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New treatment option for Leiomyosarcoma of Ovary
Official title Trial in Patients With Metastatic or Locally Advanced Leiomyosarcoma
ClinicalTrials.gov ID: NCT04383119
What this study is testing
What is Trabectedin?
Trabectedin is an investigational medicine, being studied as a potential treatment for leiomyosarcoma of ovary.
Also referred to as Trabectedin arm.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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...
- Persistent toxicities with the exception of alopecia, caused by previous anticancer therapies
- Metastatic brain or meningeal tumors
- Active viral hepatitis
See the full eligibility criteria
- 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 ≤...
- 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...
- 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 \ 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
The study team makes the final eligibility decision.
Where it's taking place
- Bologna, BO, Italy
- Meldola, FC, Italy
- Prato, Firenze, Italy
- Rozzano, MI, Italy
- Aviano, PD, Italy
- Roma, RM, Italy
- Candiolo, Torino, Italy
- Orbassano, Torino, Italy
- Bologna, Italy
- Genova, Italy
- Milan, Italy
- Naples, Italy
- Padova, Italy
- Palermo, Italy
- Rome, Italy
- Torino, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bologna, BO, Italy; Meldola, FC, Italy; Prato, Firenze, Italy; Rozzano, MI, Italy; Aviano, PD, Italy; Roma, RM, Italy and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.