jRCT2080225115已完成2 期
Phase I/II Clinical Study of OP-10 for Recurrent or Exacerbated Glioma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Multicenter, single-arm, open-label, phase I/II study with central enrollment system
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- No limit 至 No limit（—）
- 性别
- All
入选标准
- •Patients who meet all of the following criteria will be selected.
- •(1) Phase I: Recurrent or exacerbated glioma that is refractory to standard therapy or for which there is no standard therapy, has been diagnosed.
- •Phase II: Recurrent or exacerbated diffuse midline glioma has been diagnosed.
- •(2) Phase I: Age at the time of enrollment is 17 years or older.
- •(3) The body weight allows administration of OP-10 at the dose level of OP-10 at the time of enrollment.
- •(4) Have a history of standard treatment.
- •(5) Lesions in the brain have been confirmed by MRI examination.
- •(6) Phase I: Performance status (Karnofsky scale) is 80% or higher.
- •Phase II: Performance status (Karnofsky scale) is 50% or higher (excluding patients with performance status of 30-40% due to underlying disease).
- •(7) At least 14 days have passed since the last dose of the most recent antineoplastic drug therapy. However, at least 30 days have passed since the last dose of bevacizumab.
- •(8) Phase I: At least 14 days have passed since the last irradiation in the most recent radiotherapy.
- •Phase II: At least 90 days have passed since the last irradiation in the most recent radiotherapy.
- •(9) Capsules can be taken orally.
- •(10) RANO-LGG criteria can be used for evaluation.
- •(11) Steroid dose have been stable or decreasing for at least 3 days prior to MRI at enrollment.
- •(12) Have the following organ functions.
- •[1] Neutrophil count: 1000/uL or more
- •[2] Platelet count: 10x10^4/uL or more
- •[3] Serum creatinine: not over the upper limit of facility standard value
- •[4] Total bilirubin: not more than 1.5 times the upper limit of facility standard value
- •[5] ALT: 110 IU/L or less
- •[6] Serum albumin: 2.5 g/dL or more
- •[7] Hemoglobin: 8.0 g/dL or more
- •(13) If a patient or partner is of childbearing potential, they can agree to use contraception before the start of the trial, during the protocol treatment, and for 180 days after the last administration of OP-
- •(14) Written informed consent to participate in the trial can be obtained from the subject (for subject is 20 years of age or older) or the subject's legally authorized representative (for subject is younger than 20 years of age).
排除标准
- •Patients who meet any of the following criteria will be excluded.
- •(1) Patient who have received prior treatment with OP-
- •(2) A history of hypersensitivity to any of the ingredients of OP-
- •(3) A concurrent infection.
- •(4) Positive HBs antigen blood virological test result at enrollment
- •However, even if the HBs antigen result is negative, patients who are HBc and/or HBs antibody-positive will be excluded (excluding a history of HB vaccination).
- •(5) Positive HCV antibody blood virological test result at enrollment
- •(6) Positive HIV antibody blood virological test result at enrollment
- •(7) A history of cardiac disease (excluding cured congenital diseases).
- •(8) A history of interstitial lung disease
- •(9) Participation in the trial is judged to be difficult due to a concurrent psychiatric disease.
- •(10) Ingestion of drugs, foods or beverages that inhibit CYP3A within 72 hours before administration of OP-10 and during the protocol treatment.
- •(11) Ingestion of drugs, foods or beverages that induce CYP3A within 2 weeks before the start of the trial and during the protocol treatment.
- •(12) Participants in another clinical trial
- •(13) Breastfeeding women (patients who are presently breastfeeding will be excluded, even if they suspend breastfeeding.)
- •(14) Women who are pregnant or suspected of being pregnant
- •(15) Patient who is ineligible for the trial, judged by the investigator or subinvestigator.
研究者
研究点 (1)
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