EUCTR2011-004126-10-ES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/microL)
- •Hemoglobin >= 9 g/dL
- •Platelet count >= 100,000/microL
- •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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