EUCTR2011-004927-11-HU进行中（未招募）不适用
A Multicenter, Randomized, Open-Label Phase 2b Study to Investigate the Preliminary Efficacy and Safety of INNO-206 (Doxorubicin-EMCH) Compared to Doxorubicin in Subjects with Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcoma - NA
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 105
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
- •1.Age between 15-80 years (US only), and 18-80 (rest of world (ROW)), male or female.
- •2.Adjuvant or neoadjuvant chemotherapy (including doxorubicin) allowed if no tumor recurrence for at least 12 months since the last measurement, beginning or end of last chemotherapy.
- •3.Histologically or cytologically confirmed, locally advanced, unresectable, and/or metastatic soft tissue sarcoma of intermediate or high grade.
- •4.Capable of providing informed consent and complying with trial procedures.
- •5.ECOG performance status 0-2.
- •6.Life expectancy >12 weeks.
- •7.Measurable tumor lesions according to RECIST 1.1 criteria.
- •8.Women must not be able to become pregnant (eg post-menopausal for at least 1 year, surgically sterile, or practicing adequate birth control methods) for the duration of the study. (Adequate contraception includes: oral contraception, implanted contraception, intrauterine device implanted for at least 3 months, or barrier method in conjunction with spermicide.)
- •9.Women of child bearing potential must have a negative serum or urine pregnancy test at the Screening Visit and be non-lactating.
- •10.Geographic accessibility to the site that ensures the subject will be able to keep all study-related appointments.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 5
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1.Prior chemotherapy unless for adjuvant or neoadjuvant therapy with no tumor recurrence for at least 12 months.
- •2.Prior exposure to >3 cycles or 225 mg/m2 of doxorubicin or Doxil®.
- •3.Palliative surgery and/or radiation treatment less than 4 weeks prior to Randomization.
- •4.Exposure to any investigational agent within 30 days of Randomization.
- •5.Current Stage 1 or 2 soft tissue sarcomas.
- •6.Current evidence/diagnosis of alveolar soft part sarcoma, chondrosarcoma, rhabdomyosarcoma, osteosarcoma, gastrointestinal stromal tumor (GIST), dermatofibrosarcoma, Ewing’s sarcoma, Kaposi’s sarcoma, mixed mesodermal tumor, clear cell sarcomas and unresectable low grade liposarcomas.
- •7.Central nervous system metastasis
- •8.History of other malignancies except cured basal cell carcinoma, superficial bladder cancer or carcinoma in situ of the cervix unless documented free of cancer for >5 years.
- •9.Laboratory values: Screening serum creatinine >1.5xULN, alanine aminotransferase (ALT) > 3×ULN, or >5×ULN if liver metastases are present, total bilirubin >3×ULN, absolute neutrophil count <1,500/mm3, platelet concentration <100,000/mm3, hematocrit level <25% for females or <27% for males, coagulation tests (PT, PTT, INR) >1.5×ULN, and albumin <2.0 g/dL.
- •10.Clinically evident congestive heart failure > class II of the New York Heart Association (NYHA) guidelines.
- •11.Current, serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia or ventricular arrhythmias classified as Lown III, IV or V.
- •12.Baseline QTc >470 msec and/or previous history of QT prolongation while taking other medications. Concomitant use of medications associated with a high incidence of QT prolongation is not allowed
- •13.History or signs of active coronary artery disease with or without angina pectoris.
- •14.Serious myocardial dysfunction defined as scintigraphically (eg MUGA, myocardial scintigram) or ultrasound determined absolute left ventricular ejection fraction (LVEF) <45% of predicted.
- •15.History of HIV infection.
- •16.Active, clinically significant serious infection requiring treatment with antibiotics, anti-virals or anti-fungals.
- •17.Major surgery within 3 weeks prior to Randomization.
- •18.Substance abuse or any condition that might interfere with the subject’s participation in the study or in the evaluation of the study results.
- •19.Any condition that is unstable and could jeopardize the subject’s participation in the study.
研究者
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