이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

새로 진단되고 재발한 교모세포종에서 다중 요법을 평가하기 위한 시험 (GBM AGILE)

2026년 10월 29일 업데이트: Global Coalition for Adaptive Research

GBM AGILE: 글로벌 적응 시험 마스터 프로토콜: 새로 진단되고 재발하는 GBM에서 여러 요법을 평가하도록 설계된 국제적이고 원활한 2/3상 반응 적응형 무작위 플랫폼 시험

Glioblastoma (GBM) adaptive, global, innovative learning environment (GBM AGILE) is an international, seamless Phase II/III response adaptive randomization platform trial designed to evaluate multiple therapies in newly diagnosed (ND) and recurrent GBM.

All institutions are enrolling Newly Diagnosed participants. Institutions also enrolling Recurrent participants are marked with an asterisk (*).

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

Glioblastoma (GBM) adaptive, global, innovative learning environment (GBM AGILE) is an international, seamless Phase II/III response adaptive randomization platform trial designed to evaluate multiple therapies in newly diagnosed (ND) and recurrent GBM. Its goals are to identify effective therapies for glioblastoma and match effective therapies with patient subtypes. Bayesian response adaptive randomization is used within subtypes of the disease to assign participants to Arms based on their performance. The primary endpoint is overall survival (OS).

GBM AGILE is designed to efficiently evaluate therapies. The trial will be conducted under a single Master Investigational New Drug Application/Clinical Trial Application and Master Protocol, allowing multiple drugs and drug combinations from different pharmaceutical companies to be evaluated simultaneously. The plan is to add experimental therapies as new information about promising new drugs are identified and remove therapies as they complete their evaluation.

연구 유형

중재적

등록 (추정된)

2250

단계

  • 2 단계
  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

  • 독일
      • Cologne, 독일, 50937
        • 모병
        • Uniklinik Koeln - Zentrum fuer Neurologie und Psychiatrie
        • 연락하다:
        • 수석 연구원:
          • Norbert Galldiks, Prof.
      • Frankfurt, 독일, 60528
        • 모병
        • Dr. Senckenbergisches Institut für Neuroonkologie
        • 연락하다:
        • 수석 연구원:
          • Michael Ronellenfitsch, MD, PhD
      • Heidelberg, 독일, 69120
        • 모병
        • Universitätsklinik Heidelberg
        • 수석 연구원:
          • Antje Wick, MD
        • 연락하다:
      • Mannheim, 독일, 68167
        • 모병
        • Universitaetsklinikum Heidelberg - Neurologische Klinik
        • 수석 연구원:
          • Michael Platten, MD
        • 연락하다:
      • Regensburg, 독일, 93053
        • 모병
        • Universitätsklinikum Regensburg
        • 수석 연구원:
          • Peter Hau, MD
        • 연락하다:
      • Tübingen, 독일, 72076
        • 모병
        • Universitätsklinikum Tübingen
        • 수석 연구원:
          • Ghazaleh Tabatabai, MD
        • 연락하다:
  • 미국
    • Alabama
      • Birmingham, Alabama, 미국, 35249
        • 모병
        • University of Alabama at Birmingham
        • 수석 연구원:
          • Louis B Nabors, MD
        • 연락하다:
        • 연락하다:
    • California
      • La Jolla, California, 미국, 92093
      • Los Angeles, California, 미국, 90048
        • 모집하지 않고 적극적으로
        • Cedars Sinai - Samuel Oschin Comprehensive Cancer Institute
      • Los Angeles, California, 미국, 90095
        • 모집하지 않고 적극적으로
        • University of California, Los Angeles
      • Orange, California, 미국, 92868
        • 모병
        • St. Joseph Hospital
        • 수석 연구원:
          • Lars Anker, MD
        • 연락하다:
      • San Francisco, California, 미국, 94143
        • 모병
        • University of California, San Francisco
        • 수석 연구원:
          • Nicholas Butowski, MD
        • 연락하다:
      • Stanford, California, 미국, 94305
        • 완전한
        • Stanford Cancer Center
    • Colorado
      • Aurora, Colorado, 미국, 80045
        • 모병
        • University of Colorado Denver
        • 수석 연구원:
          • Denise Damek, MD
        • 연락하다:
    • Connecticut
      • New Haven, Connecticut, 미국, 06511
        • 모병
        • Yale Cancer Center / Smilow Cancer Hospital*
        • 수석 연구원:
          • Nicholas Blondin, MD
        • 연락하다:
    • Florida
      • Jacksonville, Florida, 미국, 32224
        • 완전한
        • Mayo Clinic Cancer Center
      • Miami, Florida, 미국, 33136
        • 모병
        • Sylvester Comprehensive Cancer Center*
        • 수석 연구원:
          • Macarena I De La Fuente, MD
        • 연락하다:
      • Tampa, Florida, 미국, 33612
        • 모병
        • Moffitt Cancer Center
        • 수석 연구원:
          • Patrick Grogan, MD
        • 연락하다:
        • 연락하다:
    • Georgia
      • Atlanta, Georgia, 미국, 30309
        • 모집하지 않고 적극적으로
        • Piedmont Atlanta Hospital
      • Atlanta, Georgia, 미국, 30322
        • 모집하지 않고 적극적으로
        • Winship Cancer Institute of Emory University
    • Louisiana
      • New Orleans, Louisiana, 미국, 70112
        • 완전한
        • LSU Health Sciences Center - New Orleans
    • Massachusetts
      • Boston, Massachusetts, 미국, 02114
        • 모병
        • Massachusetts General Hospital
        • 수석 연구원:
          • Patrick Wen, MD
        • 연락하다:
          • Patrick Wen, MD
          • 전화번호: 617-726-5130
          • 이메일: pwen@mgb.org
      • Boston, Massachusetts, 미국, 02115
    • Michigan
      • Detroit, Michigan, 미국, 48202
        • 완전한
        • Henry Ford Health System
    • Minnesota
      • Minneapolis, Minnesota, 미국, 55407
        • 모병
        • Allina Health Systems/Abbott Northwestern Hospital
        • 수석 연구원:
          • Andrea Wasilewski, MD
        • 연락하다:
      • Rochester, Minnesota, 미국, 55905
        • 완전한
        • Mayo Clinic Cancer Center - Rochester
    • Mississippi
      • Jackson, Mississippi, 미국, 39213
        • 완전한
        • University of Mississippi Medical Center
    • Missouri
      • St Louis, Missouri, 미국, 63110
        • 완전한
        • Washington University School of Medicine - Siteman Cancer Center
    • New York
      • New York, New York, 미국, 10032
        • 모병
        • Columbia University Medical Center
        • 수석 연구원:
          • Andrew Lassman, MD
        • 연락하다:
      • New York, New York, 미국, 10016
        • 모집하지 않고 적극적으로
        • Perlmutter Cancer Center, NYU Langone Health
      • New York, New York, 미국, 10029
        • 모집하지 않고 적극적으로
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, 미국, 10065
        • 모병
        • Memorial Sloan Kettering Cancer Center*
        • 수석 연구원:
          • Ingo Mellinghoff, MD
        • 연락하다:
        • 연락하다:
    • North Carolina
      • Durham, North Carolina, 미국, 27710
        • 모집하지 않고 적극적으로
        • Duke University Medical Center
      • Winston-Salem, North Carolina, 미국, 272157
        • 모병
        • Comprehensive Cancer Center of Wake Forest*
        • 수석 연구원:
          • Glenn Lesser, MD
        • 연락하다:
    • Ohio
      • Cleveland, Ohio, 미국, 44195
        • 모병
        • Cleveland Clinic
        • 수석 연구원:
          • Mina Lobbous, MD
        • 연락하다:
        • 연락하다:
      • Cleveland, Ohio, 미국, 44106
      • Columbus, Ohio, 미국, 43210
        • 모집하지 않고 적극적으로
        • Ohio State University Cancer Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, 미국, 19104
        • 모집하지 않고 적극적으로
        • University of Pennsylvania - Perelman Center for Advanced Medicine
      • Pittsburgh, Pennsylvania, 미국, 15232
        • 모집하지 않고 적극적으로
        • University of Pittsburgh Medical Center - Hillman Cancer Center
      • Pittsburgh, Pennsylvania, 미국, 15212
        • 완전한
        • Allegheny General Hospital
    • South Carolina
      • Charleston, South Carolina, 미국, 29425
        • 모병
        • Medical University of South Carolina - Hollings Cancer Center
        • 수석 연구원:
          • Scott Lindhorst, MD
        • 연락하다:
    • Texas
      • Austin, Texas, 미국, 78705
        • 모집하지 않고 적극적으로
        • Texas Oncology - Austin
      • Dallas, Texas, 미국, 75390
        • 모집하지 않고 적극적으로
        • University of Texas Southwestern Medical Center
      • Houston, Texas, 미국, 77030
        • 모집하지 않고 적극적으로
        • University of Texas - MD Anderson Cancer Center
    • Utah
      • Salt Lake City, Utah, 미국, 84112
        • 모병
        • University of Utah - Huntsman Cancer Institute
        • 수석 연구원:
          • Howard Colman, MD, PhD
        • 연락하다:
        • 연락하다:
    • Virginia
      • Charlottesville, Virginia, 미국, 22908
        • 모병
        • University of Virginia Health
        • 연락하다:
        • 수석 연구원:
          • David Schiff, MD
    • Washington
      • Seattle, Washington, 미국, 98101
        • 모집하지 않고 적극적으로
        • University of Washington Medical Center
    • Wisconsin
      • Milwaukee, Wisconsin, 미국, 53226
        • 모병
        • Froedtert Hospital/Medical College of Wisconsin
        • 수석 연구원:
          • Jennifer Connelly, MD
        • 연락하다:
        • 연락하다:
  • 스위스
      • Zurich, 스위스
        • 모병
        • University Hospital Zurich
        • 수석 연구원:
          • Michael Weller, MD
        • 연락하다:
    • Canton of Vaud
      • Lausanne, Canton of Vaud, 스위스, 1011
        • 모병
        • Centre Hospitalier Universitaire Vaudois Lausanne
        • 수석 연구원:
          • Andreas Hottinger, MD
        • 연락하다:
  • 캐나다
    • Ontario
      • Toronto, Ontario, 캐나다, M4N 3M5
      • Toronto, Ontario, 캐나다, M5G 2C1
        • 모병
        • Princess Margaret Cancer Centre
        • 수석 연구원:
          • Warren Mason, MD
        • 연락하다:
        • 연락하다:
    • Quebec
      • Montreal, Quebec, 캐나다, H3A 2B4
        • 모집하지 않고 적극적으로
        • Montreal Neurological Institute and Hospital, McGill University
      • Sherbrooke, Quebec, 캐나다, J1H 5H3
        • 모집하지 않고 적극적으로
        • Université de Sherbrooke
  • 프랑스
      • Bron, 프랑스, 69677
        • 모병
        • Centre Hospitalier Lyon Sud / Hôpital Neurologique P. Wertheimer
        • 수석 연구원:
          • Francois Ducray, MD
        • 연락하다:
      • Marseille, 프랑스, 13005
        • 모병
        • Hopital de la Timone
        • 연락하다:
        • 수석 연구원:
          • Emelie Tabouret, MD
      • Paris, 프랑스, 75013
        • 모병
        • Hopital Piti-Salpetriere
        • 연락하다:
        • 수석 연구원:
          • Mehdi Touat, MD
  • 호주
    • New South Wales
      • St Leonards, New South Wales, 호주, 2065
        • 모병
        • Northern Sydney Cancer Centre/Royal North Shore Hospital
        • 수석 연구원:
          • Helen Wheeler, MD
        • 연락하다:
      • Waratah, New South Wales, 호주, 2298
        • 모집하지 않고 적극적으로
        • Calvary Mater Newcastle
    • Queensland
      • Herston, Queensland, 호주, 4029
        • 모병
        • Royal Brisbane and Women's Hospital
        • 수석 연구원:
          • Zarnie Lwin, MD
        • 연락하다:
    • South Australia
      • Bedford Park, South Australia, 호주, 5042
    • Victoria
      • Heidelberg, Victoria, 호주, 3084
      • Melbourne, Victoria, 호주
        • 모병
        • Peter MacCallum Cancer Centre
        • 수석 연구원:
          • Jim Whittle, MD
        • 연락하다:
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Newly Diagnosed Inclusion Criteria:

  • Age ≥ 18 years.
  • Histologically confirmed Grade IV GBM, inclusive of gliosarcoma (WHO criteria; IDH wild-type by immunohistochemistry [IHC] or sequencing for IDH) established following either a surgical resection or biopsy. An MRI scan with the required imaging sequences performed within 21 days prior to randomization preferably. The post-operative MRI scan performed within 96 hours of surgery or the MRI scan performed for radiation therapy planning may serve as the MRI scan performed during screening if all required imaging sequences were obtained.
  • Karnofsky performance status ≥ 60% performed within a 14-day window prior to randomization.
  • Availability of tumor tissue representative of GBM from definitive surgery or biopsy.

Recurrent Inclusion Criteria:

  • Age ≥ 18 years.
  • Histologically confirmed Grade IV GBM, inclusive of gliosarcoma (WHO criteria; IDH wild-type by immunohistochemistry [IHC] or sequencing for IDH) at first or second recurrence after initial standard, control or experimental therapy that includes at a minimum radiation therapy (RT).
  • Evidence of recurrent disease demonstrated by disease progression using slightly modified Response Assessment in Neuro-Oncology (RANO) criteria.
  • Two scans to confirm progression are required: at least 1 scan at the time of progression and 1 scan prior to the time of progression.
  • Karnofsky performance status ≥ 70% performed within a 14-day window prior to randomization.
  • Availability of tumor tissue representative of GBM from initial definitive surgery and/or, recurrent surgery, if performed.

Newly Diagnosed Exclusion Criteria:

  • Received any prior treatment for glioma including: a. Prior prolifeprospan 20 with carmustine wafer. b. Prior intracerebral, intratumoral, or cerebral spinal fluid (CSF) agent. c. Prior radiation treatment for GBM or lower-grade glioma. d. Prior chemotherapy or immunotherapy for GBM or lower-grade glioma. Receiving additional, concurrent, active therapy for GBM outside of the trial.
  • Extensive leptomeningeal disease.
  • QTc > 470 msec
  • History of another malignancy in the previous 2 years, with a disease-free interval of < 2 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible.

Recurrent Exclusion Criteria:

  • Early disease progression prior to 3 months (12 weeks) from the completion of RT.
  • More than 2 prior lines for chemotherapy administration. (NOTE: In the 1st line adjuvant setting, combination of temozolomide (TMZ) with an experimental agent, is considered one line of chemotherapy.)
  • Received any prior treatment with lomustine, agents part of any of the experimental arms, or bevacizumab or other vascular endothelial growth factor (VEGF) or VEGF receptor-mediated targeted agent.
  • Any prior treatment with prolifeprospan 20 with carmustine wafer.
  • Any prior treatment with an intracerebral agent.
  • Receiving additional, concurrent, active therapy for GBM outside of the trial
  • Extensive leptomeningeal disease.
  • QTc > 470 msec
  • History of another malignancy in the previous 2 years, with a disease-free interval of < 2 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 순차적 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: Control Arm

Newly Diagnosed GBM: Radiation therapy (XRT) 60 Gy for 6 weeks. Temozolomide 75 mg/m2 orally daily during radiation therapy. Rest Period 2-6 weeks from the last day of radiation, and the start of the first cycle of Maintenance Therapy 2-6 weeks after the last day of radiotherapy. The start of all subsequent maintenance therapy cycles (2-12) every 4 weeks + 7 days after the first daily dose of temozolomide of the preceding cycle. Total number of cycles should comply with institutional or country standards. During maintenance therapy, the first cycle of temozolomide will be at 150 mg/m2 for Days 1-5 of a 28-day cycle. Second and subsequent cycles of maintenance therapy will be at 200 mg/m2 for Days 1-5 of a 28-day cycle.

Recurrent GBM: Lomustine started at 110 mg/m2/day on Day 1 of a 42-day cycle as per local standards. Treatment will continue for up to 6 total cycles.
의약품: Temozolomide

Dosage Form: Capsule for oral administration Strengths: 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg

다른 이름들:
  • 테모다르
  • 테모달
  • 템캐드
의약품: Lomustine

Dosage Form: Capsule for oral administration Strength: 5 mg, 10 mg, 40 mg, and 100 mg

다른 이름들:
  • CCNU
  • 씨뉴
  • 글레오스틴
방사능: Radiation

60 Gy
실험적: Regorafenib Treatment Arm- Enrollment concluded

Newly Diagnosed MGMT Unmethylated GBM: XRT 60 Gy for 6 weeks. Temozolomide 75 mg/m2 orally daily during radiation therapy. Rest Period 4 weeks from the last day of radiation. Maintenance period: Regorafenib (Dosage Form: Tablet for oral administration; Strength: 40 mg) 160 mg orally (PO) every day (QD) for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off).

Recurrent GBM: Regorafenib (Dosage Form: Tablet for oral administration; Strength: 40 mg) 160 mg orally (PO) every day (QD) for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off).
의약품: Regorafenib

Dosage Form: Tablet for oral administration Strength: 40 mg Standard Regimen: 160 mg orally (PO) every day (QD) for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off)

다른 이름들:
  • 베이 73-4506
  • 스티바르가
실험적: Paxalisib Treatment Arm- Enrollment concluded

Newly Diagnosed MGMT Unmethylated GBM: XRT 60 Gy for 6 weeks. Temozolomide 75 mg/m2 orally daily during radiation therapy. Rest Period 4 weeks from the last day of radiation. Maintenance period: Paxalisib (Dosage Form: Tablet for oral administration; Strength: 15 mg per tablet) 45 mg orally (PO) every day for 28 days for the first cycle. If tolerated, increase dose to 60 mg orally (PO) every day for 28 days for all subsequent cycles.

Recurrent GBM: Paxalisib (Dosage Form: Tablet for oral administration; Strength: 15 mg per tablet) 45 mg orally (PO) every day for 21 days for the first cycle. If tolerated, increase dose to 60 mg orally (PO) every day for 21 days for all subsequent cycles.
의약품: Paxalisib

Dosage Form: Tablet for oral administration Strength: 15 mg Standard Regimen: 45 mg orally (PO) every day for 28 days for the first cycle. If tolerated, increase dose to 60 mg orally (PO) every day for 28 days for all subsequent cycles

다른 이름들:
  • GDC-0084
실험적: VAL-083 Treatment Arm- Enrollment concluded

Newly Diagnosed MGMT Methylated and Unmethylated GBM: XRT 60 Gy for 6 weeks. Temozolomide 75 mg/m2 orally daily during radiation therapy. Rest Period 4 weeks from the last day of radiation. Maintenance period: VAL-083 (Dosage Form: Infusion for intravenous administration; Strength: 30 mg/m2) on Day 1, 2 and 3 of 21-day cycle.

Recurrent GBM: VAL-083 (Dosage Form: Infusion for intravenous administration; Strength: 30 mg/m2) on Day 1, 2 and 3 of 21-day cycle.
의약품: VAL-083

Dosage Form: Infusion for intravenous administration Strength: 40 mg per vial Standard Regimen: 30 mg/m2 on Day 1, 2 and 3 of 21-day cycle. The drug is available in powder form. It is reconstituted with 5 mL of 0.9% Sodium Chloride for Injection, USP. This will produce a solution of 40 mg VAL-083 in 5 mL. The required volume of reconstituted VAL-083 for the patient is then calculated at the rate of 30 mg/m2. The corresponding volume is further diluted into 250 mL of 0.9% Sodium Chloride for Injection, USP, prior to intravenous administration.

다른 이름들:
  • 디안히드로갈락티톨
실험적: VT1021 Treatment Arm - Dose Finding Phase

Newly diagnosed MGMT Methylated and Unmethylated GBM: Rolling 6 design. Treatment as outlined in section "Experimental: VT1021 Treatment Arm" with the first 6 patients receiving VT1021 at 12 mg/kg twice weekly in combination with temozolomide and radiation therapy. If there are two dose limiting toxicities reported, the dose will be de-escalated to 9 mg/kg two times a week. 6 patients will then be receiving 9 mg/kg two times a week and observed for DLTs for 4 weeks.

Recurrent GBM: Dose Finding Phase is not applicable for patients with Recurrent GBM in the VT1021 treatment arm.
의약품: VT1021

Dosage Form: Infusion for intravenous administration Strength: 10 mg/mL Standard Regimen Newly Diagnosed: Dose as confirmed through the dose finding phase, administered twice weekly (Mon and Thurs or Tues and Fri or Mon and Fri).

Standard Regimen Recurrent: 12 mg/kg administered twice weekly (Mon and Thurs or Tues and Fri or Mon and Fri). The drug is available as a sterile solution of the acetate salt formulated with phosphate-buffered saline, mannitol, and 2.5% polysorbate 80. The required volume stock solution for the patient is calculated. The corresponding volume is diluted in 500 mL of either 0.9% saline or D5W, prior to intravenous administration.
실험적: VT1021 Treatment Arm - Enhanced Safety Management (ESM)

Experimental: VT1021 Treatment Arm - Enhanced Safety Management (ESM) Newly diagnosed MGMT Methylated and Unmethylated GBM: Supplemental safety assessments including bi-weekly collection of adverse events, dose modification profile, hematology, serum chemistry and coagulation panels. PK and PD assessments are done for patients as a part of ESM. ESM will continue until the Data Safety Monitoring Board (DSMB) suspends collection of additional data.

Recurrent GBM: ESM is not applicable for patients with Recurrent GBM in the VT1021 treatment arm.
의약품: VT1021

Dosage Form: Infusion for intravenous administration Strength: 10 mg/mL Standard Regimen Newly Diagnosed: Dose as confirmed through the dose finding phase, administered twice weekly (Mon and Thurs or Tues and Fri or Mon and Fri).

Standard Regimen Recurrent: 12 mg/kg administered twice weekly (Mon and Thurs or Tues and Fri or Mon and Fri). The drug is available as a sterile solution of the acetate salt formulated with phosphate-buffered saline, mannitol, and 2.5% polysorbate 80. The required volume stock solution for the patient is calculated. The corresponding volume is diluted in 500 mL of either 0.9% saline or D5W, prior to intravenous administration.
실험적: VT1021 Treatment Arm

Newly diagnosed MGMT Methylated and Unmethylated GBM: XRT 60 Gy for 6 weeks. Temozolomide 75 mg/m2 orally daily and VT1021 (Dosage Form: Infusion for intravenous administration; Strength: 10 mg/mL; Dose: As confirmed through the dose finding phase) twice weekly during radiation therapy. Rest period: 2-6 weeks from last day of radiation. VT1021 dosing will continue during the rest period. Maintenance period: The first cycle of temozolomide will be at 150 mg/m2 for days 1-5 of a 28-day cycle. Second and subsequent cycles of maintenance therapy will be at 200 mg/m2 for days 1-5 of a 28-day cycle. Temozolomide will be administered for up to 6 cycles in the maintenance phase in combination with VT1021. After 6 cycles, VT1021 only.

Recurrent GBM: VT1021 (Dosage Form: Infusion for intravenous administration; Strength: 10 mg/mL; Dose: 12mg/kg) twice weekly.
의약품: VT1021

Dosage Form: Infusion for intravenous administration Strength: 10 mg/mL Standard Regimen Newly Diagnosed: Dose as confirmed through the dose finding phase, administered twice weekly (Mon and Thurs or Tues and Fri or Mon and Fri).

Standard Regimen Recurrent: 12 mg/kg administered twice weekly (Mon and Thurs or Tues and Fri or Mon and Fri). The drug is available as a sterile solution of the acetate salt formulated with phosphate-buffered saline, mannitol, and 2.5% polysorbate 80. The required volume stock solution for the patient is calculated. The corresponding volume is diluted in 500 mL of either 0.9% saline or D5W, prior to intravenous administration.
실험적: Troriluzole Treatment Arm - Dose Finding Phase

Newly diagnosed MGMT Methylated and Unmethylated GBM: Rolling 6 design. The first 6 patients will receive troriluzole at 100 mg BID for the first two weeks followed by 200 mg BID for the next two weeks in combination with temozolomide and radiation therapy. If there are two dose limiting toxicities (DLTs) reported, the dose will be de-escalated to 100 mg in the morning and followed by 200 mg in the evening. 6 patients will receive this dose and observed for 4 weeks. If there are two DLTs reported, then this dose will be de-escalated to 100 mg BID. 6 patients will then be receiving this dose and observed for DLTs for 4 weeks.

Recurrent GBM: Rolling 6 design. The first 6 patients receiving troriluzole 100 mg twice a day (BID) for the first two weeks followed by 200 mg BID for the next two weeks in combination with lomustine. The dose de-escalation is similar to that of newly diagnosed patients during the rolling 6 design.
의약품: Troriluzole

Dosage Form: Capsule for oral administration Strength: 100 mg Standard Regimen: Dose as confirmed through the dose finding phase orally BID.

다른 이름들:
  • BHV-4157
실험적: Troriluzole Treatment Arm - Enhanced Safety Management (ESM)

Newly diagnosed MGMT Methylated and Unmethylated GBM and Recurrent GBM: Supplemental safety assessments including bi-weekly collection of adverse events, dose modification profile, hematology, serum chemistry and coagulation panels. ESM will continue until the Data Safety Monitoring Board (DSMB) suspends collection of additional data.
의약품: Troriluzole

Dosage Form: Capsule for oral administration Strength: 100 mg Standard Regimen: Dose as confirmed through the dose finding phase orally BID.

다른 이름들:
  • BHV-4157
실험적: Troriluzole Treatment Arm

Newly diagnosed MGMT Methylated and Unmethylated GBM: XRT 60 Gy for 6 weeks. Temozolomide 75 mg/m2 orally daily and troriluzole (Dosage Form: Capsule for oral administration; Strength: 100 mg; Dose: As confirmed by dose finding phase) BID. Rest period: 2-6 weeks from last day of radiation. Troriluzole dosing will continue during the rest period. Maintenance period: The first cycle of temozolomide will be at 150 mg/m2 for days 1-5 of a 28-day cycle. Second and subsequent cycles of maintenance therapy will be at 200 mg/m2 for days 1-5 of a 28-day cycle. Temozolomide will be administered for up to 6 cycles in the maintenance phase in combination with troriluzole. After 6 cycles, troriluzole only.

Recurrent GBM: Lomustine 100 mg/m2 orally on day 1 of a 42-day cycle in combination with troriluzole (Dosage Form: Capsule for oral administration; Strength: 100 mg; Dose: As confirmed by dose finding phase) BID. After 6 cycles, troriluzole only.
의약품: Troriluzole

Dosage Form: Capsule for oral administration Strength: 100 mg Standard Regimen: Dose as confirmed through the dose finding phase orally BID.

다른 이름들:
  • BHV-4157
실험적: ADI-PEG 20 Treatment Arm - Dose Finding Phase

Newly diagnosed MGMT Methylated and Unmethylated GBM: Dose Finding Phase is not applicable for newly diagnosed patients on the ADI-PEG 20 treatment arm.

Recurrent GBM: Rolling 6 design. The first 6 patients will receive ADI-PEG 20 at 36 mg/m2 once a week in combination with lomustine 100 mg/m2 orally on day 1 of a 42-day cycle. 6 patients will receive this dose and be observed for 4 weeks. If there are two dose limiting toxicities (DLTs) reported, the dose will be de-escalated to 18 mg/m2 once a week. 6 patients will receive this dose and be observed for 4 weeks.
생물학적: ADI-PEG 20

Dosage Form: Solution for intramuscular injection Strength: 11.5 ± 1.0 mg/ml Standard Regimen: For newly diagnosed patients, 36mg/m2. For recurrent disease patients, dose as confirmed through the dose finding phase intramuscularly once a week

다른 이름들:
  • 페가르기미나제
실험적: ADI-PEG 20 Treatment Arm - Enhanced Safety Management (ESM)

Newly diagnosed MGMT Methylated and Unmethylated GBM: ESM is not applicable for newly diagnosed patients on the ADI-PEG 20 treatment arm.

Recurrent GBM: Supplemental safety assessments including bi-weekly collection of adverse events, dose modification profile, hematology, serum chemistry and coagulation panels. ESM will continue until the Data Safety Monitoring Board (DSMB) suspends collection of additional data.
생물학적: ADI-PEG 20

Dosage Form: Solution for intramuscular injection Strength: 11.5 ± 1.0 mg/ml Standard Regimen: For newly diagnosed patients, 36mg/m2. For recurrent disease patients, dose as confirmed through the dose finding phase intramuscularly once a week

다른 이름들:
  • 페가르기미나제
실험적: ADI-PEG 20 Treatment Arm

Newly diagnosed MGMT Methylated and Unmethylated GBM: XRT 60 Gy over 6 weeks. Temozolomide (75 mg/m2 orally daily and ADI-PEG 20 (Dosage Form: Solution for intramuscular injection; Strength: 11.5 ± 1.0 mg/ml; Dose: 36 mg/m2) once a week. Rest period: 2-6 weeks from last day of radiation. ADI-PEG 20 dosing will continue during rest period. Maintenance period: The first cycle of temozolomide will be at 150 mg/m2 for days 1-5 of a 28-day cycle. Subsequent cycles will be at 200 mg/m2 for days 1-5 of a 28-day cycle. Temozolomide will be administered for up to 6 cycles in the maintenance phase in combination with ADI-PEG 20. After 6 cycles, ADI-PEG 20 only for up to 104 weeks of total treatment.

Recurrent GBM: Lomustine 100 mg/m2 orally on day 1 of a 42-day cycle in combination with ADI-PEG 20 (Dosage Form: Solution for IM injection; Strength: 11.5 ± 1.0 mg/ml; Dose: As confirmed by dose finding phase, once a week. After 6 cycles, ADI-PEG 20 only for up to 104 weeks of total treatment.
생물학적: ADI-PEG 20

Dosage Form: Solution for intramuscular injection Strength: 11.5 ± 1.0 mg/ml Standard Regimen: For newly diagnosed patients, 36mg/m2. For recurrent disease patients, dose as confirmed through the dose finding phase intramuscularly once a week

다른 이름들:
  • 페가르기미나제
실험적: AZD1390 Treatment Arm

Newly Diagnosed MGMT Methylated and Unmethylated GBM: XRT 60 Gy for 6 weeks in combination with AZD1390 given on days of radiation followed by 14 days with daily AZD1390. Rest Period 2-4 weeks from the last day of AZD1390. The first cycle of temozolomide will be at 150 mg/m2 for days 1-5 of a 28-day cycle. Second and subsequent cycles of maintenance therapy will be at 200 mg/m2 for days 1-5 of a 28-day cycle, if there is no toxicity. Temozolomide will be administered for up to 6 cycles in the maintenance phase.
의약품: AZD1390

Standard Regimen Newly Diagnosed: Given once daily on days of radiation and once daily for 14 consecutive days after completion of radiation.
실험적: Tinostamustine - Dose finding phase

Newly diagnosed MGMT Methylated and Unmethylated GBM: Tinostamustine Dosage Form: Infusion for intravenous administration; Rolling 6 design. Treatment as outlined in "Investigational: Tinostamustine Treatment Arm" with the first 6 patients receiving Tinostamustine at 80 mg/m2 over 60 minutes with two potential dose de-escalations. If there are two or more dose limiting toxicities at the tested dose, subsequent patients will be enrolled at the next lower dose level (60 mg/m2 and subsequently to 40 mg/m2).

Recurrent GBM: Rolling 6 design. Tinostamustine Dosage Form: Infusion for intravenous administration; Strength: Starting dose 80 mg/m2 on Day 1 of 21-day cycle for up to 12 cycles. The first 6 patients will receive Tinostamustine at 80 mg/m2 over 60 minutes with two potential dose de-escalations if there are two or more dose limiting toxicities at the tested dose, subsequent patients will be enrolled at the next lower dose level (60 mg/m2 and subsequently to 40 mg/m2).
의약품: Tinostamustine

Dosage form: Reconstituted powder for intravenous administration Strength: 2mg/mL Standard Regimen: Dose as confirmed through the dose finding phase, on Day 1 of 21-day cycle for up to 12 cycles in the maintenance phase.

다른 이름들:
  • 에도-S101
실험적: Tinostamustine - Enhanced Safety Management

Newly diagnosed MGMT Methylated and Unmethylated GBM: Treatment as outlined in "Investigational: Tinostamustine Treatment Arm". Dose as determined by the dose finding phase.

Recurrent GBM: Tinostamustine (Dosage Form: Infusion for intravenous administration; Strength: as determined though the dose finding phase on Day 1 of 21-day cycle for up to 12 cycles.
의약품: Tinostamustine

Dosage form: Reconstituted powder for intravenous administration Strength: 2mg/mL Standard Regimen: Dose as confirmed through the dose finding phase, on Day 1 of 21-day cycle for up to 12 cycles in the maintenance phase.

다른 이름들:
  • 에도-S101
실험적: Investigation arm: Tinostamustine

Newly diagnosed MGMT Methylated and Unmethylated GBM: XRT total of 60 Gy (2 Gy/fraction) over 6 weeks. Temozolomide 75 mg/m2 orally daily during radiation therapy. Rest Period 2-6 weeks from the last day of radiation. Tinostamustine treatment period: Tinostamustine (Dosage Form: Infusion for intravenous administration; Strength: as determined though the dose finding phase) on Day 1 of 21-day cycle for up to 12 cycles.
의약품: Tinostamustine

Dosage form: Reconstituted powder for intravenous administration Strength: 2mg/mL Standard Regimen: Dose as confirmed through the dose finding phase, on Day 1 of 21-day cycle for up to 12 cycles in the maintenance phase.

다른 이름들:
  • 에도-S101

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Overall Survival (OS)
기간: From date of randomization until the date of death from any cause, or until 12 months following last patient randomization (approximately 2 years), whichever comes first.

Overall survival is defined from the time of randomization to death from any cause. Patients still alive at the time of an analysis will be considered censored at their date of last contact.
From date of randomization until the date of death from any cause, or until 12 months following last patient randomization (approximately 2 years), whichever comes first.

2차 결과 측정

결과 측정
측정값 설명
기간
Progression-free survival (PFS)
기간: From date of randomization to date of clinically determined progression or date of death from any cause, or until 12 months following last patient randomization (approximately 2 years), whichever comes first.

Progression-free survival is defined as the time from randomization to clinically determined progression or death from any cause. All participants will be included in the analysis of PFS.
From date of randomization to date of clinically determined progression or date of death from any cause, or until 12 months following last patient randomization (approximately 2 years), whichever comes first.
Tumor Response
기간: From initiation of study treatment to date of disease progression, or until 12 months following last patient randomization (approximately 2 years), whichever comes first.

Tumor response is categorized by Complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD). Response captured from initiation of study treatment until disease progression.
From initiation of study treatment to date of disease progression, or until 12 months following last patient randomization (approximately 2 years), whichever comes first.
Duration of Response (CR + PR)
기간: From date of response to date of clinically determined disease progression or date of death from any cause, or until 12 months following last patient randomization (approximately 2 years), whichever comes first.

Duration of response (CR+PR) is defined as time from date of response to date of clinically determined disease progression or death from any cause.
From date of response to date of clinically determined disease progression or date of death from any cause, or until 12 months following last patient randomization (approximately 2 years), whichever comes first.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Global Coalition for Adaptive Research

협력자

Bayer
AstraZeneca
Kazia Therapeutics Limited
Biohaven Pharmaceuticals, Inc.
Kintara Therapeutics, Inc.
Vigeo Therapeutics, Inc.
Polaris Group
Knoa Pharma

수사관

  • 수석 연구원: Tim Cloughesy, MD, GCAR CMO and GBM AGILE Global PI

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2019년 7월 30일

기본 완료 (추정된)

2028년 6월 1일

연구 완료 (추정된)

2030년 6월 1일

연구 등록 날짜

최초 제출

2019년 5월 23일

QC 기준을 충족하는 최초 제출

2019년 5월 30일

처음 게시됨 (실제)

2019년 5월 31일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 2일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 10월 29일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • GCAR-7213

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

IPD 계획 설명

Global Coalition for Adaptive Research (GCAR) is in the planning stages at this time.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다