EUCTR2020-000209-10-NL进行中（未招募）1 期
A Phase II, Open-label Study to Assess the Efficacy, Safety, and Tolerability of AZD4635 in Combination with Durvalumab and in Combination with Cabazitaxel and Durvalumab in Patients Who Have Progressive Metastatic Castrate-Resistant Prostate Cancer (AARDVARC) - AARDVARC
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
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
- •1 Participant must be 18 years of age inclusive at the time of signing the informed consent.
- •2 Histologically confirmed adenocarcinoma of the prostate.
- •3 Known castrate-resistant disease.
- •4 Evidence of disease progression =6 months.
- •5 Body weight >30 kg at screening.
- •6 Willingness to adhere to the study treatment-specific contraception requirements.
- •7 Adequate bone marrow reserve and organ function.
- •8 Adequate organ function for Arm A as demonstrated by all of the following laboratory values:
- •- Alanine aminotransferase (ALT) =2.5 × upper limit of normal (ULN) if no demonstrable liver metastases or =5 × ULN in the presence of liver metastases.
- •- Aspartate aminotransferase (AST) =2.5 × ULN if no demonstrable liver metastases or =5 × ULN in the presence of liver metastases
- •- Total bilirubin (TBL) =1.5 × ULN - TBL =2.0 × ULN in the case of known Gilbert syndrome with normal direct bilirubin
- •9 Participants in Arm A must have received the following prior therapy:
- •- Maximum of 3 lines of therapy in the mCRPC setting
- •- Prior therapy with one or more NHAs (eg, abiraterone acetate, enzalutamide, apalutamide, darolutamide) in either hormone-sensitive or hormone-refractory settings
- •- Prior therapy with one or more lines of taxanes (eg, docetaxel and/or cabazitaxel)
- •- Alternatively, must be taxane-ineligible
- •- Prior therapy can be in either the hormone-sensitive or the hormone-refractory setting
- •10 Adequate organ function for Arm B as demonstrated by all of the following laboratory values:
- •- AST and/or ALT =1.5 × ULN
- •- TBL = ULN - TBL =2.0 × ULN in the case of known Gilbert syndrome with normal direct bilirubin
- •11 Participants in Arm B must have received the following prior therapy:
- •- Prior docetaxel (taxane) in either hormone-sensitive or hormone-refractory settings
- •- Received no prior cytotoxic chemotherapy other than docetaxel for prostate cancer except for estramustine and except adjuvant/neo-adjuvant treatment completed >3 years ago.
- •- Prior therapy with only one NHAs (eg, abiraterone acetate or enzalutamide; prior apalutamide is not permitted) for treatment of mCRPC in either hormone-sensitive or hormone-refractory settings.
- •- Be suitable to receive concomitant Granulocyte-colony stimulating factor during all cycles of cabazitaxel.
- •- Participants who meet inclusion criteria for Arm B will be allocated preferentially to that arm until recruitment to that arm is completed.
- •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 16
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 64
排除标准
- •1 Active brain metastases or leptomeningeal metastases.
- •2 There must be no requirement for immunosuppressive doses of systemic corticosteroids for at least 2 weeks prior to study enrollment.
- •3 History of pneumonitis, second malignancy that is progressing and/or received active treatment =3 years before the first dose of study intervention, and hypersensitivity to polysorbate-80 if allocated to cabazitaxel.
- •4 As judged by the Investigator, any evidence of severe or uncontrolled systemic diseases.
- •5 Creatinine clearance <40 mL/min (calculated by Cockcroft-Gault equation).
- •6 Prior exposure to immune-mediated therapy.
- •7 History of allogeneic organ transplantation.-
- •8 Active or prior documented autoimmune or inflammatory disorders
- •9 History of active primary immunodeficiency.
- •10 Active infection including tuberculosis
- •11 Receipt of live attenuated vaccine within 30 days prior to the first dose of study intervention.
- •12 Ongoing treatment with warfarin (Coumadin).
- •13 Major surgery (excluding placement of vascular access) within 4 weeks of the first dose of study intervention.
研究者
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