EUCTR2010-019866-96-GB进行中（未招募）1 期
A Phase III multicenter, international, randomized, double-blind, placebo-controlled study of doxorubicin plus palifosfamide-tris vs. doxorubicin plus placebo in patients with front-line metastatic soft tissue sarcoma - PICASSO III
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 424
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 =18 years.
- •2. Histological documentation of soft tissue sarcoma
- •3. Metastatic disease for which the patient has not received any prior treatment
- •4. Measurable disease as per RECIST 1.1.
- •5. ECOG Performance Status of 0,1or 2
- •6. Adequate bone marrow, liver, and renal function (defined in protocol)
- •7. Written informed consent
- •8. Highly reliable method of birth control from the screening visit through 28 days after the last dose of study drug.
- •9. Negative urine pregnancy test performed within 21 days of the first day of study drug dosing (as appropriate).
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Has any one of the sarcoma histological subtypes listed as ineligible
- •2. Anticancer chemotherapy, anticancer immunotherapy, or any investigational drug therapy for the treatment of metastatic sarcoma, prior to or during the study.
- •3. Any prior anthracycline use.
- •4. Known allergy to any of the study drugs or their excipients.
- •5. Unstable or clinically significant concurrent medical condition that would, in the opinion of the investigator, jeopardize the safety of a patient and/or their compliance with the protocol.
- •6. Myocardial dysfunction defined as left ventricular ejection fraction (LVEF) <50%.
- •7. Baseline QTcF of > 450 msec.
- •8. Presence of, or history of any illness or injury to the urinary tract (renal or post-renal) which may make the patient more susceptible to acute renal insufficiency in the case of potential renal adverse events.
- •9. Active infection requiring systemic antibacterial/antibiotic, antifungal, or antiviral therapy.
- •10. Any major surgery (e.g., requiring general anaesthesia) within 6 weeks prior to start of treatment.
- •11. Documented metastases to brain or meninges.
- •12. Currently undergoing acute steroid therapy or taper.
- •13. Any malignancy other than sarcoma within the last 5 years prior to screening, with protocol-defined exceptions
- •14. Currently pregnant or nursing.
- •15. Substance abuse or medical, psychological, or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results, in the opinion of the investigator.
- •16. Radiotherapy with curative intent within 4 weeks of first dose of study drug, however, palliative external beam radiation to bone lesions is permitted if started or planned prior to Cycle 1, Day 1.
研究者
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