EUCTR2021-000708-39-DE进行中（未招募）1 期
Phase I/II trial of meclofenamate in progressive MGMT-methylated glioblastoma under temozolomide second-line therapy - MecMeth/ NOA-24
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 72
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.First relapse after first-line therapy with radiotherapy (RT) and alkylating chemotherapy, > 3 months after last chemotherapy application and >6 months after end of RT. Drug therapy and/or radiothera-py for first relapse treatment not yet started.
- •2.Tumor progression according to RANO criteria
- •3.Written informed consent
- •4.Cognitive state to understand rationale and necessity of study therapy and procedures
- •5.MGMT promotor-methylated (MGMTmeth), IDH wildtype glioblastoma (GBM) or gliosarcoma con-firmed with histology of the primary resection or, in phase II, last resection
- •6.age > 18 years
- •7.Karnofsky performance score (KPS) =60%;
- •8.Life expectancy > 6 months
- •9.Adequate bone marrow reserve (WBC >3 G/nl, platelets >100 G/nl)
- •10.Adequate liver function (bilirubin <1.5 x ULN; ASAT /ALAT <3 x ULN, creatinine < 1.5 x ULN)
- •11.Patient compliance and geographic proximity that allow adequate follow up
- •12.Male and female patients with reproductive potential must use an approved contraceptive method during and for 3 months after the trial (Pearl index <1%)
- •13.Pre-menopausal female patients with childbearing potential: a negative serum pregnancy test (beta-HCG) must be obtained prior to treatment start
- •Additional inclusion criterion ONLY for phase I:
- •14.Resection at first relapse not yet performed; according to the local treating neurosurgeon and the documented decision of local neurooncological tumor board, reresection of the tumor is clinically indicated and can be safely de-ferred until day 7-10 after initiation of MFA/TMZ therapy.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 58
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 14
排除标准
- •1.Indication for hematotoxicity in first-line therapy not allowing TMZ starting dose 150 mg/m2/d
- •2.History of skin or liver toxicity >CTCAE5 grade 1 in first-line therapy
- •3.History of gastrointestinal bleeding or gastroduodenal ulcer, active gastritis
- •4.History of asthma, urticaria or allergic-type skin reactions to NSAID
- •5.Prior malignancy other than glioma
- •6.History of confirmed or suspected hypersensitivity (delayed type and immediate type, inclusive of anaphylactic reaction) to any background/ standard TMZ drug product or one of its ingredients of the chosen product, or to cyclooxygenase inhibitors (NSAIDs”), or to any ingredient of meclofenamate drug product
- •7.History of disease with poor prognosis
- •8.History of severe coronary heart disease (esp. after coronary artery bypass graft or history of myocardial infarction) or severe heart failure
- •9.Known HIV infection, active hepatitis B or C
- •10.Breastfeeding or pregnant
- •11.Unable to undergo contrast-enhanced MRI (i.e. contrast allergy, implants, etc).
- •12.Treatment in another clinical trial with therapeutic medical intervention or use of any other investiga-tional agent during the trial or within the 30 days before enrollment
- •13.Medication with a drug that is not allowed in conjunction with MFA intake and cannot be discontin-ued: i.e. lithium, methotrexate, etc.
- •14.Patients with active bleeding, bleeding diathesis, antiplatelet therapy or anticoagulant therapy except for the following anticoagulants which are permitted for low-dose thrombosis prophylaxis up to the dosage specified here: unfractionated heparin 7,500 IU BID or 5,000 IU TID; low molecular weight heparin e. g. enoxa-parin 40 mg/d; fondaparinux 2.5 mg/d; danaparoid sodium 750 IU BID; argatroban IV route throm-bin time < 70 s; dabigatran 110 mg BID; rivaroxaban 10 mg/d; edoxaban 30 mg/d; epixaban 2.5 mg BID This restriction is due to a potentially increased risk of GI ulcers with subsequent bleeding under MFA therapy
- •15.Patients with medically diagnosed hereditary Galactose Intolerance, complete lactase deficiency or confirmed Glucose-Galactose-Malabsortion
- •16.Medical History of gastrointestinal Resection of any kind that may potentially alter the absorption of the investigational study drug, according to investigators judgement
- •17.The presence of any other concomitant severe, progressive, or uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac (including coronary artery bypass graft), or psychiatric disease, or signs and symptoms thereof, that may affect the subjects participation in the study, according to investigators judgement
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