NL-OMON53539招募中2 期
PNOC022: 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 - PNOC022, DMG-ACT
Prinses Máxima Centrum voor Kinderoncologie0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 64（—）
入选标准
- •Cohort 1A and 1B (participants with newly diagnosed DMG prior to radiation
- •-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; WHO Grade 3 and 4 H3 wildtype gliomas.
- •Cohort 2A and 2B (participants with DMG who have completed radiation therapy)
- •-Diagnosis of DMG with imaging and/or pathology consistent with a DMG,
- •including spinal cord tumors, who have completed 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 3 and 4 H3 wildtype gliomas.
- •-Participants must be within 4-14 weeks of completion of radiation.
- •Cohort 3A and 3B (participants with DMG at progression)
- •-Diagnosis of recurrent DMG with imaging and/or pathology consistent with a
- •DMG, including spinal cord tumors, who have completed 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 3 and 4 H3 wildtype gliomas.
- •-Participants must have evidence of progression and not have received any
- •treatment for this progression and have not previously received re-irradiation.
- •All Cohorts
- •-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 (21 days for bevacizumab when used for tumordirected
- •therapy, guidance on use for pseudoprogression is below), or 4 weeks (or 5
- •halflives, whichever is shorter) from other anti-tumor therapies.
- •o 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.
- •o 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 MRI scan.
- •-The participant must have adequate organ function (see protocol for details;
- •protocol v3.0 dd 26JAN2023
排除标准
- •Cohort 1A and 1B (participants with newly diagnosed DMG prior to radiation
- •-Prior exposure to radiation therapy.
- •-Thalamic H3K27M DMG*
- •Cohort 2A and 2B
- •-For tumors that do not have a pontine or spinal cord epicenter the following
- •specific exclusion criteria apply:
- •--Thalamic H3K27M DMG that has undergone standard radiation without concurrent
- •therapy (other than temozolomide)*
- •Cohort 1A and 2A (participants with newly diagnosed DMG prior to radiation
- •therapy and who have not previously undergone tumor tissue collection prior to
- •study entry)
- •-Deemed not appropriate for tissue resection/biopsy.
- •Cohort 3A and 3B (participants with DMG at progression)
- •-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.*
- •All Cohorts
- •-Diagnosis of a histone H3 wildtype Grade 2 diffuse astrocytoma
- •-Investigational Drugs
- •o 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
- •-Anti-cancer Agents
- •o Participants who are currently receiving other anti-cancer agents.
- •-Participants with a known disorder that affects their immune system, such as
- •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-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
- •-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 multi-focal disease, 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; see Appendix I), during the treatment phase of the
- •study and within 2 weeks prior to starting treatment. Concurrent
- •corticosteroids is allowed.
- •*Exclusion criteria do not apply to patient of <=18 years old who have thalamic
- 另有 4 项未显示
研究者
相似试验
进行中（未招募）
1 期
Research into a new treatment for children and young adults with diffuse midline gliomaEUCTR2022-000636-40-NLPacific Pediatric Neuro-Oncology Consortium (PNOC)324
招募中
1 期
PNOC022: 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 ProgressioDiffuse Midline Gliomas (DMGs) including Diffuse Intrinsic Pontine Gliomas (DIPGs)MedDRA version: 25.1Level: LLTClassification code: 10087678Term: Diffuse midline glioma H3K27M mutation Class: 100000004848MedDRA version: 21.1Level: PTClassification code: 10065443Term: Malignant glioma Class: 100000004864MedDRA version: 21.0Level: LLTClassification code: 10080666Term: Diffuse intrinsic pontine glioma Class: 10029104MedDRA version: 20.0Level: PTClassification code: 10006143Term: Brain stem glioma Class: 100000004864CTIS2023-507598-16-00Prinses Maxima Centrum voor Kinderoncologie B.V.324
进行中（未招募）
1 期
A Phase 2 Trial of Combination Therapies with Adagrasib in Patients with Advanced Non-Small Cell Lung Cancer with KRAS G12C MutatioAdvanced Non-Small Cell Lung CancerMedDRA version: 21.1Level: PTClassification code: 10061873Term: Non-small cell lung cancer Class: 100000004864CTIS2023-503714-77-00Mirati Therapeutics Inc.137
进行中（未招募）
不适用
A phase II clinical trial on the combination of dabrafenib and trametinib for BRAF-inhibitor pretreated patients with advanced BRAF V600 mutant melanomaadvanced BRAF V600 mutant melanomaMedDRA version: 16.1Level: PTClassification code 10025671Term: Malignant melanoma stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 16.1Level: PTClassification code 10025670Term: Malignant melanoma stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 16.1Level: HLTClassification code 10027156Term: Skin melanomas (excl ocular)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 16.1Level: PTClassification code 10066600Term: Melanoma recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 16.1Level: PTClassification code 10027480Term: Metastatic malignant melanomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2013-004966-33-BEZ Brussel
未知
3 期
Clinical investigation for combination therapy of KAD-1229 and Pioglitazone.Type 2 diabetesJPRN-jRCT2080220136KISSEI PHARMACEUTICAL CO.,LTD.