Compares trabectedin with gemcitabine in advanced leiomyosarcoma patients

Trial details

Who runs it

Italian Sarcoma Group

Trial code

NCT04383119

Record updated

25 March 2026

Original description

Study is aimed at evaluating the activity of Trabectedin (arm A) in advanced leiomyosarcomas, having Gemcitabine (arm B) as the comparator.Read full original descriptionShow less

A Randomized Phase II Trial Comparing the Activity of trabectedIn vs Gemcitabine in Patients With Metastatic or Locally Advanced Leiomyosarcoma Pretreated With Conventional Chemotherapy

Study is aimed at evaluating the activity of Trabectedin (arm A) in advanced leiomyosarcomas, having Gemcitabine (arm B) as the comparator.

In addition to the randomized cohort, the study has also an observational prospective cohort which include patients who will refuse the randomization or for whom the investigator will not judge the randomization as an appropriate option.

In order to allow the participation of sites only to the prospective-observational (non randomized) cohort, it was introduced the possibility to participate to the study and receive the ethical approval only to the Observational Prospective Cohort In parallel an optional translational study will be performed, in both cohorts, to identify factors predictive of the activity of Trabectedin or Gemcitabine in this specific histotype.

Inclusion: Patients with histologically documented diagnosis of leiomyosarcoma; Patients with diagnosis of unresectable or metastatic leiomyosarcoma; Patients who received at least on previous systemic treatment with anthracycline-based chemotherapy; Patients suitable to receive gemcitabine or trabectedin therapy; Measurable or evaluable disease with RECIST 1.1 criteria; Evidence of progression according RECIST 1.1 during the 6 months before study entry; Age ≥18 years; Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2; All previous anticancer treatments must have completed ≥ 3 weeks prior to first dose of study drug; The patient has resolution of adverse events, with the exception of alopecia, and of all clinically significant toxic effects of prior loco-regional therapy, surgery, radiotherapy or systemic anticancer therapy to ≤ Grade 1, by National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0; Adequate bone marrow, liver and renal function; Left Ventricular Ejection Fraction ≥ 50% and/or above lower institutional limit of normality; Female patients of child-bearing potential must have negative pregnancy test within 7 days before initiation each cycle of chemotherapy; No history of arterial and/or venous thromboembolic event within the previous 12 months; 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 prior to any study specific procedure. The subject may also provide an optional consent for the biological/translational sub-study associated.

Exclusion: Prior treatment with Trabectedin and/or Gemcitabine; Persistent toxicities with the exception of alopecia, caused by previous anticancer therapies; Medical history of hemorrhage or a bleeding event ≥ Grade 3 (NCI-CTCAE v 5.0) within 4 weeks prior to the initiation of study treatment; Previous treatment with radiation therapy within 14 days of first day of study drug dosing,; Major surgery within 4 weeks prior to study entry; Concomitant use of known strong CYP3A inhibitors or moderate CYP3A inhibitors; Concomitant use of known strong or moderate CYP3A inducers; Patients with severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol; Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation of the study drugs; 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; Patients with any severe and/or uncontrolled medical conditions; Active clinically serious infections; Patients undergoing renal dialysis or with Creatinin Clearance <30 ml/min or Creatinine >1,5 mg/dL; Metastatic brain or meningeal tumors; Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus; Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus; Pregnant or breast feeding patients.

ClinicalTrials.gov NCT04383119