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Trial in Patients With Metastatic or Locally Advanced Leiomyosarcoma

ConditionsLeiomyosarcoma of OvarySoft Tissue Sarcoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorItalian Sarcoma Group

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • Trabectedin

    Drug

    Trabectedin in monotherapy

  • Gemcitabine

    Drug

    Gemcitabine, control arm

  • No Intervention: Observational Cohort

    Drug

    Treatment according clinical practice

Treatment groups

100 Participants
are divided into 3 treatment groups
Group A: Arm AExperimental treatment 1 intervention
Group B: Arm BActive comparator 1 intervention
Group C: Observational CohortActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Compare the Growth Modulation Index (GMI) in patients treated with Trabectedin or Gemcitabine in second line

Ratio of Time To Progression with the nth line (TTPn) of therapy to the TTPn-1 with the n-1th line.

Time frame
Week 6, week 12, week 18, week 27, week 36 and week 45

Secondary outcomes

1

Overall Response Rate

Overall response rate according Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

Time frame
Week 6, week 12, week 18, week 27, week 36 and week 45
2

Overall Survival (OS)

Survival from the first dose treatment to death for any cause

Time frame
3 years and 5 years
3

Progression free Survival (PFS)

Survival without disease progression

Time frame
6 months
4

Duration of response

Duration of tumor control according Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

Time frame
Week 6, week 12, week 18, week 27, week 36 and week 45

Other outcomes

1

Exploratory objectives

Identify gene mutations that may be associated to response/resistance to the treatment and to clinical outcomes parameters.

Time frame
week 6, and at up to week 53

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Italian Sarcoma Group

Lead sponsor

PharmaMar

Collaborator

Source ClinicalTrials.gov
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