EUCTR2016-001459-28-GB进行中（未招募）1 期
A Novel Phase I/IIa Open label Study of IMM 101 in Combination with Selected Standard of Care (SOC) Regimens in Patients with Metastatic Cancer or Unresectable Cancer at Study Entry. - MODULATE
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 2
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
- •Patients are eligible to be included in the study if they:
- •1. Have metastatic or unresectable cancer and are considered by their physician to be indicated for a new line of SOC chemotherapy, as listed
- •2. Are ineligible for a disease specific clinical study with IMM 101
- •3. Have an estimated life expectancy greater than 3 months (from Day 0)
- •4. Give signed informed consent for participation in the study
- •5. Have an Eastern Cooperative Oncology Group (ECOG)/World Health Organisation (WHO) Performance Status of =2 at Day 0.
- •6. Have adequate bone marrow, hepatic and renal function including the following:
- •a.Haemoglobin (Hb) =9.0g/dL, absolute neutrophil count =1.5 x 109/L, platelets =75 x 109/L
- •b.Total bilirubin =1.5 x upper limit of normal (ULN), excluding cases where elevated bilirubin can be attributed to Gilbert's Syndrome
- •c. Aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT]), alanine transaminase (ALT; serum glutamate pyruvate transaminase [SGPT]) =5 x ULN
- •d. Creatinine =1.5 x ULN
- •e. Serum albumin >28g/L
- •f. International normalised ratio (INR) <1.5 or a prothrombin time/partial thromboplastin time (Pt/PTT) within normal limits
- •g. C reactive protein (CRP) <20 mg/L for patients with solid tumours
- •7. Are aged =18 years.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 150
排除标准
- •Patients will be ineligible if one or more of the following statements are applicable:
- •1. Patient has previously received treatment with IMM 101
- •2. Patient is currently part way through a course of chemotherapy
- •3. Patient is receiving concomitant treatment with another investigational product
- •4. Patient has received an investigational drug within the 4 weeks prior to IMM-101 administration
- •5. Patient has significant cardiovascular disease as defined by:
- •a. History of congestive heart failure requiring therapy
- •b. History of unstable angina pectoris or myocardial infarction up to 6 months prior to study entry
- •c. Presence of valvular heart disease
- •d. Presence of a ventricular or supra ventricular arrhythmia requiring ongoing treatment
- •e. Left ventricular ejection fraction (LVEF) <50% (or less than the institutional norm)
- •6. Patient has any previous or concurrent malignancy. Patients will not be excluded if they have adequately treated carcinoma in situ of the cervix, basal cell carcinoma of the skin and/or non melanoma skin cancer, or if previous malignancy was more than 5 years prior to Screening and there are no signs of recurrence
- •7. Patient has co existing active infection or medical condition which, in the Investigator’s judgement, will substantially increase the risk associated with the patient’s participation in the study
- •8. Patient has uncontrolled hypercalcaemia (National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events [CTCAE] v4.0[1] >Grade 1)
- •9. Patient is pregnant or a breast feeding woman. Female patients with reproductive potential must have a negative serum pregnancy test (ß human chorionic gonadotropin [ß hCG]) within 72 hours prior to start of the study. Both women and men must agree to use a medically acceptable, effective method of contraception throughout the treatment period and for 3 months after discontinuation of treatment. Acceptable, effective methods of contraception include intrauterine device (IUD), intrauterine hormone releasing system (IUS), oral contraceptive (progestogen only oral contraception that does not inhibit ovulation is not an acceptable method), bilateral tubal occlusion, vasectomised partner, and subdermal implant
- •10. Patient has used depot corticosteroids in the 6 weeks before initiation of Screening (signing of the informed consent form [ICF])
- •11. Patient has had chronic use of systemic corticosteroids (>10 mg per day of prednisolone or equivalent for a period of 2 weeks or more) and/or immunosuppressant drugs (such as azathioprine, tacrolimus, cyclosporin) within the 2 week period before the first administration of IMM-101
- •12. Patient has received a blood transfusion within 4 weeks prior to Screening
- •13. In the opinion of the Investigator, the patient is unable or unwilling to comply with the protocol
研究者
相似试验
终止
1 期
Study of IMM 101 in Combination With Standard of Care in Patients With Metastatic or Unresectable CancerMetastatic CancerNCT03009058Immodulon Therapeutics Ltd2
进行中（未招募）
1 期
IMM101 treatment, combined with CyberKnife, in Colorectal CancerMetastatic colorectal cancerMedDRA version: 14.0 Level: PT Classification code 10061451 Term: Colorectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-003958-85-GBImmodulon Therapeutics Ltd12
进行中（未招募）
1 期
Phase II Randomized, Open-Label Study of IMC-1121B With or Without Dacarbazine in Patients with Metastatic Malignant MelanomaMetastatic Malignant MelanomaMedDRA version: 9.1 Level: LLT Classification code 10027480 Term: Metastatic malignant melanomaEUCTR2007-006713-16-GBImClone Systems Incorporated104
进行中（未招募）
不适用
A clinical trial studying Paclitaxel with or without MM-121 for patients with advanced ovarian cancerEUCTR2011-003576-36-ESMERRIMACK PHARMACEUTICALS210
进行中（未招募）
1 期
A clinical trial studying Paclitaxel with or without MM-121 for patients with advanced ovarian cancerPatient with Platinum Resistant/Refractory Advanced Ovarian Cancers.MedDRA version: 14.1Level: PTClassification code 10033128Term: Ovarian cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-003576-36-BEMERRIMACK PHARMACEUTICALS210