Health TrialsbyHealthPanel

Metronomic Trabectedin, Gemcitabine, and Dacarbazine for Soft Tissue Sarcoma

ConditionLeiomyosarcoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSarcoma Oncology Research Center, LLC

About this trial

This is an open label phase 2 study using metronomic doses of trabectedin, gemcitabine and dacarbazine given intravenously.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or Female ≥ 18 years of age

Pathologically confirmed diagnosis of locally advanced, unresectable or metastatic leiomyosarcoma

Previously treated patient with measurable disease by RECIST v1.1

ECOG performance status ≤ 2

Disqualifiers

Currently receiving treatment with another investigational device or drug study, or <14 days since ending treatment with another investigational device or drug study(s).

Subject has known sensitivity to trabectedin, gemcitabine or dacarbazine.

Female subject is pregnant or breast-feeding or planning to become pregnant during study treatment and through 3 months after the last dose of trabectedin, gemcitabine or dacarbazine.

Female subject of childbearing potential who is unwilling to use acceptable method(s) of effective contraception during study treatment and through 3 months after the last dose of trabectedin, gemcitabine or dacarbazine.

Trial design

Design model

Single group

Treatments tested in this trial

  • Trabectedin

    Drug

    This is an open label phase 2 study using metronomic doses of trabectedin, gemcitabine and dacarbazine given intravenously.

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: Single armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Progression free survival

Progression free survival up to disease progression or death from any cause

Time frame
12 months

Secondary outcomes

1

Overall Response

Best overall response (BOR) and duration of response (DOR) by RECIST v1.1 via CT scan or MRI

Time frame
6 weeks
2

Adverse Event

Incidence of treatment-related adverse events

Time frame
12 months

Other outcomes

Sponsors and contacts

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

Sarcoma Oncology Research Center, LLC

Lead sponsor

Source ClinicalTrials.gov
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