NL-OMON56287招募中2 期
A Phase I/II Combination Study of NMS-03305293 and Temozolomide in Adult Patients with Recurrent Glioblastoma - Study of NMS-03305293+TMZ in Adult Patients with Recurrent Glioblastoma
erviano Medical Sciences Srl, Italy0 个研究点目标入组 16 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
- 16
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
- 18 至 99（—）
入选标准
- •Patients must meet all of the following inclusion criteria to be eligible for
- •enrollment into the study:
- •1. Histologically confirmed diagnosis of an intracranial diffuse glioma (i.e.
- •diffuse astrocytoma, oligodendroglioma or glioblastoma).
- •2. Patients at first relapse after chemotherapy including temozolomide as long
- •as no more than 12 cycles of temozolomide were administered.
- •3. Patients may have been operated for recurrence. If operated:
- •residual and measurable disease after surgery is not required but pathology
- •must have confirmed tumor recurrence.
- •a post-surgery MRI should be available within 48 hours following surgery.
- •surgery completed at least 2 weeks before enrolment and patient clinical
- •status should not be worsened respect to pre-surgery condition
- •1. Histologically confirmed diagnosis of Glioblastoma, IDH wildtype as per WHO
- •2021 classification, including IDH-wildtype diffuse and astrocytic glioma in
- •adults, if there is microvascular proliferation or necrosis or TERT promoter
- •mutation or EGFR gene amplification or +7/*10 chromosome copy number changes,
- •or c-IMPACT-NOW 3 definition including diffuse astrocytic glioma, IDH-
- •wildtype, with molecular features of glioblastoma, WHO Grade 4. IDH1 status
- •must be assessed locally by immunohistochemistry (IHC). If IHC is performed and
- •is negative, and patient is <55 years old, sequencing or a PCR-based validated
- •test must be performed to exclude other IDH1 or IDH2 most frequent mutations.
- •2. Patients at first relapse after initial standard therapy including
- •temozolomide as long as no more than 6 cycles of temozolomide were administered
- •and provided that patient completed standard of care concurrent temozolomide
- •and the radiation therapy
- •3. Patients may have been operated for recurrence. If operated:
- •residual and measurable disease after surgery is required
- •a post-surgery MRI should be available within 48 hours following surgery.
- •surgery completed at least 2 weeks before enrolment and patient clinical
- •status should not be worsened respect to pre-surgey condition.
- •For Phase I and Phase II
- •4. For non-operated patients, with measurable disease in Phase I and for all
- •patients in Phase II, recurrent disease must be defined by at least one
- •bidimensionally measurable contrast-enhancing lesion with clearly defined
- •margins with minimal diameters of 10 mm, visible on 2 or more axial slices 5 mm
- •apart, based on MRI scan done within two weeks prior to enrolment.
- •5. Patients on steroids should have stable or decreasing dose of steroids for 7
- •days prior to the baseline MRI scan.
- •6. Life expectancy of at least 3 months.
- •7. Able to undergo brain MRI scans with IV gadolinium.
- •8. No evidence of symptomatic and acute intratumoral hemorrhage on MRI.
- •Patients with MRI demonstrating old hemorrhage or subacute blood after a
- •neurosurgical procedure (biopsy or resection) are eligible.
- •9. Sufficient tissue representative of the disease available for central MGMT
- •promoter methylation status (Phase I and II) and IDH status evaluation (Phase
- •10. Male or female patients with age >=18 years.
- •11. ECOG performance status <=2.
- •12. Signed and dated IEC or IRB-approved Informed Consent.
- •13. Resolution of all acute toxic effects (excluding alopecia) of any prior
- •anticancer therapy to NCI CTCAE (Ve
排除标准
- •Patient Exclusion Criteria
- •The presence of any of the following will exclude a patient from study
- •enrollment:
- •1. Current enrollment in another interventional clinical trial.
- •2. Current treatment with other anticancer agents, or treatment at recurrence
- •with carmustine wafer implants and proteasome inhibitors.
- •3. Previous treatment with PCV (procarbazine, lomustine and vincristine) or any
- •of its components, carmustine wafer implants, or bevacizumab.
- •4. Previous treatment with PARP inhibitors.
- •5. Major surgery, other than surgery for recurrent diffuse glioma, within 4
- •weeks prior to treatment.
- •6. Standard radiotherapy within the three months (12 weeks) prior to the
- •diagnosis of progression unless the progression is clearly outside the
- •radiation field (eg, beyond the high-dose region or 80% isodose line) or unless
- •the recurrence is histologically proven.
- •7. Prior radiotherapy with a dose over 65 Gy, stereotactic radiosurgery or
- •brachytherapy, unless the recurrence is histologically proven.
- •8. Use of full-dose anticoagulants unless the INR or aPTT is within therapeutic
- •limits (according to the medical standard in the institution) and the patient
- •has been on a stable dose of anticoagulants for at least two weeks before
- •enrollment.
- •9. Treatment with concomitant medications known to be sensitive substrates of
- •CYP2D6 and CYP2C19 that cannot be replaced with another treatment.
- •10. Treatment with enzyme-inducing anti-epileptic drugs (EIAED). Patients may
- •be on non-EIAED or not be taking any anti-epileptic drugs. Patients previously
- •on EIAED must be fully switched to non- EIAED at least 2 weeks prior to
- •11. Pregnant or breast-feeding women.
- •12. Known hypersensitivity to any component of NMS-03305293 or TMZ drug
- •formulations.
- •13. Known active infections (bacterial, fungal, viral including HIV positivity)
- •requiring systemic treatment.
- •14. Patients with QTc interval >=460 milliseconds for women, >=450 milliseconds
- •for men or with risk factors for torsade de pointes (e.g., uncontrolled heart
- •failure, uncontrolled hypokalemia, history of prolonged QTc interval or family
- •history of long QT syndrome). For patients receiving treatment with concomitant
- •medications known to prolong the QTc interval, replacement with another
- •treatment prior to enrollment is mandatory.
- •15. Active gastrointestinal disease (e.g., documented gastrointestinal ulcer,
- •Crohn*s disease, ulcerative colitis, or short gut syndrome) or other syndromes
- •that would impact on drug absorption.
- •16. Any of the following in the past 6 months: myocardial infarction, unstable
- •angina, coronary/peripheral artery bypass graft, symptomatic congestive heart
- •failure, cerebrovascular accident or transient ischemic attack, active bleeding
- •17. Prior invasive malignancy (except for non melanoma skin cancer, carcinoma
- •in situ or localized cancer) unless the patient has been disease-free and off
- •therapy for that disease for >= 3 years.
- •18. Other severe acute or chronic medical or psychiatric condition or
- •laboratory abnormality that may increase the risk associated with study
- •participation or study drug administration or may interfere with the
- •interpretation of study results and, in the judgment of the Investigator, would
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研究者
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