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
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
Treatments tested in this trial
- Trabectedin
Treatment groups
80 Participants
are divided into 1 treatment groupLocations
1Sant P Chawla90403, Santa MonicaCalifornia, United States
Sponsors and collaborators
Sarcoma Oncology Research Center, LLC
Lead sponsor
Source ClinicalTrials.gov