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临床试验/jRCT2031210609
jRCT2031210609招募中不适用

This research is designed to determine if experimental treatment with PARP inhibitor, AZD5305, alone, or in combination with anti-cancer agents is safe, tolerable, and has anti-cancer activity in patients with advanced solid tumors (PETRA)

Astrazeneca K.K0 个研究点目标入组 804 人开始时间: 待定最近更新:
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试验速览

阶段
不适用
状态
招募中
入组人数
804
研究概览研究设计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
分配方式
Single Arm Study
干预模型
Single Assignment
主要目的
Treatment Purpose
盲法
Open(masking Not Used)

入排标准

年龄范围
18age old over 至 No limit（—）
性别
All

入选标准

  • •Age 18 or more at the time of screening
  • •Histological or cytological confirmation of advanced malignancy considered to be suitable for study treatment and meeting module specific eligibility criteria
  • •Eastern Cooperative Oncology Group Performance status (ECOG PS: 0-2)
  • •Life expectancy 12 weeks or more
  • •Progressive cancer at the time of study entry
  • •Patients must have evaluable disease as defined in module-specific criteria for Part A and Part B
  • •Adequate organ and marrow function as defined by the protocol.
  • •For Part B expansion cohorts: Provision of formalin-fixed and paraffin embedded (FFPE) tumour specimen is mandatory, where available, except if stated that it is optional in a specific Module.
  • •For Part A:
  • •Patients may have received up to one prior line of therapy with a PARPi-based regimen (either as a treatment or as maintenance)
  • •For Part B:
  • •Patients must not have received prior therapy with a PARPi-based regimen (either as a treatment or as maintenance).

排除标准

  • •Treatment with any of the following:
  • •1.Nitrosourea or mitomycin C within 6 weeks of the first dose of study treatment
  • •2.Any investigational agents or study drugs from a previous clinical study within 5 half-lives or 3 weeks (whichever is shorter) of the first dose of study treatment
  • •3.Any other chemotherapy, immunotherapy or anticancer agents within 3 weeks of the first dose of study treatment
  • •4.Any live virus or bacterial vaccine within 28 days of the first dose of study treatment
  • •Concomitant use of medications or herbal supplements known to be cytochrome P450 3A4 (CYP3A4) strong inhibitors or inducers.
  • •Concomitant use of drugs that are known to prolong or shorten QT and have a known risk of Torsades de Pointes.
  • •Receiving continuous corticosteroids at a dose of >10 mg prednisone/day or equivalent for any reason.
  • •Major surgery within 4 weeks of the first dose of study treatment.
  • •Radiotherapy with a wide field of radiation within 4 weeks or radiotherapy with a limited field of radiation for palliation within 2 weeks of the first dose of study treatment.
  • •Any history of persisting (> 2 weeks) severe pancytopenia due to any cause
  • •Spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring continuous corticosteroids at a dose of over 10mg prednisone/day or equivalent for at least 4 weeks prior to start of study treatment. Patients with leptomeningeal carcinomatosis are excluded.
  • •patient with known predisposition to bleeding (e.g., active peptic ulceration, recent [within 6 months] haemorrhagic stroke, proliferative diabetic retinopathy).
  • •Cardiac conditions as defined by the clinical study protocol
  • •Other cardiovascular diseases as defined by the clinical study protocol
  • •Patients with myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of myelodysplastic syndrome (MDS)/acute myeloid leukaemia (AML).
  • •Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of AZD5305
  • •Known allergy or hypersensitivity to investigational product(s) or any of the excipients of the investigational product(s).
  • •Prior malignancy whose natural history, in the Investigator's opinion, has the potential to interfere with safety and efficacy assessments of the investigational regimen.
  • •other module-specific criteria may apply

研究者

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