Metronomic Trabectedin, Gemcitabine, and Dacarbazine for Soft Tissue Sarcoma
Key facts
- Where
- Santa Monica, United StatesSee the site
- Phase
- Phase 2
Where in United States
- Sant P ChawlaSanta Monica, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sarcoma Oncology Research Center, LLC
- Trial code
- NCT04535271
- Record updated
- 24 February 2025
- Original description
This is an open label phase 2 study using metronomic doses of trabectedin, gemcitabine and dacarbazine given intravenously.Read full original descriptionShow less
TAGGED: A Phase 2 Study Using Low Dose/Metronomic Trabectedin, Gemcitabine, and Dacarbazine as 2nd/3rd/4th Line Therapy for Advanced Soft Tissue Sarcoma
This is an open label phase 2 study using metronomic doses of trabectedin, gemcitabine and dacarbazine given intravenously.
Inclusion: 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; Life expectancy of at least 3 months; Acceptable liver function: Bilirubin < 1.5 times upper limit of normal (ULN; except subjects with Gilbert Syndrome who must have a total bilirubin level < 3.0 ULN); AST (SGOT), ALT (SGPT) and alk phos < 2.5 x ULN (< 5 x ULN if liver metastases present); Acceptable renal function: Creatinine < 1.5 times ULN and creatinine clearance > 60 ml/min using the Crockroft-Gault formula; Acceptable hematologic status: ANC >1000 cells/μL; Platelet count >100,000/μL; Hemoglobin > 9.0 g/dL; INR and PT < 1.5 ULN unless taking anti-coagulation, in which case PT, INR and aPTT must be within therapeutic range of intended use of anticoagulants; Ability to understand the purposes and risks of the study and has signed and dated a written informed consent form approved by the Investigator's IRB/Ethics Committee; Willingness to comply with all study procedures and availability for the duration of the study; All women of childbearing potential must have a negative urine or serum pregnancy test within 72 hours of enrollment. If urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required; all subjects must agree to use highly effective means of contraception (surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) with their partner from entry into the study through 5 months for women and 7 months for men after the last dose.
Exclusion: 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; Sexually active subjects and their partners unwilling to use male or female latex condom.