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临床试验/EUCTR2017-003295-31-HU
EUCTR2017-003295-31-HU进行中（未招募）1 期

A Phase 3, Randomized, Double-blind, Placebo-controlled Study Of Talazoparib With Enzalutamide In Metastatic Castration-resistant Prostate Cancer

Pfizer Inc., 235 East 42nd Street, New York, NY 100170 个研究点目标入组 1,037 人开始时间: 2019年4月10日最近更新:
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试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
1,037
研究概览入排标准研究者记录与标识符相似试验

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

  • •Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study:
  • •1. At least 18 years of age. For Japan, at least 20 years of age.
  • •2. Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell or signet cell features. If the patient does not have a prior histological diagnosis, a baseline de novo biopsy must be used to confirm the diagnosis and to support biomarker analysis.
  • •3. Asymptomatic or mildly symptomatic metastatic castration resistant prostate cancer (mCRPC) (score on BPI-SF Question #3 must be <4).
  • •4. For enrollment into Part 2 only (optional in Part 1): assessment of DDR mutation status by prospective analysis of blood (liquid biopsy), or tissue (de novo or archival tissue), or historical analysis (with Sponsor pre-approval), of most recent tumor tissue per FoundationOne testing. (Note: for patients enrolling in Part 1, DDR deficiency testing is optional).
  • •5. For enrollment into Part 2 only (optional for Part 1): 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 androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) agonist or antagonist for patients who have not undergone bilateral orchiectomy must be initiated at least 4 weeks before Day 1 (Part 1) or randomization (Part 2) and must continue throughout the study.
  • •7. Metastatic disease in bone documented on bone scan or in soft tissue documented on CT/MRI scan. Scans obtained as part of standard of care in the 6 weeks (42 days) prior to Day 1 (Part 1) or randomization (Part 2) can be used if they meet study requirements. Measurable soft tissue disease is not required. (Adenopathy below the aortic bifurcation alone does not qualify).
  • •8. Progressive disease at study entry in the setting of medical or surgical castration as defined by 1 or more of the following 3 criteria:
  • •- Prostate specific antigen (PSA) progression defined by rising PSA of at least 2 consecutive rises in most recent PSA to be documented over a reference value (measure 1) taken at least 7 days apart within the last 12 months. If the third PSA measure is not greater than the second measure, a fourth PSA measure is required to be taken and be greater than the second measure. The third (or the fourth) confirmatory PSA should be taken within 4 weeks prior to randomization. The third (or the fourth) PSA value, obtained before randomization must be = 1 µg/L if qualifying only by PSA progression.
  • •- Soft tissue disease progression as defined by RECIST 1.1.
  • •- Bone disease progression defined by Prostate Cancer Working Group 3 (PCWG3) with 2 or more new metastatic bone lesions on a whole body radionuclide bone scan.
  • •9. Ongoing bisphosphonate or denosumab use prior to Day 1 (Part 1) or randomization (Part 2) is allowed but not mandatory.
  • •10. Eastern Cooperative Oncology Group (ECOG) performance status =1.
  • •11. Life expectancy =12 months as assessed by the investigator.
  • •12. Able to swallow the study treatment and have no known intolerance to study treatments or excipients.
  • •13. Sexually active participants that in the opinion of the investigator are capable of e

排除标准

  • •Patients with any of the following characteristics/conditions will be excluded:
  • •1. Any prior systemic cancer treatment initiated in the non-metastatic CRPC and mCRPC disease state. (ADT and first generation anti-androgens received in the CRPC disease state are NOT exclusionary.)
  • •2. Patients whose only evidence of metastasis is adenopathy below the aortic bifurcation.
  • •3. Prior treatment with second-generation androgen receptor inhibitors (enzalutamide, apalutamide, and darolutamide), a PARP inhibitor, cyclophosphamide, or mitoxantrone for prostate cancer.
  • •4. Prior treatment with platinum based chemotherapy within 6 months (from the last dose) prior to Day 1 (Part 1) or randomization (Part 2), or any history of disease progression on platinum based therapy within 6 months (from the last dose).
  • •Prior docetaxel for mCSPC is allowed if more than 4 weeks have elapsed from the last dose of docetaxel.
  • •5. Treatment with cytotoxic chemotherapy which includes but is not limited to docetaxel, biologic therapy including sipuleucel-T, or radionuclide therapy received in the castration-sensitive prostate cancer is NOT exclusionary if discontinued in the 28 days prior to Day 1 (Part 1) or randomization (Part 2). Prior treatment with abiraterone in the castration-sensitive settings is not exclusionary if discontinued prior to randomization. Hormonal therapy (eg, bicalutamide, nilutamide, flutamide, estrogens) are not exclusionary if discontinued prior to randomization. *Prednisone >10 mg/day (or equivalents) is exclusionary.
  • •6. Treatment with any investigational agent within before Day 1 (Part 1) or randomization (Part 2).
  • •7. Prior treatment with opioids for pain related to either primary prostate cancer or metastasis within 28 days prior to Day 1 (Part 1) or randomization
  • •8. Current use of potent P-gp inhibitors within 7 days prior to Day 1 (Part 1) or randomization (Part 2.) For a list of potent P-gp inhibitors, and other medications which are exclusionary because of interaction with either talazoparib or enzalutamide, refer to Section 5.9.
  • •9. Major surgery (as defined by the investigator) within 2 weeks before Day 1 (Part 1) or randomization (Part 2), or palliative localized radiation therapy within 3 weeks before randomization (Part 2)
  • •10. Clinically significant cardiovascular disease, including any of the following:
  • •- Myocardial infarction or symptomatic cardiac ischemia within 6 months before Day 1 (Part 1) or randomization (Part 2).
  • •- Congestive heart failure New York Heart Association class III or IV.
  • •- History of clinically significant ventricular arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation, torsade de pointes) within 1 year before screening.
  • •- History of Mobitz II second degree or third degree heart block unless a permanent pacemaker is in place.
  • •- Hypotension as indicated by systolic blood pressure <86 mm Hg at screening.
  • •- Bradycardia as indicated by a heart rate of <45 beats per minute on the screening electrocardiogram.
  • •- Uncontrolled hypertension as indicated by systolic blood pressure >170 mm Hg or diastolic blood pressure >105 mm Hg at screening. However, patients can be rescreened after adequate control of blood pressure is achieved.
  • •Please refer to protocol for the full list of exclusion criteria.

研究者

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