EUCTR2011-004126-10-FR进行中（未招募）1 期
A PHASE Ib/II STUDY OF GDC-0068 OR GDC-0980 WITH ABIRATERONE ACETATE VERSUS ABIRATERONE ACETATE IN PATIENTS WITH CASTRATION-RESISTANT PROSTATE CANCER PREVIOUSLY TREATED WITH DOCETAXEL-BASED CHEMOTHERAPY
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 258
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
- •Patients must meet all the following criteria to be eligible for study entry:
- •Signed Informed Consent Form(s)
- •Histologically or cytologically confirmed metastatic or advanced prostate
- •adenocarcinoma that has been previously treated with docetaxel and has progressed during treatment of at least one hormonal therapy (luteinizing hormone-releasing hormone, bicalutamide, etc.)
- •Availability at the site of a representative formalin-fixed, paraffin-embedded
- •tumor specimen that enabled the definitive diagnosis of prostate cancer, accompanied by an associated pathology report (required prior to randomization)
- •The specimen must contain adequate viable tumor cells (= 20% for excisional
- •biopsy and = 50% if sample is a core biopsy).
- •Specimen may consist of a tissue block (preferred) or 15-20 unstained, serial
- •slides. Cytologic or fine-needle aspiration samples are not acceptable.
- •If archival tissue is either insufficient or unavailable, the patient may still be
- •eligible, upon discussion with the Medical Monitor, assuming the patient
- •Can provide = 5 unstained, serial slides
- •Is willing to consent to and undergo a pretreatment core or excisional biopsy of the tumor. Cytologic or fine-needle aspiration samples are
- •not acceptable.
- •Two rising PSA levels = 2 ng/mL measured = 1 week apart that meet the
- •PCWG2 criteria for progression prior to initiation of study treatment or
- •radiographic evidence of disease progression in soft tissue or bone, with or
- •without disease progression on the basis of the PSA value
- •Ongoing androgen deprivation, with serum testosterone < 50 ng/dL (< 2.0 nM/L)
- •ECOG performance status of 0, 1, or 2 at screening
- •Adequate hematologic and organ function within 14 days before the first study treatment, defined by the following (hematologic parameters must be
- •assessed = 14 days after a prior transfusion, if any):
- •Neutrophils (ANC = 1500/µL)
- •Hemoglobin = 9 g/dL
- •Platelet count = 100,000/µL
- •Total bilirubin = 1.5 × ULN with the following exception:
- •Patients with known Gilbert’s disease who have serum bilirubin = 3 × ULN may be enrolled.
- •AST and ALT = 2.5 × ULN, with the following exceptions:
- •Patients with documented liver metastases may have AST and/or
- •ALT = 5 × ULN.
- •Serum albumin = 3 g/dL
- •Serum creatinine = 1.5 × ULN or creatinine clearance of > 50 mL/min
- •based on a 24-hour urine collection
- •Fasting total serum glucose = 150 mg/dL
- •Documented willingness to use an effective means of contraception
- •(e.g., abstinence, hormonal or double barrier method, surgically sterilized partner) while participating in the study
- •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 65
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 193
排除标准
- •Patients who meet any of the following criteria will be excluded from study entry:
- •Small cell or neuroendocrine prostate carcinoma
- •History of Type I or Type II diabetes mellitus requiring insulin Patients who are on a stable dose of oral diabetes medication = 4 weeks prior to initiation of study treatment may be eligible for enrollment.
- •Inability or unwillingness to swallow pills
- •Malabsorption syndrome or other condition that would interfere with
- •enteral absorption
- •Congenital long QT syndrome or QTc > 500 msec
- •NYHA Class III or IV heart failure or LVEF < 50% or ventricular arrhythmia
- •requiring medication
- •Any requirement for supplemental oxygen therapy to perform activities of daily living
- •Current unstable angina or history of myocardial infarction within 6 months
- •prior to Day 1
- •Active infection requiring IV antibiotics
- •Active autoimmune disease that is not controlled by nonsteroidal
- •anti-inflammatory drugs or active inflammatory disease, including small or
- •large intestine inflammation such as Crohn’s disease or ulcerative colitis,
- •which requires immunosuppressive therapy
- •Clinically significant history of liver disease consistent with Child-Pugh Class B or C, including viral or other hepatitis, current alcohol abuse, or cirrhosis
- •History of adrenal insufficiency or hyperaldosteronism
- •Known HIV infection
- •Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patients at high risk from treatment complications
- •Significant traumatic injury within 4 weeks prior to initiation of study treatment
- •(all wounds must be fully healed)
- •Major surgical procedure within 4 weeks prior to initiation of study treatment
- •Treatment with chemotherapy, hormonal therapy (except GnRH agonists or antagonists for prostate cancer), immunotherapy, biologic therapy, radiation therapy (except palliative radiation to bony metastases), or herbal therapy as
- •cancer therapy within 2 weeks prior to initiation of study treatment
- •Previous therapy for prostate cancer with CYP17 inhibitors, including abiraterone and ketoconazole, or previous treatment with MDV3100
- •Previous treatment for prostate cancer with Akt, PI3K, and/or mTOR inhibitors
- •Need for chronic corticosteroid therapy of = 20 mg of prednisone per day or an equivalent dose of other anti inflammatory corticosteroids or immunosuppressant
- •Treatment with an investigational agent within 4 weeks prior to initiation of study treatment
- •Malignancies other than prostate cancer within 5 years prior to initiation of study treatment, except for adequately treated basal or squamous cell skin
- •cancer and non-muscle-invasive bladder cancer
- •Unresolved, clinically significant toxicity from prior therapy, except for alopecia and Grade 1 peripheral neuropathy
- •Inability to comply with study and follow-up procedures
研究者
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