Study on Leiomyosarcoma, Liposarcomas and Synovial Sarcoma With Trabectedin

Trial details

Who runs it

Italian Sarcoma Group

Trial code

NCT03773510

Record updated

13 May 2019

Original description

Two arm, randomized, open-label study, to determine the best time to secondary resistance between responding patients who discontinue treatment and resumed Trabectedin at the time of progression versus patients who continued treatment until progression. TRead full original descriptionShow less

Time to Secondary Resistance to Trabectedin After Interruption Versus Continuation in Responding Patients With Liposarcoma, Leiomyosarcoma and Synovial Sarcoma

Two arm, randomized, open-label study, to determine the best time to secondary resistance between responding patients who discontinue treatment and resumed Trabectedin at the time of progression versus patients who continued treatment until progression. T

Inclusion: The patient or legal representative must be able to read and understand the informed consent form and must have been willing to give written informed consent and any locally required authorization before any study-specific procedures, including screening evaluations, sampling, and analyses; Diagnosis of well differentiated/dedifferentiated liposarcoma, mixoid round cell liposarcoma, leiomyosarcoma or synovial sarcoma; Persistent or locally relapsed and/or metastatic disease; Pathology specimens available for centralized review (central review is not mandatory prior to start the treatment, but within a month from screening, tumor sample must be sent to central pathology reviewer for a retrospective diagnosis confirmation); Age ≥ 18 years; Adequate bone marrow function; Adequate organ function,; Eastern Cooperative Oncology Group Performance Status ≤ 2; One or more previous systemic treatments with anthracyclines with or without ifosfamide (unless one or both are clinically contraindicated); Measurable disease. Patient who received radiotherapy within 3 weeks form the treatment start, can be included as long there is a measurable lesion outside of the irradiation field; A minimum of 3 weeks since any previous chemotherapy treatment; Recovery from toxic effects of prior therapies to (Grade 1 or lower); Female patients of child-bearing potential must have negative pregnancy test within 7 days before initiation each cycle of chemotherapy. Post-menopausal women must be amenorrhoeic for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential must agree to employ an effective method of birth control throughout the study.

Exclusion: Prior exposure to Trabectedin; Unstable cardiac condition, including congestive heart failure or angina pectoris, myocardial infarction within six months before enrollment, uncontrolled arterial hypertension or arrhythmia; Previous treatment with any other investigational or not investigational agents within 14 days of first day of study drug dosing; Other serious concomitant illnesses or any condition that may interfere with the subject's participation in the study or evaluation of the study results; History of other malignancies (except basal cell carcinoma or cervical carcinoma in situ, adequately treated), unless in remission from 5 years or more and judged of negligible potential of relapse; Active viral hepatitis or chronic liver disease; Active major infection; Known history of human immunodeficiency virus infection; Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation of the study drugs; Pregnant or breast-feeding women; Peripheral neuropathy, Grade 2 or higher; Known central nervous system metastases.

ClinicalTrials.gov NCT03773510