Status:
RECRUITING
Trial in Patients With Metastatic or Locally Advanced Leiomyosarcoma
Lead Sponsor:
Italian Sarcoma Group
Collaborating Sponsors:
PharmaMar
Conditions:
Leiomyosarcoma of Ovary
Soft Tissue Sarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
The management of patients with leiomyosarcomas determines many difficulties. Despite patients with metastatic disease at diagnosis or who recur after initial treatment have a dismal prognosis and, ex...
Eligibility Criteria
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
- 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.
- Persistent toxicities with the exception of alopecia, caused by previous anticancer therapies
- Metastatic brain or meningeal tumors
- Active viral hepatitis
- Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus
- Patients with any severe and/or uncontrolled medical conditions
- 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
- Active clinically serious infections
- Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus
- 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 undergoing renal dialysis or with Creatinin Clearance \<30 ml/min or Creatinine \>1,5 mg/dL
- Pregnant or breast feeding patients
- 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
Key Trial Info
Start Date :
October 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04383119
Start Date
October 29 2021
End Date
December 31 2026
Last Update
January 2 2026
Active Locations (17)
Enter a location and click search to find clinical trials sorted by distance.
1
Azienda Ospedaliera S. Orsola-Malpighi
Bologna, BO, Italy, 40138
2
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST
Meldola, FC, Italy
3
Nuovo Ospedale di Prato
Prato, Firenze, Italy, 59100
4
Istituto Clinico Humanitas
Rozzano, MI, Italy, 20089