JPRN-jRCT2031210609招募中1 期
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
Hibi Kazushige0 个研究点目标入组 804 人开始时间: 2022年2月15日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 804
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
- >= 18age old 至 ot applicable（—）
- 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 and moderate 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
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