EUCTR2010-022239-12-HU进行中（未招募）不适用
A Phase 1b/2 Study of Docetaxel and Prednisone, with or without ISIS 183750 (an eIF4E Inhibitor), inPatients with Castrate-Resistant Prostate Cancer - N/A
Isis Pharmaceuticals, Inc.0 个研究点目标入组 112 人开始时间: 2011年5月31日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 112
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 with castrate-resistant prostate cancer are eligible to be included in the study only if they meet all of the
- •following criteria:
- •1. Provide written informed consent prior to Screening.
- •2. Age = 18 years.
- •3. Histological or cytological diagnosis of adenocarcinoma of the prostate.
- •4. Metastatic disease for which no curative therapy exists and for which systemic
- •chemotherapy is indicated.
- •5. Progression of disease despite either medical or surgical castration. If the patient
- •received medical androgen ablation, a castrate level of testosterone (= 50 ng/dL)
- •must have been present concurrent with disease progression. Progressive disease is
- •defined as any one of the following:
- •Rising serum PSA levels: two consecutive increases in PSA levels documented
- •over a previous reference value obtained at least one week apart with the value of
- •the third point being = 2 ng/mL. If the third PSA level is less than the second, an
- •additional fourth test to confirm a rising PSA (i.e., the fourth value is = the second
- •value and is = 2 ng/mL) is acceptable.
- •Progressive measurable disease defined as an increase in the sum of the diameters of measurable lesions over
- •the smallest sum observed or the appearance of one or more new lesions as assessed by CT scan.
- •Bone progressions: appearance of 2 or more new lesions on bone scan or other
- •6. If patient did not have a surgical orchiectomy:
- •The patient must be on androgen suppression treatment (e.g. LHRH agonist), have
- •a castrate level of testosterone (= 50 ng/dL), and must be willing to continue the
- •treatment throughout the study.
- •The patient must have discontinued treatment with anti-androgens (discontinued
- •= 4 weeks for flutamide and = 6 weeks for nilutamide or bicalutamide prior to
- •Screening) and have documented disease progression following discontinuation.
- •7. PSA = 2 ng/mL during the Screening period.
- •8. Performance status of 0 or 1 on the ECOG Performance Status Scale.
- •9. Have an estimated life expectancy of at least 12 weeks.
- •10. Adequate organ function within 14 days prior to first study dose (ISIS 183750 or
- •docetaxel, whichever occurs first) including the following:
- •a. Absolute neutrophil count (ANC) = 1.5 x 10(9)/L.
- •b. Platelet count = 100 x 10(9)/L.
- •c. Total bilirubin = 1.0 x upper limit of normal (ULN).
- •d. Aspartate aminotransferase (AST) = 1.5 x ULN.
- •e. Alanine aminotransferase (ALT) = 1.5 x ULN.
- •f. Serum creatinine = 1.5 x ULN.
- •g. Prothrombin time (PT) and international normalized ratio (INR) within normal limits.
- •h. Activated partial thromboplastin time (aPTT) within normal limits.
- •11. Part 1: Have had no more than 1 prior chemotherapy or biological therapy regimen (approved or
- •experimental; all previous hormonal therapies are allowed and not counted as biological therapy for this
- •inclusion criterion) for prostate cancer. This does not include treatments that may have been received in the
- •adjuvant or
- •neoadjuvant setting. A regimen is defined as two or more consecutive cycles of
- •Part 2: Have had no prior chemotherapy or biological therapy (approved or
- •experimental; all previous hormonal therapies are allowed and not counted as
- •biological therapy for this inclusion criterion) in any setting for prostate cancer.
- •12. Have discontinued all previous therapies for cancer (except treatment with LHRH
- •analogues) as follows:
- •a. Part 1: cytotoxic chemotherapy must be discontinued at least 4 weeks prior to
- 另有 2 项未显示
排除标准
- •Patients will be excluded from the study if they meet any of the following criteria:
- •1. Treatment with another investigational drug or device within 4 weeks or biological
- •agent within 6 weeks before Screening or 5 half-lives of study agent, whichever is
- •2. Pre-existing peripheral neuropathy = Common Terminology Criteria for Adverse
- •Events, Version 4.0 (CTCAE) Grade 2.
- •3. Patients with treated or untreated parenchymal brain metastases or leptomeningeal disease. Currently active
- •malignant epidural disease is also excluded. Previously treated epidural disease does not exclude the patient from
- •the study. (Note: CT or MRI of brain is not needed to rule these out unless the patient has clinical symptoms
- •suggestive of CNS metastases).
- •4. Have active infection or serious concomitant systemic disorder (for example, heart
- •failure) incompatible with the study (at the discretion of the Investigator).
- •5. Presence or history of other malignancies except non-melanoma skin cancer or solid tumors curatively treated
- •at least 5 years previously with no subsequent evidence of recurrence.
- •6. Presence of an underlying disease state associated with active bleeding.
- •7. Ongoing therapy with oral or parenteral anticoagulants (e.g., heparin, warfarin/coumadin). Low-dose
- •anticoagulants for maintenance of catheter patency
- •and low dose aspirin (= 325 mg/day) and nonsteroidal antiinflammatory agents are
- •not exclusionary.
- •8. Concurrent treatment with other anticancer drugs.
- •9. Inability to comply with protocol or study procedures.
- •10. Previous therapy with strontium or samarium.
- •11. Patients who have had irradiation of = 25% of the bone marrow (e.g. pelvic
- •irradiation).
- •12. Use of any herbal products, including saw palmetto within 1 week of screening and throughout the study.
- •13. Initiation of treatment with bisphosphonates, or change in dose, within 4 weeks of assignment to dosing in
- •this study. Patients taking bisphosphonates should not have their dosing regimen altered during the study unless
- •medically warranted.
- •14. Known history of HIV, HCV, or chronic HBV infection.
- •15. Previous treatment with a therapeutic antisense oligonucleotide or siRNA.
- •16. Planned concomitant participation in another clinical trial of an experimental agent, vaccine, or device.
- •17. Have any other medical conditions that, in the opinion of the Investigator, would
- •make the patient unsuitable for enrollment, or could interfere with the patient
- •participating in or completing the study.
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