recommended phase 2 dose (RP2D) of the combination of ribociclib and everolimus in patients with metastatic disease who received upfront craniospinal irradiation (stratum D).

The study was amended in October 2025 to also include an additional stratum, Stratum E, which will serve patients with localized DHG, H3G34-mutant with the combination of ribociclib and temozolomide. As most DHG, H3G34-mutant tumors are MGMT promoter methylated and receive temozolomide as part of standard of care, we are studying the adjuvant combination of ribociclib and temozolomide following upfront RT. Stratum E will open with a Phase 1 Run-In to determine the RP2D of ribociclib PfOS formulation in combination with temozolomide in patients newly-diagnosed with DHG, H3G34-mutant post-RT, with PK testing. Once the RP2D is determined, patients with localized DHG, H3G34-mutant will be enrolled on the Stratum E efficacy expansion cohort to descriptively assess survival outcomes, with similar longitudinal biomarker correlatives to the other strata.

Protocol therapy with the maintenance combination of either 1) ribociclib and everolimus or 2) ribociclib and temozolomide must begin no later than 35 calendar days post-completion of RT. The earliest patients can begin protocol treatment is 28 calendar days post-completion of RT. Each cycle will be 28 days in duration and treatment can continue up to a total of 26 cycles. For Strata A-D, Ribociclib will be given orally once daily for 3 weeks (days 1-21), with one week off. Everolimus will be given orally daily continuously (days 1-28). For Stratum E, Ribociclib will be given orally once daily for 3 weeks (days 1-21), and temozolomide will be given days 1-5 for the first 13 cycles (Year 1), and ribociclib alone will be given orally once daily for 3 weeks (days 1-21) for the subsequent 13 cycles (Year 2).

Study Type

Interventional

Enrollment (Estimated)

120

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
    • New South Wales
      • Randwick, New South Wales, Australia, 2031
        • Recruiting
        • Sydney Children's Hospital
        • Contact:
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
    • Victoria
      • Melbourne, Victoria, Australia, 3052
    • Western Australia
      • Perth, Western Australia, Australia, 6000
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G1X8
        • Not yet recruiting
        • The Hospital for Sick Children (SickKids)
        • Contact:
    • Quebec
      • Montreal, Quebec, Canada, H4A3J1
        • Not yet recruiting
        • Montreal Children's Hospital
        • Contact:
  • Germany
    • Baden-Wurttemberg
      • Heidelberg, Baden-Wurttemberg, Germany, 69120
        • Not yet recruiting
        • Hopp Children's Cancer Center at NCT Heidelberg (KiTZ)
        • Contact:
  • New Zealand
    • Grafton
      • Auckland, Grafton, New Zealand, 1023
        • Not yet recruiting
        • Starship Children's Hospital
        • Contact:
  • United Kingdom
      • London, United Kingdom, WC1N 3JH
        • Not yet recruiting
        • Great Ormond Street Hospital
        • Contact:
  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Ann & Robert H. Lurie Children's Hospital of Chicago
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Not yet recruiting
        • Dana-Farber Cancer Institute
        • Contact:
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • C.S. Mott Children's Hospital
        • Contact:
    • North Carolina
      • Durham, North Carolina, United States, 27708
        • Recruiting
        • Duke University Health System
        • Contact:
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Children's Hospital Medical Center
        • Contact:
      • Columbus, Ohio, United States, 43235
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Not yet recruiting
        • Children's Hospital of Philadelphia
        • Contact:
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Texas Children's Hospital
        • Contact:
    • Washington
      • Seattle, Washington, United States, 98105

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

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

TarGeT-A study strata definitions Part1: Initial Feasibility Study for the combination of ribociclib PfOS formulation with everolimus: Enrollment on this cohort will be limited to patients aged <21 years with primary intracranial localized HGG and DIPG

Part 2

  • Stratum A: Patients with localized, intracranial, non-pontine, and non-thalamic HGG (who do not meet criteria for strata C-D)
  • Stratum B: Patients with DIPG
  • Stratum C: Patients with primary thalamic, spinal cord, and/or secondary/radiation-related HGG.
  • Stratum D: Patients with metastatic/disseminated HGG, multifocal HGG, and/or gliomatosis cerebri who received CSI.

Stratum E

  • Stratum E: Patients with localized DHG, H3G34-mutant.

Inclusion Criteria:

  1. Inclusion criteria already met to enroll on TarGeT-SCR (central molecular and histopathologic screening) based on:

    1.1) Age: patients must be ≥12 months and ≤39 years of age at the time of enrollment on TarGeT-SCR. For the Part 1 Initial Feasibility Cohort (receiving ribociclib and everolimus) only: patients must be <21 years of age at the time of enrollment on this protocol.

    1.2) Diagnosis: patients with newly-diagnosed HGG, including DIPG are eligible. All patients must have histologic confirmation tumor tissue from diagnostic biopsy or resection, without exceptions. The diagnosis of HGG, including DIPG, must have been confirmed through TarGeT-SCR:

    • For the diagnosis of DIPG, patients must have a tumor with pontine epicenter and diffuse involvement of at least 2/3 of the pons, with histopathology, consistent with diffuse WHO grade 2-4 glioma
    • All other HGGs must be WHO grade 3 or 4.

    1.3) Disease status: There are no disease status requirements for enrollment

    • Patients without measurable disease are eligible.
    • Patients with metastatic or multifocal disease or gliomatosis cerebri who received upfront CSI are eligible
    • Patients with a primary spinal HGG are eligible
    • Patients with secondary, radiation-related HGG are eligible.
  2. Inclusion criteria for assignment to TarGeT-A, for all strata:

2.1) Presence of at least one relevant actionable somatic alteration, detailed here:

  • Pathogenic alterations presumed to cause activation of cell cycle:
  • Amplification of CDK4 or CDK6
  • Deletion of CDKN2A, CDKN2B, or CDKN2C
  • Amplification of CCND1 or CCND2
  • Pathogenic alterations presumed to cause activation of the PI3K/mTOR pathway:
  • Deletion or mutation of PTEN
  • Mutation or amplification of PIK3CA
  • Mutation of PIK3R1
  • Deletion or mutation of TSC1 or TSC2
  • Patients with evidence of homozygous (biallelic) RB1 loss by sequencing are excluded from TarGeT-A
  • Patients whose tumors harbor other alterations suspected to activate the cell cycle and/or PI3K/mTOR pathway could potentially also be eligible, but only following consensus recommendation by the international multidisciplinary molecular screening committee.
  • For Stratum E: H3G34 (R/V) mutation

2.2) Performance Level: Karnofsky ≥ 50% for patients > 16 years of age and Lansky ≥ 50 for patients ≤ 16 years of ag. 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.

2.3) Prior Therapy for HGG:

  • Surgery, RT, dexamethasone are permissible. Temozolomide administered concurrently with RT is permissible. Avastin/bevacizumab use is permitted given the last dose was administered > 21 days prior to enrollment. No other prior anticancer therapy for HGG will be allowed.
  • Patients must have received photon or proton RT.
  • Patients must have started RT < 42 calendar days from initial diagnosis defined as the date of diagnostic biopsy or resection. If a patient underwent 2 upfront surgeries (e.g., biopsy then resection or debulking), this is the date of the second surgery.
  • RT delivered via photon or proton beam, must have been administered at a standard dose including (54 Gy in 30 fractions for DIPG, 54-59.4 Gy in 30-33 fractions), 45 Gy-54 Gy for primary spinal disease, and/or 36 Gy-39.6 Gy craniospinal for patients with spinal or leptomeningeal metastatic disease with supplemental boost to 45-54 Gy for metastasis within the thecal sac and 54 Gy-60 Gy for intracranial metastasis. Any variances in the radiotherapy dose within 10% of the standard doses outlined above will be discussed with the Sponsor-Investigator to confirm eligibility prior to study enrollment.
  • Patients must enroll and start treatment No later than 35 calendar days post-completion of RT. The earliest patients can begin protocol treatment is 28 calendar days post-completion of RT.

2.4) Organ Function Requirements

2.4.1) Adequate Bone Marrow Function Defined as:

  • Peripheral absolute neutrophil count (ANC) ≥ 1000/mm3
  • Platelet count ≥ 100,000/mm3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
  • Hemoglobin >8 g/dL (may be transfused)

2.4.2) Adequate Renal Function Defined as:

  • Creatinine clearance or radioisotope GFR ≥ 70ml/min/1.73 m2 OR
  • Maximum serum creatinine based on (Schwartz et al. J. Peds, 106:522, 1985) age/gender as follows: 1 to < 2 years=0.6 mg/dL for males and females; 2 to < 6 years=0.8 mg/dL for males and females; 6 to < 10 years= 1.0 mg/dL for males and females; 10 to < 13 years=1.2 mg/dL for males and females. 13 to < 16 years=1.5 mg/dL for males and 1.4 mg/dL for females.

2.4.3) Adequate Liver Function Defined as:

  • Total bilirubin must be ≤ 1.5 times institutional upper limit of normal for age
  • AST(SGOT)/ALT(SGPT) ≤ 3 times institutional upper limit of normal
  • Serum albumin ≥ 2g/dL

2.4.4) Adequate Cardiac Function Defined as:

  • Ejection fraction of ≥ 50% by echocardiogram
  • QTc ≤ 450 msec (by Bazett formula)

2.4.5) Adequate Neurologic Function Defined as: Patients with seizure disorder may be enrolled if well-controlled on anticonvulsants that are not strong inducers or inhibitors of CYP3A4/5.

2.4.6) Adequate Pulmonary Function Defined as: No evidence of dyspnea at rest, and a pulse oximetry >94% on room air if there is clinical indication for determination.

2.5) Ability to take medications by mouth: For ribociclib and everolimus strata, patients must be able to take study medications by mouth as administration via NG/NJ/G tube is not allowed.

2.6) Informed Consent: 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

2.7) Contraception: Male and female patients of childbearing potential must be willing to use a highly effective contraception method.

Exclusion Criteria

  1. Pregnant or Breast-Feeding Pregnant or breast-feeding women will not be entered on this study due to known potential risks of fetal and teratogenic adverse events as seen in animal/human studies. Pregnancy tests must be obtained in girls who are post-menarchal. Patients of childbearing or child fathering potential must agree to use at least one highly effective method of contraception while being treated on this study and for 3 months after completing therapy. A woman is considered of childbearing potential if she is fertile, following menarche and until becoming post-menopausal unless permanently sterile. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. A man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy. Male participants should refrain from sperm donation throughout the duration of treatment and for 3 months after completion of therapy

    A highly effective contraception method is defined as one that results in a low failure rate (<1% per year) when used consistently and correctly. The following are considered highly effective contraception methods:

    • Combined estrogen and progesterone containing hormonal contraception associated with inhibition of ovulation.
    • Progesterone-only hormonal contraception associated with inhibition of ovulation.
    • Intra Uterine Device (IUD)
    • Intra Uterine hormone releasing system
    • Bilateral tubal occlusion
    • Vasectomized partner
    • Sexual abstinence (avoiding having heterosexual intercourse) The following contraceptive measures are NOT considered effective
    • Progesterone-only hormonal contraception (birth control pill) that that does NOT stop ovulation
    • Male or female condom with or without spermicide
    • Cap, diaphragm or sponge with spermicide

  2. Concomitant Medications

    • Patients receiving corticosteroids are eligible. The use of corticosteroids must be reported.
    • Patients who are currently receiving another investigational drug are not eligible.
    • Patients who are currently receiving other anti-cancer agents are not eligible, with the exception of temozolomide given concurrently with RT only.
    • Patients who are receiving enzyme inducing anticonvulsants that are strong inducers or inhibitors of CYP3A4/5 are not eligible.
    • Patients who are receiving strong inducers or inhibitors of CYP3A4/5 are not eligible and should be avoided from 14 days prior to enrollment to the end of the study.
    • Patients who are receiving medications known to prolong QTc interval are not eligible.
    • Patients who are receiving therapeutic anticoagulation with warfarin or other coumadin-derived anticoagulants are not eligible. Therapy with heparin, low molecular weight heparin (LMWH), or fondaparinux is allowed as long as the patient has adequate coagulation defined as aPTT < 1.5Xs ULN and INR < 1.5.
  3. Patients who have an uncontrolled infection are not eligible.
  4. 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.
  5. Patients with known clinically significant active malabsorption syndrome or other condition that could affect absorption are not eligible.
  6. Patients with prior or ongoing clinically significant medical or psychiatric condition that, in the investigator's opinion, could affect the safety of the subject, or could impair the assessment of study results are not eligible.

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stratum A (n=40)
Patients with localized, intracranial, non-pontine, and non-thalamic HGG (who do not meet criteria for strata B, C, or D).
Drug: Ribociclib
Ribociclib PO qd on days 1-21
Other Names:
  • Kisqali
Drug: Everolimus
Everolimus PO qd on days 1-28
Other Names:
  • Afinitor
Experimental: Stratum B (n=40)
Patients with DIPG, defined as a tumor with pontine epicenter and diffuse involvement of at least 2/3 of the pons, with histopathology consistent with diffuse WHO grade 2-4 glioma (e.g., diffuse astrocytoma, anaplastic astrocytoma, glioblastoma, H3K27-altered diffuse midline glioma).
Drug: Ribociclib
Ribociclib PO qd on days 1-21
Other Names:
  • Kisqali
Drug: Everolimus
Everolimus PO qd on days 1-28
Other Names:
  • Afinitor
Experimental: Stratum C (n=6-12)
Patients with primary thalamic, spinal cord, and/or secondary (radiation-related) HGG.
Drug: Ribociclib
Ribociclib PO qd on days 1-21
Other Names:
  • Kisqali
Drug: Everolimus
Everolimus PO qd on days 1-28
Other Names:
  • Afinitor
Experimental: Stratum D (n=6-12)
Patients with metastatic/disseminated HGG, multifocal HGG, and/or gliomatosis cerebri who received craniospinal irradiation.
Drug: Ribociclib
Ribociclib PO qd on days 1-21
Other Names:
  • Kisqali
Drug: Everolimus
Everolimus PO qd on days 1-28
Other Names:
  • Afinitor
Experimental: Stratum E (n=20)
Patients with localized H3G34-mutant DHG
Drug: Ribociclib
Ribociclib PO qd on days 1-21
Other Names:
  • Kisqali
Drug: Temozolomide (TMZ)
Temozolomide PO qd on days 1-5 for the first 13 cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS) in HGG (Part 2, Stratum A)
Time Frame: From date on treatment until date of Progressive Disease or death due to any cause or date of last follow-up, assessed up to 60 months
To assess the efficacy of ribociclib and everolimus in pediatric and young adult patients newly diagnosed with HGG by estimating the distribution of PFS compared to molecularly-stratified and matched historical controls.
From date on treatment until date of Progressive Disease or death due to any cause or date of last follow-up, assessed up to 60 months
Overall Survival (OS) in DIPG (Part 2, Stratum B)
Time Frame: From date on treatment until date of death due to any cause or date of last follow-up, assessed up to 60 months
To assess the efficacy of ribociclib and everolimus in pediatric and young adult patients newly diagnosed with DIPG by estimating the distribution of OS compared to molecularly-stratified and matched historical controls.
From date on treatment until date of death due to any cause or date of last follow-up, assessed up to 60 months
Establish MTD and RP2D of ribociclib and everolimus (Part 2, Stratum D)
Time Frame: Completion of Cycle 1 (28 days)
To identify the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of the combination of ribociclib and everolimus given to patients with metastatic HGG who have received craniospinal irradiation CSI.
Completion of Cycle 1 (28 days)
Number of participants with ribociclib and everolimus-related adverse events as assessed by CTCAE v5.0 (Part 1- initial feasibility study)
Time Frame: Completion of Cycle 1 (28 days)
Identify the safe dose of ribociclib powder for oral solution (PfOS) formulation in combination with everolimus that is feasible in pediatric patients with newly-diagnosed HGG, including DIPG, with cell cycle and/or PI3K/mTOR pathway alterations. This will be achieved by calculating the number of participants with, as well as frequency and severity of, ribociclib and everolimus-related Adverse Events as assessed by CTCAE v5.0 in the first 6-12 patients enrolled
Completion of Cycle 1 (28 days)
Establish RP2D of ribociclib and temozolomide (Phase 1 Run-In Stratum E)
Time Frame: Completion of Cycle 1 (28 days)
Establish RP2D of ribociclib and temozolomide (Phase 1 Run-In Stratum E) Description: To identify the Recommended Phase 2 Dose (RP2D) of the combination of ribociclib and temozolomide given to patients with newly diagnosed localized DHG, H3G34-mutant who have received RT.
Completion of Cycle 1 (28 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival in HGG
Time Frame: From date on treatment until date of death due to any cause or date of last follow-up, assessed up to 60 months
Determine distribution of OS for pediatric and young adult patients newly-diagnosed with HGG which harbor cell cycle and/or PI3K/mTOR pathway alterations treated with post-RT ribociclib and everolimus.
From date on treatment until date of death due to any cause or date of last follow-up, assessed up to 60 months
Number of participants with ribociclib and everolimus-related adverse events as assessed by CTCAE v5.0
Time Frame: From Day 1 of protocol treatment through 30 days following end of protocol treatment
Assess and further characterize the safety and toxicity of post-RT combination of ribociclib and everolimus in pediatric and young adult patients newly diagnosed with HGG, including DIPG. This will be achieved by calculating the number of participants with, as well as frequency and severity of, ribociclib and everolimus-related Adverse Events as assessed by CTCAE v5.0.
From Day 1 of protocol treatment through 30 days following end of protocol treatment
Evaluate Health-Related Quality of Life Outcomes
Time Frame: At the end of every other Cycle (each cycle is 28 days)
Evaluate health-related quality of life outcomes of pediatric and young adult patients newly-diagnosed with either 1) HGG, including DIPG, or 2) DHG, H3G34-mutant treated with combination of ribociclib and everolimus or ribociclib and temozolomide, by patient and/or parent reporting at key timepoints in therapy using the patient reported outcomes measurement information system (PROMIS) survey.
At the end of every other Cycle (each cycle is 28 days)
Overall Survival in DHG, H3G34-mutant
Time Frame: From date on treatment until date of death due to any cause or date of last follow-up, assessed up to 60 months
Determine distribution of OS for pediatric and young adult patients newly-diagnosed with DHG, H3G34-mutant treated with post-RT ribociclib and temozolomide.
From date on treatment until date of death due to any cause or date of last follow-up, assessed up to 60 months
Number of participants with ribociclib and temozolomide-related adverse events as assessed by CTCAE v5.0
Time Frame: From Day 1 of protocol treatment through 30 days following end of protocol treatment
Assess and further characterize the safety and toxicity of post-RT combination of ribociclib and temozolomide in pediatric and young adult patients newly diagnosed with DHG, H3G34-mutant. This will be achieved by calculating the number of participants with, as well as frequency and severity of, ribociclib and temozolomide-related Adverse Events as assessed by CTCAE v5.0.
From Day 1 of protocol treatment through 30 days following end of protocol treatment

Collaborators and Investigators

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

Sponsor

Nationwide Children's Hospital

Collaborators

Novartis

Investigators

  • Principal Investigator: Maryam Fouladi, MD, Nationwide Children's Hospital
  • Study Chair: Margot Lazow, MD, Nationwide Children's Hospital

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)

August 22, 2024

Primary Completion (Estimated)

August 31, 2029

Study Completion (Estimated)

August 28, 2034

Study Registration Dates

First Submitted

April 20, 2023

First Submitted That Met QC Criteria

May 2, 2023

First Posted (Actual)

May 6, 2023

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CONNECT TarGeT-A
  • R01FD008167 (U.S. FDA Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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