JPRN-jRCT2031210670暂停2 期
Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study
David Chen0 个研究点目标入组 770 人开始时间: 2022年3月17日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 发起方
- 入组人数
- 770
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
- >= 12age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Histologically or cytologically confirmed diagnosis of advanced and unresectable or metastatic solid malignancy
- •-Measurable disease as defined by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1), Response Assessment in Neuro-Oncology (RANO) criteria, or International Neuroblastoma Response Criteria (INRC)
- •-Performance status as follows: Participantss aged >= 18 years: Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2; Participantss aged 16 to < 18 years: Karnofsky score >= 50%; Participants aged < 16 years: Lansky score >= 50%
- •-For participants aged >= 18 and <18 years: adequate hematologic and end-organ function
- •-Disease progression on prior treatment, or previously untreated disease with no available acceptable treatment
- •-Adequate recovery from most recent systemic or local treatment for cancer
- •-Life expectancy >= 8 weeks
- •-Ability to comply with the study protocol, in the investigator's judgment
- •-RET fusion positivity, as determined by a Clinical Laboratory Improvement Amendments or equivalently certified next generation sequencing (NGS) assay (tissue or blood).
- •-Ability to swallow pralsetinib intact, without chewing, crushing, or opening the capsules
- •-For females of childbearing potential: Negative pregnancy test <= 7 days prior to initiating study treatment; agreement to remain abstinent (refrain from heterosexual intercourse) or use single or combined non-hormonal contraception methods that result in a failure rate of <1% per year during the treatment period and for at least 14 days after the last dose of pralsetinib; and agreement to refrain from donating eggs during this same period
- •Examples of non-hormonal contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, and copper intrauterine devices.
- •-For males: Agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom plus an additional contraception method that together result in a failure rate of <1% per year during the treatment period and for at least 7 days after the last dose of pralsetinib, and agreement to refrain from donating sperm during this same period
排除标准
- •-Current participation or enrollment in another therapeutic clinical trial
- •-Any anticancer treatment within 2 weeks prior to start of study treatment
- •-Whole brain radiotherapy within 14 days prior to start of study treatment
- •-Stereotactic radiosurgery within 7 days prior to start of study treatment
- •-Pregnant or breastfeeding, or intending to become pregnant during the study
- •-History of or concurrent serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe participation in and completion of the study or confounds the ability to interpret data from the study
- •-Incomplete recovery from any surgery prior to the start of study treatment that would interfere with the determination of safety or efficacy of study treatment
- •-Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or higher), myocardial infarction, or cerebrovascular accident within 3 months prior to enrollment, unstable arrhythmias, or unstable angina
- •-History of another active cancer within 5 years prior to screening that may interfere with the determination of safety or efficacy of study treatment with respect to the qualifying solid tumor malignancy
- •-Diagnosis of RET fusion positive NSCLC
- •-Prior treatment with RET inhibitors (approved or investigational)
- •-Symptomatic or actively progressing CNS metastases
- •Asymptomatic patients with treated or untreated CNS metastases are eligible, provided that all of the following criteria are met:
- •-No ongoing requirement for corticosteroids as therapy for CNS metastases
- •-No evidence of interim progression between the completion of CNS-directed therapy and screening radiographic study
- •-No history of intracranial hemorrhage or spinal cord hemorrhage
- •-Clinically symptomatic interstitial lung disease or interstitial pneumonitis, including radiation pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention)
- •-History of pneumonitis during the prior 12 months
- •-Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine) or systemic steroids > 10 mg/day of prednisone (or equivalent)
- •-Active, uncontrolled infection (viral, bacterial, or fungal)
- •-Have a positive hepatitis C virus (HCV) antibody test at screening
- •Patients positive for HCV antibody are eligible only if PCR is negative for HCV RNA.
- •-Have a positive hepatitis B surface antigen (HBsAg) test at screening
- •Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (hepatitis B core antibody [HBcAb] positive, but negative HBsAg) are eligible only if the HBV DNA test is negative.
- •-Have a positive HIV test at screening, with the following exception:
- •Patients with a positive HIV screening are eligible provided they are on stable antiretroviral therapy, have a CD4 count >= 200/uL, and have an undetectable viral load.
- •Sites should include an HIV test during screening, as allowed per local regulations.
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