EUCTR2010-019866-96-IT进行中（未招募）不适用
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
试验速览
- 阶段
- 不适用
- 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 0,1 or 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
相似试验
进行中（未招募）
1 期
Study of Palifosfamide-tris in Combination with Doxorubicin in Patientswith Previously Untreated Metastatic Soft Tissue Sarcoma.metastatic soft tissue sarcomas, previously untreatedEUCTR2010-019866-96-BEZIOPHARM Oncology Inc424
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 IIImetastatic soft tissue sarcomasEUCTR2010-019866-96-GBZIOPHARM Oncology Inc424
Unknown
3 期
Study of Palifosfamide-tris in Combination With Doxorubicin in Patients With Front-line Metastatic Soft Tissue Sarcoma (a type of cancer)CTRI/2012/02/002401ZIOPHARM Oncology Inc424
已完成
3 期
BI 10773 add-on to Usual Care Compared With Usual Care Alone in Patients With Type 2 Diabetes Mellitus at High Cardiovascular RiskCardiovascular RiskCTRI/2011/05/001725Boehringer Ingelheim Pharmaceuticals4,000
进行中（未招募）
1 期
Efficacy, immunogenicity, and safety of the 9vHPV vaccine in adult males 20 to 45 years of ageMedDRA version: 20.1Level: LLTClassification code: 10063001Term: Human papilloma virus infection Class: 10021881Prevention of oral persistent infection caused by any of the human papillomavirus types 16, 18, 31, 33, 45, 52, and 58CTIS2022-501974-21-00Merck Sharp & Dohme LLC6,033