ISRCTN96787846已完成不适用
A phase I study of the safety, tolerability, and antitumor activity of escalating doses of combretastatin A4 phosphate given in combination with bevacizumab to subjects with advanced solid tumors
OXiGENE, Inc. (USA)0 个研究点目标入组 12 人开始时间: 2006年12月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Histopathologically or cytologically confirmed malignant solid tumours that have failed standard therapy or for which no life prolonging treatment exists
- •2. Measurable disease as defined by the Response Evaluation Criteria In Solid Tumours (RECIST) criteria
- •3. At least four weeks since any prior immunotherapy, chemotherapy or radiation therapy prior to first dose of study drug (six weeks for therapy known to be associated with delayed toxicity such as nitrosoureas or mitomycin-C)
- •4. Age more than or equal to 18 years old
- •5. Adequate bone marrow function:
- •a. Absolute granulocyte count (neutrophils and bands) more than 1500 cells/mm^3
- •b. Platelet count more than 100,000 cells/mm^3
- •c. Haemoglobin more than 9 g/dL
- •6. Adequate renal function (Glomerular Filtration calculated by Cockcroft/Gault formula or measure urine creatinine clearance more than 50 mL/minute)
- •7. Adequate hepatic function:
- •a. Bilirubin less than 1.5 mg/dL
- •b. Aspartate Transaminase (AST) and Alanine Transaminase (ALT) less than 2.5 times the institutional Upper Limit of Normal (ULN) (or less than five times ULN if liver metastases are present)
- •8. Eastern Cooperative Oncology Group (ECOG) performance status zero to two
- •9. Life expectancy of more than or equal to 12 weeks
- •10. Written, signed, dated, and witnessed (if applicable as per International Conference on Harmonisation [ICH] guidelines) Independent Ethics Committee (IEC) approved informed consent form before any study specific screening procedures are performed
- •11. Fertile subjects must abstain from sexual intercourse or use effective birth control
- •12. All Women Of Child-Bearing Potential (WOCBP) must have a negative serum pregnancy test within 72 hours of first dose
排除标准
- •1. Contraindications, allergies or sensitivity to the use of the study medications or any other products required for participation in this study (i.e. contrast agents)
- •2. Presence of Central Nervous System (CNS) metastases
- •3. Diagnosed Squamous Non-Small Cell Lung Cancer (NSCLC)
- •4. History of Gastrointestinal Perforations
- •5. Surgery within 28 days of screening visit or a surgical incision that is not fully healed. Any surgery planned during the study period
- •6. Proteinuria more than 1 g/24 hours by 24 hour urine collection (perform 24 hour urine collection if more than 1+ on dipstick)
- •7. Recent haemoptysis (occurrence within the past three months)
- •8. Prior therapy with CA4P or bevacizumab, or other agents which target Vascular Endothelial Growth Factor (VEGF) or Vascular Endothelial Growth Factor Receptor (VEGFR) signalling such as Sorafenib and Sutent
- •9. Prior radiation involving more than 30% of the bone marrow
- •10. Radical radiotherapy to the thorax or abdomen at any time or post-operative radical radiotherapy to the pelvis. Palliative radiotherapy treatments are acceptable. Subjects with rectal primaries who have received pre-operative pelvic radiotherapy or chemoradiation are eligible if the small bowel was mobile and not stuck to the tumour
- •11. Active autoimmune disorder(s)
- •12. Immuno-compromised, including subjects known to be Human Immunodeficiency Virus (HIV) positive
- •13. Active infection requiring antibiotic therapy or any other serious intercurrent illness
- •14. History of angina (stable or severe, even if controlled with medications), myocardial infarction, Congestive Heart Failure (CHF), non-controlled atrial arrhythmias or clinically significant arrhythmias including conduction abnormality, nodal junctional arrhythmias and dysrhythmias, sinus bradycardia or tachycardia, supraventricular arrhythmias, atrial fibrillation or flutter, syncope or vasovagal episodes
- •15. Electrocardiogram (ECG) with evidence of prior myocardial infarction (e.g., significant Q waves), QTc more than 450 msec or other clinically significant abnormalities
- •16. Taking any drug(s) known to prolong the QTc interval, which cannot be interrupted for at least four days during each treatment cycle
- •17. Known significant heart wall abnormality or heart muscle damage as evidenced on Multiple Gated Acquisition (MUGA) scan or echocardiogram (this is not a required screening investigation)
- •18. Uncontrolled hypertension (defined as blood pressure consistently greater than 150/100 irrespective of medication), or controlled hypertension requiring use of more than two classes of anti-hypertensives
- •19. Uncontrolled hypokalemia and/or hypomagnesemia
- •20. Symptomatic peripheral vascular disease or cerebrovascular disease
- •21. Psychiatric disorders or other conditions rendering subjects incapable of complying with the requirements of the protocol
- •22. Receiving concurrent hormonal therapy with exception of gonadotropin-Releasing Hormone (GnRH) agonists in subjects with hormone refractory prostate cancer, Hormone Replcaement Therapy (HRT), oral contraceptive, and megestrol acetate used for anorexia/cachexia
- •23. Receiving anticoagulation with warfarin, heparin or low molecular weight heparin other than low dose (1 mg) warfarin for maintenance of central line patency
- •24. Women who are currently pregnant, nursing, or planning a pregnancy; or women who have a positive pregnancy test
- •25. Receiving concurrent antineoplastic therapy (radiation therapy, cytotoxic or biologic therapy)
研究者
相似试验
招募中
1 期
utetium-177-anti-Programmed Cell Death-Ligand 1 single domain antibodies (177Lu-anti-PD-L1 sdAb) in metastatic non-small cell lung cancerMetastatic Non-small Cell Lung CancerCancer - Lung - Non small cellACTRN12623000959673Radiopharm Theranostics Ltd23
已完成
1 期
A Phase I Study of SCC244 in Japanese Patients with Advanced Solid TumorsSolid tumorsJPRN-jRCT2080225124Shanghai Haihe Pharmaceutical Co., Ltd.6
尚未招募
1 期
Study to evaluate safety of LNP8701 in patients with different types of Metastatic solid cancersCTRI/2024/08/072373upin Limited
已完成
1 期
An Investigational Study of NKTR-214 Combined With Nivolumab in Japanese Participants With Advanced Solid TumorsJPRN-jRCT2080224176Bristol-Myers Squibb K.K.6
已完成
1 期
Safety Study of BMS-986016 With or Without Nivolumab in Subjects With Advanced Solid TumorsAdvanced Solid TumorsJPRN-jRCT2080223428Bristol-Myers Squibb K.K.27