EUCTR2020-000209-10-IT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
- 160
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
- •- Disease must be metastatic and inoperable and for which there is no curative intervention available. Participants may have bone-only disease.
- •- Participants presenting with treatment-emergent neuroendocrine differentiation, but not primary small-cell features, are eligible.
- •3 Known castrate-resistant disease, defined as:
- •- Testosterone level in the castration range (levels <50 ng/dl) because of a previous, and ongoing, androgen-deprivation with luteinizing hormone-releasing hormone (LHRH) agonists or antagonists or bilateral orchiectomy. Participants must have developed progression of metastases following surgical castration or during medical androgen ablation therapy. Participants receiving medical castration therapy with gonadotropin-releasing hormone (GnRH) analogues should continue this treatment during this study.
- •4 Evidence of disease progression =6 months defined by one or more of the following:
- •- Progression as defined by RECIST v1.1 criteria for assessment of malignant soft tissue disease and lymph nodes
- •- Progression of bone lesions on bone scan from a previous or baseline assessment per PCWG3
- •- Rising PSA
- •5 Must have measurable disease:
- •- At least 1 documented lesion on either a bone scan or a computed tomography (CT)/magnetic resonance imaging (MRI) scan that can be followed for response is suitable for repeated measurement
- •- Non-measurable disease must have measurable PSA > =1.0 ng/mL as the minimum starting level for trial entry if the confirmed rise is the only indication of progression (excluding small cell carcinoma)
- •6 Body weight >30 kg at screening.
- •7 Willingness to adhere to the study treatment-specific contraception requirements: Participants must be surgically sterile or using an acceptable method of contraception (defined as barrier methods in conjunction with spermicides) for the duration of the study (from the time they sign ICF) and for 3 months after the last dose of AZD4635 and/or durvalumab and/or cabazitaxel to prevent pregnancy in a female partner. Participants must not donate or bank sperm for 24 weeks after treatment.
- •8 Adequate bone marrow reserve and organ function as demonstrated by all of the following laboratory values:
- •- Absolute neutrophil count (ANC) >=1.5 × 10^9/L
- •- Platelet count >= 100 × 10^9/L
- •- Haemoglobin >= 9.0 g/dL
- •- Creatinine < =1.5 × ULN concurrent with creatinine clearance >50 mL/min (measured or calculated by Cockcroft and Gault equation); confirmation of creatinine clearance is only required when creatinine is >1.5 × ULN.
- •Additional Inclusion Criteria Specific for Arm A
- •9 Adequate organ function for Arm A as demonstrated by all of the following laboratory values:
- •- Alanine aminotransferase (ALT) < = 2.5 × the 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
- •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 32
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 128
排除标准
- •1 Active brain metastases or leptomeningeal metastases. Participants with brain metastases are eligible if treated and there is no evidence of progression for at least 8 weeks after treatment is completed and within 28 days prior to the first dose of study intervention.
- •2 There must be no requirement for immunosuppressive doses of systemic corticosteroids (>10 mg/day prednisone/equivalent) for at least 2 weeks prior to study enrollment.
- •3 Participant with a history of pneumonitis requiring corticosteroids.
- •4 History of a second malignancy that is progressing and/or received active treatment < = 3 years before the first dose of study intervention.
- •5 As judged by the Investigator, any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, or active infection including hepatitis B, hepatitis C, and human immunodeficiency virus. Screening for chronic conditions is not required.
- •6 Creatinine clearance <50 mL/min (calculated by Cockcroft-Gault equation).
- •7 Prior exposure to immune-mediated therapy including, but not limited to anti-CTLA-4, anti-PD-1, anti-PD-L1 and anti-PD-L2 antibodies, excluding therapeutic anti-cancer vaccines.
- •Additional Exclusion Criteria Specific for Arm B: Medical Conditions
- •8 Participant with active grade > = 2 peripheral neuropathy
- •9 Participant with active grade > = 2 stomatitis
- •10 Any small-molecule, biologic, or hormonal agent from a previous treatment regimen or clinical study within 21 days or 5 half-lives (whichever is shorter) prior to the first dose of study intervention. At least 7 days must have elapsed between the last dose of such agent and the first dose of study intervention. Exception: androgen-deprivation therapy is permitted.
- •11 History of hypersensitivity to polysorbate-80 if allocated to cabazitaxel.
- •12 Nitrosourea or mitomycin C within 6 weeks of the first dose of study intervention.
- •13 Prescription or non-prescription drugs or other products known to be sensitive BCRP or OAT1 substrates or to be strong inhibitors/inducers of CYP1A2, which cannot be discontinued 2 weeks prior to Day 1 of dosing and withheld throughout the study, until 2 weeks after the last dose of
- •study intervention.
- •14 Exclusion Criteria for Arm B: Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (CYP3A4/5) are excluded (a 2-week washout period is required for participants already on these treatments).
- •15 Herbal preparations/medications are not allowed throughout the study. These herbal medications include but are not limited to St. John's wort, kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone, yohimbe, saw palmetto, and ginseng.
- •Participants should stop using these herbal medications 7 days prior to the first dose of study intervention. Exceptions may be agreed, but the circumstances must be reviewed by the Medical Monitor/AZ Study Physician in advance.
- •16 Ongoing treatment with warfarin (Coumadin).
- •17 Receipt of live attenuated vaccine within 30 days prior to the first dose of study intervention.
- •18 Major surgery (excluding placement of vascular access) within 4 weeks of the first dose of study intervention.
- •19 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 intervention.
- •Please refer to the protocol for further details.
研究者
相似试验
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) - AARDVARCEUCTR2020-000209-10-FRAstraZeneca AB160
撤回
2 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).Progressive Metastatic Castrate-Resistant Prostate Cancer - Prostate cancer10027476NL-OMON51202Astra Zeneca10
进行中（未招募）
1 期
Study of the drug substances MLN0128 and MLN0128+MLN1117 Compared With Everolimus in the Treatment of Patients with metastatic clear cell renal carcinomametastatic clear-cell renal cell carcinoma (mccRCC)MedDRA version: 19.0 Level: PT Classification code 10050018 Term: Renal cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0 Level: LLT Classification code 10038407 Term: Renal cell cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2015-002133-22-ESMillenium Pharmaceuticals, a wholly owned subsidiary of Takeda pharmaceutical Company Limited189
进行中（未招募）
1 期
Study of the drug substances MLN0128 and MLN0128+MLN1117 Compared WithEverolimus in the Treatment of Patients with metastatic clear cell renal carcinomaEUCTR2015-002133-22-FRMillenium Pharmaceuticals, a wholly owned subsidiary of Takeda pharmaceutical Company Limited189
进行中（未招募）
1 期
International multicenter study to test the efficacy and safety of a new drug, KB195, in subjects with Urea Cycle Disorder with an inadequate control of the disease with current standard drugs.Subjects with a Urea Cycle Disorder with Inadequate Control on Standard of CareMedDRA version: 20.1Level: PTClassification code 10080020Term: Urea cycle disorderSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2018-004842-40-DEKaleido Biosciences29