EUCTR2012-000871-17-CZ进行中（未招募）1 期
An International Phase 3 Randomized Trial of Autologous Dendritic Cell Immunotherapy (AGS-003) Plus Standard Treatment of Advanced Renal Cell Carcinoma (ADAPT) - ADAPT
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 450
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
- All
入选标准
- •1. Age = 18 years
- •2. Advanced disease, histologically assessed as RCC, with a component
- •of predominatly clear cell histology
- •3. Metastatic disease (measureable or non-measurable) that can be
- •monitored throughout the course of the study participation per RECIST
- •4. Subjects who are candidates for a standard first-line therapy initiating
- •with sunitinib
- •5. Time from initial RCC diagnosis to initiation of systemic treatment
- •(sunitinib) of <1 year
- •6. Karnofsky Performance Status (KPS) = 70%
- •7. Life expectancy of 6 months or greater
- •8. Resolution of all acute toxic effects of prior radiotherapy or surgical
- •procedures to Grade = 1 according to National Cancer Institute (NCI)
- •Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
- •9. Adequate hematologic function, as defined by central laboratory
- •XML File Identifier: oY4zEZu1kCwIyYhbPwByJbSkN9Y=
- •values for all three of the following criteria (per the central lab):
- •a. Absolute neutrophil count (ANC) = LLN, and
- •b. Platelets = 75,000/mm3 or 75.0 x 109/L, , and
- •c. Hemoglobin (Hgb) = 8.0 g/dL
- •10. Adequate renal and hepatic function, as defined by either of the
- •following criteria:
- •a. Serum creatinine = 1.5 x upper limit of normal (ULN)
- •b. OR, if serum creatinine > 1.5 x ULN, estimated glomerular filtration
- •rate (eGFR) = 30 mL/min
- •11. Adequate hepatic function, as defined by both of the following:
- •a. Total serum bilirubin = 1.5 x ULN
- •b. Aspartate aminotransferase (AST) and alanine aminotransferase
- •(ALT) = 2.5 x ULN
- •- or, AST and ALT = 5 x ULN if liver function abnormalities are due to
- •underlying malignancy
- •12. Adequate coagulation function as defined by either of the following
- •a. Corrected calcium = 11.5 mg/dL
- •b. Activated partial thromboplastin time (PTT) < 1.5 x ULN
- •a. INR <1.5 x ULN
- •b.For subjects receiving warfarin or LMWH, the subjets must, in the
- •investigator's opinion, be clinically stable with no evidence of active
- •bleeding while receiveing anticoagulant therapy. The INR for these
- •patietns may exceed 1.5 x ULN if that is the goal of anticoagulant
- •13. Negative serum pregnancy test for female subjects with reproductive
- •potential, and agreement of all male and female subjects of reproductive
- •potential to use a reliable form of contraception during the study and for
- •12 weeks after the last dose of study drug
- •14. Normal ECG or clinically non-significant finding(s) at Screening, in
- •the Investigator's opinion
- •15. Able to abstain from taking prohibited drugs, either prescription or
- •non-prescription, during the treatment phase of the study
- •16. Willingness and ability to comply with scheduled visits, treatment
- •plans, laboratory tests, and other study procedures
- •17. Signed and dated informed consent document indicating that the
- 另有 8 项未显示
排除标准
- •1. Prior systemic therapy (including adjuvant or neoadjuvant) of any kind for RCC, including immunotherapy, chemotherapy, hormonal, or investigational therapy
- •2. Prior history of malignancy other within the preceding 3 years, except for adequately treated in situ carcinomas or non-melanoma
- •skin cancer, adequately treated early stage breast cancer,
- •superficial bladder, and non-metastatic prostate cancer with a normal
- •3. History of or known brain metastases, spinal cord compression, or carcinomatous meningitis, or evidence of brain or leptomeningeal disease
- •4. Patients will be excluded if they have 5 or more of the following risk factors at Screening:
- •a. Hgb < LLN
- •b. Corrected calcium > 10.0 mg/dL
- •c. KPS < 80%
- •d. Neutrophils > ULN
- •e. Platelets > ULN
- •5. NCI CTCAE Grade 3 hemorrhage < 28 days before Visit 1 (Day 0)
- •6. Clinically significant cardiovascular conditions within 3 months prior
- •to Randomization, which in the Investigator's opinion prohibits the
- •initiation of standard targeted therapy, initiating with sunitinib,
- •a. Cardiac angioplasty
- •b. Myocardial infarction
- •c. Unstable angina
- •d. Coronary artery by-pass graft or stenting
- •e. Class III or IV congestive heart failure (CHF), per NYHA Classification
- •f. Symptomatic peripheral vascular disease
- •g. Cerebrovascular accident (CVA) or transient ischemic attack (TIA)
- •h. Pulmonary Sumptomatic or uncontrolled pulmonary embolism or deep
- •vein thrombosis (DVT)
- •i. Uncontrolled cardiac dysrhythmias of NCI CTCAE Grade = 2, atrial
- •fibrillation of any grade, or prolongation of the QTc for males > 450 msec
- •and for females > 470 msec as corrected by either the Fridericia or
- •Bazett formula
- •j. Uncontrolled or untreated atrial fibrillation
- •k. Poorly controlled hypertension, defined as a systolic blood pressure
- •(SBP) = 150 mm Hg or diastolic blood pressure (DBP) = 90 mm Hg
- •- NOTE: Initiation of antihypertensive medication(s) is permitted prior
- •to study entry. Blood pressure must be re-assessed on 2 occasions
- •separated by at least 1 hour. The mean SBP/DBP values must be <
- •150/90 mm HGfor a subject to be eligible.
- •l. Ongoing treatment with therapeutic doses of warfarin (oral low-dose
- •warfarin up to 2 mg daily for DVT prophylaxis is allowed)
- •l. Evidence of active bleeding or a bleeding diathesis at Screening
- •7. Significant gastrointestinal abnormalities:
- •a. Any history of major resection of the stomach or small bowel with
- •ongoing impaired healing, which would significantly impair the
- •absorption of sunitinib or other permitted oral targeted therapies during
- •study treatment, in the Investigator's opinion.
- •b. Malabsorption syndrome with active symptoms, which would
- •significantly impair the aborption of sunitinib or other permitted oral
- •targeted therapies in the Investigator's opinion, within 3 months prior to
- •Randomization.
- •c. Active peptic ulcer, which cannot be appropriately managed in the
- •Investigator's opinion, within 3 months prior to Randomization
- •d. Intra-luminal bleeding lesions within 3 months prior to Randomization
- 另有 7 项未显示
研究者
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