EUCTR2012-001067-79-BE进行中（未招募）1 期
A Clinical Study Of ColoAd1 Administered by Sub-Acute Fractionated Intravenous Injection: Dose Escalation in Metastatic Epithelial Solid Tumours and Randomised Controlled Trial in Metastatic Colorectal Cancer. - N/A
Psioxus Therapeutics Ltd.0 个研究点目标入组 173 人开始时间: 2012年7月3日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 173
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
- •INCLUSION CRITERIA FOR ALL PATIENTS
- •1. Patients must provide written informed consent
- •2. Age = 18 years and the patient must be at least the legal age limit to be able to give consent within the jurisdiction the study is taking place.
- •3. ECOG performance status 0 or 1
- •4. Predicted life expectancy of 3 months or more
- •5. Ability to comply with study procedures in the Investigator's opinion
- •6. Recovered to Grade 1 from the effects (excluding alopecia) of any prior therapy for their malignancies.
- •7. Adequate renal functions
- •a. Creatinine = 1.5 mg/dL or calculated creatinine clearance using the Cockcroft-Gault formula = 60 mL/min, or measured creatinine clearance =60 mL/min
- •b. Urine dipstick for proteinuria < 2+ or proteinuria 0.75g / 24 hours
- •8. Adequate hepatic function:
- •a. Serum bilirubin <1.5 mg/dL
- •b. Aspartate transaminase (AST) and alanine transaminase (ALT) = 3 x ULN
- •9. Adequate bone marrow function:
- •a. Absolute neutrophil count (ANC) = 1.5 x 109/L,
- •b. Platelets = 100 x 109/L
- •c. Haemoglobin = 100 g/L for UCC and = 90 g/L for other cancers
- •10. Adequate coagulation tests: INR = 1.5 x ULN;
- •11. For females of childbearing potential (defined as <2 years after last menstruation or not surgically sterile), a negative serum pregnancy test must be documented within 14 days prior to first administration of study treatment;
- •12. For women who are not postmenopausal (24 months of amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to use two adequate methods of contraception, during the treatment period
- •and for at least 3 months after the last dose of study drug.13. For men: agreement to use a barrier method of contraception during the treatment period and for at least 6 months after the last dose of study drug
- •14. At least 3 weeks since the last dose of any intravenous systemic chemotherapy and at least two weeks since the last oral dose of
- •capecitabine at time of first administration of ColoAd1.
- •For Phase 1 Dose Escalation Stage only (except Repeat Cycle Cohort):
- •15. Solid tumour of epithelial origin not responding to standard therapy or for whom no standard treatment exists
- •For Phase 1 Dose Expansion Stage Single Cycle and Dose Escalation Stage Repeat Cycle Cohort:
- •16. Metastatic colorectal carcinoma not responding to standard therapy,
- •17. = 3 prior lines of systemic therapy for advanced disease OR = 4 prior lines of systemic therapy for advanced disease if one of the 4 lines was an anti-EGFR therapy given as a single agent or combined to a previously administered chemotherapy regimen;
- •For Phase Ib:
- •18. mCRC not responding to standard therapy with no more than 3 prior lines of systemic therapy for advanced disease OR no more than 4 prior lines of systemic therapy for advanced disease if one of the 4 lines was an anti EGFR therapy given as a single agent or combined to a previously administered chemotherapy regimen
- •Advanced or metastatic UCC not a candidate for chemotherapy
- •For Phase 2:
- •19. Metastatic colorectal cancer;
- •20. Have received 3 - 4 months of first line chemotherapy with either FOLFOX, FOLFIRI or CAPOX, with or without bevacizumab;
- •21. At least one measurable lesion according to RECIST 1.1 criteria;
- •22. Documented partial response or stable disease;
- •23. Eligible to receive chemotherapy with FOLFOX or CAPOX after a short chemotherapy interruption (3-4 weeks)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 ye
排除标准
- •For all patients:
- •1. Pregnant or breast feeding females
- •2.Known history or evidence of significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or medication (e.g. systemic
- •corticosteroids, or other immunosuppressive medications including cyclosporine, azathioprine, interferons, within the past 4 weeks)
- •3. Splenectomy
- •4. Prior allogeneic or autologous bone marrow or organ transplantation
- •5. Active infections requiring antibiotics, physician monitoring, or recurrent fevers >38.0 degrees centigrade associated with a clinical
- •diagnosis of active infection
- •6. Active viral disease or known positive serology for HIV, hepatitis B or hepatitis C
- •7. Use of the following anti-viral agents: ribavirin, adefovir, lamivudine or cidofovir within 7 days prior to day 1; or PEG-IFN (within 14 days prior to first administration of ColoAd1)
- •8. Administration of an investigational drug within 28 days prior to first dose of ColoAd1
- •9. Major surgery within 4 weeks or radiotherapy within 3 weeks prior to first dose of ColoAd1
- •10. Another primary malignancy within the past 3 years (except for nonmelanoma skin cancer or cervical cancer in situ)
- •11. CNS metastasis that is symptomatic and/or requires treatment
- •12. Any condition or illness that, in the opinion of the Investigator or the medical monitor, would compromise patient safety or interfere with the evaluation of the safety of the drug
- •13. Known allergy to treatment medication or its excipients
- •14. Any other medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent.
- •For Phase 2 patients:
- •15. Progression on first line therapy
- •16. A complete response on first line therapy
- •17. Use of first line therapy for longer than 4 months
- •18. Use of any first line treatment with a chemotherapy regimen other than FOLFOX, FOLFIRI or CAPOX (with or without bevacizumab).
- •19. More than 6 weeks since the last administration of 5 FU, capecitabine, oxaliplatin or irinotecan.
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