NL-OMON51202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). - AARDVARC
Astra Zeneca0 个研究点目标入组 10 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 入组人数
- 10
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
- 18 至 99（—）
入选标准
- •Inclusion Criteria
- •1 Participant must be 18 years of age inclusive at the time of signing the
- •informed consent.
- •Type of Participant and Disease Characteristics
- •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
- •* 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 defined as at least two consecutive rises in PSA to be documented
- •over a reference value (measure 1) taken at least 1 week apart. The first
- •rising PSA (measure 2) should be taken at least 7 days after the reference
- •value. A third confirmatory PSA measure is required (2nd and beyond the
- •reference level) to be greater than the second measure and it must be obtained
- •at least 7 days after the 2nd measure. If this is not the case, a fourth PSA
- •measure is required to be taken and be greater than 2nd measure. The third (or
- •the fourth) confirmatory PSA should be taken within 4 weeks prior to study
- •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.
- •Reproduction
- •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 a male condom in conjunction with
- •spermicides) for the duration of the study (from the time they sign ICF) and
- •for 12 weeks (3 months) after the last dose of AZD4635 and/or durvalumab and
- •for 24 weeks (6 months) after the last dose of cabazitaxel to prevent pregnancy
- •in a female partner. Participants must not donate or bank sperm for 24 weeks
- •after treatment. The reporting of any pregnancy in the female partner of a
- •participant is described in Section 8.3.9.1 of the protocol.
- •Bone Marrow Reserve and Organ Function
- •8 Adequate bone marrow reserve and organ function as demonstrated by all of the
- 另有 2 项未显示
排除标准
- •Exclusion Criteria
- •Participants are excluded from the study if any of the following criteria apply:
- •Medical Conditions
- •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. For current or prior use of immunosuppressive medication
- •within 14 days before the first dose the following will be exceptions to this:
- •* Intranasal, inhaled, topical steroids, or local steroid injections (e.g.,
- •intra-articular injection)
- •* Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of
- •prednisone or its equivalent
- •* Steroids as premedication for hypersensitivity reactions (e.g., CT scan
- •premedication)
- •3 Participant with a history of pneumonitis.
- •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, active infection including hepatitis B, hepatitis C, and human
- •immunodeficiency virus, chronic gastrointestinal diseases (e.g., Crohn's
- •disease, chronic colitis), ongoing or active infection, symptomatic congestive
- •heart failure, uncontrolled hypertension, unstable angina pectoris,
- •uncontrolled cardiac arrhythmia, or active interstitial lung disease (ILD).
- •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.
- •8 History of allogeneic organ transplantation.
- •9 Active or prior documented autoimmune or inflammatory disorders (including
- •inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis
- •[with the exception of diverticulosis], systemic lupus erythematosus,
- •Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis,
- •Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The
- •following are exceptions to this criterion:
- •* Participants with vitiligo or alopecia
- •* Participants with hypothyroidism (e.g., following Hashimoto syndrome) stable
- •on hormone replacement
- •* Any chronic skin condition that does not require systemic therapy
- •* Participants without active disease in the last 5 years may be included but
- •only after consultation with the Study Physician
- •* Participants with coeliac disease controlled by diet alone
- •10 History of active primary immunodeficiency.
- •11 Active infection including tuberculosis (clinical evaluation that may
- •include clinical history, physical examination and radiographic findings, and
- •tuberculosis testing in line with local practice).
- 另有 4 项未显示
研究者
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