EUCTR2021-000248-23-IT进行中（未招募）1 期
TALAPRO-3: A PHASE 3, RANDOMIZED, DOUBLE-BLIND, STUDY OF TALAZOPARIB WITH ENZALUTAMIDE VERSUS PLACEBO WITH ENZALUTAMIDE IN MEN WITH DDR GENE MUTATED METASTATICCASTRATION-SENSITIVE PROSTATE CANCER - TALAPRO-3
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- PFIZER INC
- 入组人数
- 550
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
- Male
入选标准
- •Participants are eligible to be included in the study only if all of the following criteria apply:
- •Age and Sex:
- •1.Male participants at least 18 years of age at screening. Refer to Appendix 4 of the protocol for reproductive criteria for male participants.
- •Type of Participant and Disease Characteristics:
- •2.Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell or signet cell features. If the participant does not have a prior histological diagnosis, a baseline de novo biopsy must
- •be used to confirm the diagnosis and may also be used to support biomarker analysis.
- •3.Confirmation of DDR gene mutation status by prospective or historical analysis (with sponsor pre-approval) of blood (liquid biopsy) and/or de novo or archival tumor tissue using FoundationOne Liquid CDx or
- •FoundationOne CDx.
- •4.Willing to provide tumor tissue when available (de novo or archived) for retrospective molecular profiling analysis, if not already provided as part of inclusion criterion 3.
- •5.Unless prohibited by local regulations or ethics committee decision, consent to a saliva sample collection for retrospective sequencing of the same DDR genes tested on tumor tissue and blood (liquid biopsy), or a
- •subset thereof, and to serve as a germline control in identifying tumor mutations.
- •6.Surgically or medically castrated, with serum testosterone =50 ng/dL (=1.73 nmol/L) at screening. Ongoing ADT with a GnRH agonist or antagonist for participants who have not undergone bilateral
- •orchiectomy must be initiated at least 4 weeks before randomization and must continue throughout the study.
- •7.Metastatic prostate cancer documented by positive bone scan (for bone disease) or metastatic lesions on CT or MRI scan (for soft tissue).
- •For complete list see section 5.2. of the protocol study
- •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 143
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 407
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •Medical Conditions:
- •1.Other acute or chronic medical (concurrent disease, infection or comorbidity) or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality thatinterferes with a participant's ability to participate in the study, may increase the risk of associated with study participation or study treatment administration, or may interfere with the interpretation of study results, and, in the investigator's judgment, make the participant inappropriate for entry into the study.
- •2.History of seizure or any condition (as assessed by investigator) that may predispose to seizure (eg, prior cortical stroke, significant brain trauma), including any history of loss of consciousness or transient
- •ischemic attack within 12 months of randomization.
- •3.Major surgery (as defined by the investigator) within 2 weeks before randomization.
- •4.Known or suspected brain metastasis or active leptomeningeal disease.
- •5.Symptomatic or impending spinal cord compression or cauda equina syndrome.
- •6.Any history of MDS, AML, or prior malignancy except for the following:
- •Carcinoma in situ or non-melanoma skin cancer.
- •A cancer diagnosed and treated =3 years before randomization with no subsequent evidence of recurrence.
- •American Joint Committee on Cancer Stage 0 or Stage 1 cancer <3 years before randomization that has a remote probability of recurrence in the opinion of the investigator and the sponsor.
- •7.In the opinion of the investigator, any clinically significant gastrointestinal disorder affecting absorption.
- •For a complete list please see section 5.2 of the protocol study
研究者
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