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

ZIOPHARM Oncology Inc0 个研究点目标入组 424 人开始时间: 待定最近更新: 2021年11月24日

研究概览

暂无简介。

•1. Age more than or equal to 18 years and less than 65 years.
•2. Documented soft tissue sarcoma
•3. Metastatic disease for which the patient has not received any prior treatment, and for whom treatment with doxorubicin is considered medically acceptable.
•4. ECOG Performance Status of 0, 1 or 2
•5. Adequate bone marrow and organ function based on the results of protocol- specified laboratory tests
•6. Male and female patients must agree to use a highly reliable method of birth control during study participation.
•7. Able to provide informed consent

•1. Age more than 65 years
•2. Specific sarcoma histological subtypes including GIST and Ewings sarcoma.
•3. Systemic therapy for the treatment of metastatic sarcoma, prior to or during the study. However, patients may have received neo-adjuvant/adjuvant Gemzar and Taxotere chemotherapy for their primary sarcoma, prior to the development of metastatic disease
•4. Any prior anthracycline use.
•5. Known allergy to any of the study drugs or their excipients.
•6. Any 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, based on screening tests, physical examination and medical history (as specifically defined in the clinical protocol).
•7. Myocardial dysfunction defined as left ventricular ejection fraction (LVEF) 50 percent.
•8. Documented metastases to brain or meninges.
•9. Any malignancy other than sarcoma within the last 5 years prior to screening, with the exception of cervical carcinoma in situ, basal cell carcinoma, or superficial bladder tumors (Ta, Tis, or T1) that have been successfully and curatively treated with no evidence of recurrent or residual disease.
•10. Currently pregnant or nursing.
•11. Radiotherapy with curative intent within 4 weeks of first dose of study drug.

发起方