ACTRN12614001292662终止1 期
Phase 1/2a Dose-Escalation Study of CRLX301 in Patients with Advanced Solid Tumor Malignancies
BlueLink Pharmaceuticals a subsidiary of NewLink Genetics0 个研究点目标入组 118 人开始时间: 2014年12月11日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 118
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Male or female adult patients older than or equal to 18 years of age
- •2. Diagnosis of histologically or cytologically confirmed, advanced solid tumour malignancy:
- •a) For Phase 1: that is refractory to standard therapy and/or for whom no further standard therapy is available, especially for those for whom taxane chemotherapy may be a reasonable therapeutic choice, in the opinion of the Investigator.
- •b) For Phase 2a: advanced/metastatic tumours considered responsive to taxanes
- •c) For prostate cancer patients in Phase 2a: that is castration resistant prostate cancer (CRPC*) and has not been previously treated with taxanes but has been treated with abiraterone and/or enzalutamide.
- •3. For patients enrolled in Phase 2a only: at least one measurable target lesion as defined by RECIST 1.1 criteria for solid tumours, except for patients with advanced prostate cancer (in which case as per the PCWG2 criteria). Tumours within a previously irradiated field should be designated as non-target” unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy.
- •4. If Patient has received:
- •a) approved chemotherapy or small molecule targeted therapy; it has been at least 2 weeks since last dose before CRLX301 first dose.
- •b) investigational therapy; it has been more than 30 days before first dose
- •c) local palliative radiation; it has been more than 14 days prior to first dose
- •d) radiation or invasive surgery requiring general anesthesia; it has been more than 30 days prior to first dose
- •e) chemotherapy with nitrosoureas or mitomycin C; it has been more than 45 days before first dose
- •5. ECOG Performance Status of 0 or 1
- •6. Life expectancy in opinion of Investigator of more than 12 weeks
- •7. Patients with acceptable pre-study hematology and biochemistry labs less than 72 hours prior to first dose
- •8. Fertile males or females of childbearing potential agree to use adequate contraception prior to study entry and for 30 days following last dose of study drug
- •9. Negative urine pregnancy test less than 72 hours prior to first dose (women of childbearing potential Only)
排除标准
- •1. Uncontrolled grade 2 or greater toxicity except alopecia related to any prior treatment (i.e. chemotherapy, targeted therapy, radiation or surgery) within 7 days prior to first dose unless approved by the Medical Monitor
- •2. Prolongation of QT/QTc interval
- •3. Women who are pregnant or nursing
- •4. Any known HIV infection or AIDS or any concurrent infection requiring IV antibiotics
- •5. Any chronic or concurrent acute liver disease, including viral hepatitis
- •6. Primary brain malignant tumors
- •7. Known metastases to the brain
- •8. Uncontrolled hypertension more than 150/100 mmHg
- •9. Concurrent participation in any other investigational study, unless non-interventional study and approved by Sponsor
- •10. Concurrent treatment with anticoagulation medication, except low molecular weight heparin, and approved by Sponsor
- •11. History of stroke, deep venous thrombosis (DVT), or transient ischemic attack (TIA), within 6 months prior to first dose
- •12. History of other cancer type, except for cutaneous basal cell or squamous cell carcinoma, or cervical in situ or very low/low risk prostate cancer, within the last 2 years prior to first dose.
- •13. Uncontrolled concurrent disease or illness including but not limited to:
- •a. symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia
- •b. unstable or untreated cardiac conditions or ejection fraction of less than 50% as determined by echocardiogram (ECHO) or multiple gated acquisition scan (MUGA)
- •c. diabetes mellitus
- •d. coagulation disorder
- •e. psychiatric illness that would limit compliance with study requirements, as determined by the Investigator
- •14. History of severe hypersensitivity reaction to taxanes.
- •15. For Phase 2a Stage 2: treatment with a taxane within 6 months of first dose; advanced prostate cancer patients must be taxane-naive
- •16. Peripheral neuropathy
- •17. Other severe, acute, or chronic medical or psychiatric condition or laboratory
- •abnormality that may increase the risk associated with study participation or study
- •drug administration or that may interfere with the interpretation of study results and,
- •in the judgment of the investigator, would make the patient inappropriate for the
研究者
相似试验
终止
1 期
Phase 1/2a Dose-Escalation Study of CRLX301 in Patients With Advanced Solid TumorsAdvanced Solid Tumor MalignancyNCT02380677NewLink Genetics Corporation42
进行中（未招募）
1 期
Study of CHR-3996 in combination with tosedostat in subjects with multiple myelomaEUCTR2011-001914-33-GBniversity of Leeds27
已完成
1 期
Study of CHR-3996 in combination with tosedostat in subjects with multiple myelomaMultiple myelomaCancerISRCTN24989786niversity of Leeds (UK)60
未知
1 期
Phase 1 Dose-Escalation Study of LY2157299 Monotherapy in Patients With Solid TumorsSolid TumorJPRN-jRCT2080221965Eli Lilly Japan K.K.
已完成
1 期
CRLX101 Plus Bevacizumab in Advanced RCCRenal Cell CarcinomaNCT01625936Abramson Cancer Center at Penn Medicine22