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New treatment option for Sarcoma
Official title GALLANT: Metronomic Gemcitabine, Doxorubicin, Docetaxel and Nivolumab for Advanced Sarcoma
ClinicalTrials.gov ID: NCT04535713
What this study is testing
What is Gemcitabine?
Gemcitabine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for sarcoma.
Also referred to as Gemzar.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is an open label phase 2 study for advanced sarcoma using metronomic doses of gemcitabine, doxorubicin and docetaxel, and nivolumab immunotherapy given intravenously.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Pathologically confirmed diagnosis of locally advanced, unresectable or metastatic sarcoma
- 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...
- Willingness to comply with all study procedures and availability for the duration of the study.
- Previously treated patient with measurable disease by RECIST v1.1
- ECOG performance status ≤ 2
You likely can't join if
- History or evidence of active autoimmune disease that requires systemic treatment (ie, with use of disease modifying agents, corticosteroids or...
- Currently receiving treatment with another investigational device or drug study, or \<14 days since ending treatment with another investigational...
- Subject has known sensitivity to gemcitabine, doxorubicin, docetaxel or nivolumab.
- Female subject is pregnant or breast-feeding or planning to become pregnant during study treatment and through 3 months after the last dose of...
- Female subject of childbearing potential who is unwilling to use acceptable method(s) of effective contraception during study treatment and through 3...
- Sexually active people and their partners unwilling to use male or female latex condom
See the full eligibility criteria
- Pathologically confirmed diagnosis of locally advanced, unresectable or metastatic sarcoma
- 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.
- Previously treated patient with measurable disease by RECIST v1.1
- ECOG performance status ≤ 2
- Life expectancy of at least 3 months
- Acceptable cardiac function with LV ejection fraction of \> 50%
- Acceptable liver function: Bilirubin \< 1.5 times upper limit of normal (ULN; except people 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...
- Acceptable renal function: Creatinine \ 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
- 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...
- History or evidence of active autoimmune disease that requires systemic treatment (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or...
- 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 gemcitabine, doxorubicin, docetaxel or nivolumab.
- Female subject is pregnant or breast-feeding or planning to become pregnant during study treatment and through 3 months after the last dose of gemcitabine, doxorubicin, docetaxel or nivolumab.
- 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 gemcitabine, doxorubicin, docetaxel or...
- Sexually active people and their partners unwilling to use male or female latex condom
The study team makes the final eligibility decision.
Where it's taking place
- Santa Monica, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Santa Monica, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.