CTIS2023-508953-16-00进行中（未招募）1 期
A Pilot and Surgical Study of Larotrectinib for Treatment of Children with Newly Diagnosed High-Grade Glioma with NTRK Fusion - CONNECT1903
ationwide Childrens Hospital0 个研究点目标入组 15 人开始时间: 2024年2月22日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 15
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
- 0 至 64（—）
- 性别
- All
入选标准
- •Age: Patients = 21 years of age (birth to 21 years of age excluding preterm newborn infants) at the time of study enrollment will be eligible., Organ function requirement: Adequate neurologic function defined as: ? Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled., 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., Diagnosis: Patients with newly-diagnosed HGG, including DIPG, whose tumors are documented in a CLIA/CAP certified lab (or clinically equivalent method considered standard in non-US sites) to harbor an NTRK fusion alteration by FISH, PCR, or next generation sequencing are eligible. Patients must have had histologically verified HGG such as anaplastic astrocytoma, glioblastoma, or H3 K27-mutant diffuse midline glioma verified at a CONNECT site., Disease status: Patients with disseminated DIPG or HGG are eligible only if the patient is to receive chemotherapy only, i.e. no craniospinal RT is intended to be given. MRI of spine must be performed if disseminated disease is suspected clinically by the treating physicians. Patients with primary spinal tumors are eligible only if the patient is to receive either chemotherapy or focal radiation therapy, i.e. no craniospinal RT is intended to be given. Patients with leptomeningeal disease only, with no definitive identifiable primary tumor, and documented NTRK fusion, must be discussed with the Study Chair on a case-by-case basis., Performance level: Karnofsky = 50% for patients > 16 years of age and Lansky = 50% for patients = 16 years of age. 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., Prior therapy: ? Patients must not have received any prior anti-cancer chemotherapy, ? Prior use of corticosteroids is allowed, Organ function requirement: Adequat bone marrow function defined as: ? Peripheral absolute neutrophil count (ANC) = 1000/mm3, ? Platelet count = 100,000/µL (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment), ? Hemoglobin >8 g/dL (may receive transfusions), Organ function requirement: Adequate renal function defined as: ? Serum creatinine within normal institutional limits, OR ? Creatinine clearance or radioisotope GFR = 70ml/min/1.73 m2, Organ function requirement: Adequate liver function defined as: ? Total bilirubin = 2.5 × institutional upper limit of normal, ? AST(SGOT)/ALT(SGPT) = 2.5 × institutional upper limit of normal, Organ function requirement: Adequate pulmonary function defined as: ? Pulse oximetry > 94% on room air if there is clinical indication for determination (e.g. dyspnea at rest)
排除标准
- •Pregnancy or breast-feeding: Pregnant or breast-feeding women will not be entered on this study due to unknown risks of fetal and teratogenic adverse events as seen in animal/human studies. Pregnancy tests must be obtained in girls who are post-menarchal. Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method., Minors who will not be capable of giving consent when they reach the legal age of majority, Concomitant medications: Investigational Drugs: Patients who have previously received or are currently receiving another investigational drug are not eligible. Anti-cancer Agents: Patients who have previously received or are currently receiving other anti-cancer agents, including chemotherapy, immunotherapy, monoclonal antibodies, biologic or targeted therapy, are not eligible., Infection: Patients must not have any active, uncontrolled systemic bacterial, viral or fungal infection., Patients who have received prior solid organ transplantation are not eligible., Patients must not have malabsorption syndrome or other condition affecting oral absorption., Patients must not be receiving any treatment with a strong cytochrome P450 3A4 (CYP3A4) inhibitor or inducer. Strong inducers or inhibitors of CYP3A4 should be avoided from 7 days prior to enrollment to the end of the study., 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., Patient committed to an institution by virtue of an order issued either by the judicial or the administrative authorities, Patient is dependent on the Sponsor, Investigator or trial site
研究者
相似试验
尚未招募
Unknown
Real world study of lorlatinib in previously untreated ALK positive lung cancerCTRI/2024/03/063721Pfizer Products India Private Limited
尚未招募
不适用
A Registry study of Larotrectinib chemotherapy in patients with NTRK fusion positive recurrent salivary gland cancer as second-line treatmentNeoplasmsKCT0007143Seoul National University Hospital5
进行中（未招募）
2 期
Larotrectinib in Treating Patients With Previously Untreated TRK Fusion Solid Tumors and TRK Fusion Relapsed Acute LeukemiaInfantile FibrosarcomaRecurrent Acute LeukemiaRefractory Acute LeukemiaSolid NeoplasmCentral Nervous System NeoplasmNCT03834961Children's Oncology Group33
进行中（未招募）
不适用
A study of erlotinib (Tarceva®) treatment in patients with locally advanced or metastatic non-small cell lunf cancer who present activating mutations in the tyrosine kinase domain of the epidermal growth factor receptorocally advanced or metastatic non-small cell lung cancer with activating mutations in the tyrosine kinase domain of the epidermal growth factor receptor.MedDRA version: 14.0Level: LLTClassification code 10025054Term: Lung cancer non-small cell stage IIIBSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.0Level: LLTClassification code 10025055Term: Lung cancer non-small cell stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2010-023869-21-FIRoche Oy
进行中（未招募）
1 期
The effect of pre-operative Octreotide LAR treatment on surgical cure rates of subjects with Acromegaly, and post-operative responsiveness to somatostatin analogue treatment in patients not cured surgically. - Pre-operative Octreotide LAR for AcromegalyEUCTR2005-003496-20-GBOxford Radcliffe Hospitals NHS trust