The Expanded Access Use of Vorasidenib in Patients With IDH1 or IDH2 Mutated Glioma or for Participants in Japan With Diffuse Glioma With IDH1 or IDH2 Mutations Who Have Undergone Surgery as Their Only Treatment
试验速览
- 阶段
- 不适用
- 状态
- Approved For Marketing
- 发起方
- Servier
研究概览
简要总结
This is an expanded access program to provide vorasidenib for treatment of patients 12 years or older with IDH1- or IDH2-mutated glioma.
For participants in Japan, DIM-95032-001-JPN will provide access to vorasidenib for Japanese participants aged 12 years and older with IDH1- or IDH2-mutant diffuse glioma who have undergone surgery as their only treatment and have no immediate need for radiotherapy and/or chemotherapy. Participants will receive vorasidenib once daily as long as they continue to see a benefit, do not experience unacceptable reactions, and vorasidenib is not commercially available by prescription. Enrollment will continue until vorasidenib is commercially available in Japan or until the study closes. Participants will transition off the study within approximately 3 months after vorasidenib becomes commercially available by prescription with local reimbursement (price listing) in Japan. A final safety follow-up visit is conducted 30 days after the last dose of treatment on the study.
详细描述
This section does not apply to participants in Japan.
This expanded access program is designed to provide access to vorasidenib for patients with IDH1- or IDH2-mutated glioma who are not eligible for other vorasidenib clinical trials, and who in the opinion of the treating oncologist would potentially benefit from treatment with vorasidenib.
Safety assessments (including vital signs, hematology, and serum chemistry) occur every two weeks for the first two cycles (28 day each cycle), then monthly for the duration of treatment. Treatment with vorasidenib will continue until, in the clinical judgement of the treating physician, the patient is no longer benefiting from the treatment, vorasidenib is approved and available by prescription, or the study is terminated.
Requests by treating physicians to file a single patient investigational new drug application as part of the expanded access program for vorasidenib will be considered on a case-by-case basis.
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and females; ages ≥ 12 years old.
- •IDH-mutant oligodendroglioma or astrocytoma with the IDH1 or IDH2 gene mutation confirmed by tissue-based diagnosis.
- •At least 1 prior surgery for glioma (including biopsy).
- •Adequate bone marrow function as evidenced by:
- •Absolute neutrophil count ≥ 1.5 X 109/L
- •Hemoglobin ≥ 9 g/dL
- •Platelets ≥ 100 X 109/L
- •Adequate hepatic function as evidenced by:
- •Serum total bilirubin ≤ 1.5 X upper limit of normal (ULN)
- •Aspartate aminotransferase and alanine aminotransferase: at or below the ULN
- •Alkaline phosphatase ≤ 2.5 X ULN
- •Adequate renal function as evidenced by a creatinine clearance (CrCl) ≥ 40 mL/min
- •For participants in Japan, all the above inclusion criteria apply, as well as #7 and #8 below:
- •Have no immediate need of radiotherapy/chemotherapy as judged by the treating physician
- •Be able to understand and willing to sign informed consent/assent as determined by local requirements
排除标准
- •Patient is eligible for a clinical trial with vorasidenib.
- •Patients who are enrolled in a Servier-sponsored clinical trial and have completed all requirements of the trial may be eligible if the patient continues to benefit from vorasidenib and does not meet criteria for discontinuation of treatment.
- •Pregnant or breastfeeding.
- •Patients who require or who cannot withhold strong inhibitors of CYP1A2 (ciprofloxacin and fluvoxamine). Consider alternative therapies that are not strong CYP1A2 inhibitors.
- •For participants in Japan, the above exclusion criteria do NOT apply. The applicable exclusion criteria for Japan are listed as #13 through #18 below:
- •Are participating in another investigational or interventional clinical trial
- •Have had any prior anticancer therapy other than surgery for treatment of glioma including systemic chemotherapy, radiotherapy, IDH inhibitors, and other anticancer therapies (investigational agents)
- •Are pregnant or breast feeding
- •Are men or women who will not agree to use highly effective forms of contraception during the trial
- •Have Grade 4 astrocytoma
- •Are taking strong CYP1A2 inhibitors like fluvoxamine maleate (Luvox, Depromel), etc