EUCTR2009-017432-40-AT进行中（未招募）1 期
A Phase 2, Randomized, Double-blind, Placebo-controlled, Multi-Center Clinical Study to Evaluate Efficacy and Safety of a Maintenance Therapy with Immunomodulator MGN1703 in Patients with Advanced Colorectal Carcinoma with Disease Control after Initial First-line Therapy (IMPACT Study) - IMPACT Study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- MOLOGEN AG
- 入组人数
- 129
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
- •Subjects fulfilling the following criteria are eligible for participation in the study:
- •1. Male and female subjects older than 18 years of age
- •2. Histologically confirmed colorectal carcinoma
- •3. Radiological confirmation of unresectable advanced colorectal carcinoma (AJCC Stage IV) prior to start of initial first-line therapy
- •4. At least one measurable lesion according to RECIST measured within 2 weeks prior to treatment start in case of partial response or stable disease
- •5. Prior initial first-line therapy included oral or intravenous fluoropyrimidines/leucovorin, irinotecan or oxaliplatin with or without a standard dose of bevacizumab lasted between 4.5 and 6 months and finished (last day of last cycle) within 2 weeks prior to treatment start (treatment duration with irinotecan or oxaliplatin should not be less than 3 months)
- •6. Patients who achieved disease control measured as objective response or disease stabilization after initial first-line therapy
- •7. No curative standard therapy is available for the patient after first-line treatment
- •8. ECOG performance status 0-1
- •9. Adequate organ function, hemoglobin = 9 g/L, white blood cell count (WBC) = 3.0 x 109/L, absolute neutrophil count = 1.5 x 109/L, platelets > 100 x109/L, aspartate and alanine aminotransferase (AST and ALT) = 2.5 x ULN, bilirubin < 1.5 x ULN, blood creatinine = 1.5 X ULN, prothrombin time (PT) and activated thromboplastin time (aPTT) within normal range
- •10. Negative pregnancy test in women with childbearing potential
- •11. Expected adequacy of follow-up
- •12. Signed informed consent form (ICF).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 129
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 129
排除标准
- •Subjects who meet any of the following criteria will be excluded from the study:
- •1.More than one line of systemic chemotherapy for metastatic colorectal carcinoma
- •2.Tumor progression after initial first-line therapy
- •3.Clinically significant concomitant diseases or conditions unrelated to the underlying malignancy or chemotherapy, which in opinion of the investigator would lead to an unacceptable risk for the subject to participate in the study
- •4.Prior or current other malignancy, except adequately treated superficial bladder cancer, basal or squamous cell carcinoma of the skin or other cancer for which the subject has been disease free for more than 3 years
- •5.Known central nervous system metastases
- •6.Active or uncontrolled infections
- •7.Transfusion-dependent anemia
- •8.History of autoimmune disease or immune deficiency
- •9.Known hypersensitivity to oligonucleotides or excipients of the formulation
- •10.Pregnancy and/or nursing
- •11.Concurrent chronic systemic immune therapy or immunosuppressant medication, including steroid treatment
- •12.Concurrent chemotherapy, hormonal therapy (except hormonal contraception and hormonal replacement therapy for menopausal women), or immunotherapy within the last 2 weeks prior to randomization or during the conduct of the study
- •13.Concurrent radiotherapy within the last 6 months prior to randomization or during the conduct of the study
- •14.HIV seropositivity or active hepatitis B or C infection
- •15.Planned major surgery during the study
- •16.Participation in another clinical study with other investigational drugs within 14 days prior to the first treatment day
- •17.Vaccination within 3 months prior to the first treatment day
- •18.Any medical, mental, psychological or psychiatric condition which in opinion of the investigator would not permit the subject to complete the study or understand the patient information
- •19.Presence of drug and/or alcohol abuse.
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