Metronomic Trabectedin, Gemcitabine, and Dacarbazine for Soft Tissue Sarcoma
Recruiting now · Phase 2
Conditions studied: Leiomyosarcoma
In brief
This is an open label phase 2 study using metronomic doses of trabectedin, gemcitabine and dacarbazine given intravenously.
Key facts
- Study ID
- NCT04535271
- Run by
- Sarcoma Oncology Research Center, LLC
- People needed
- 80
- Starts
- 2021-09-09
- Expected to finish
- 2029-03-30
- Last updated by the study team
- 2025-02-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Sant P Chawla — Santa Monica, California, United States (enrolling)
Full record on ClinicalTrials.gov
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