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New treatment option for Sarcoma Metastatic
Official title Metformin Hydrochloride in Combination With Standard of Care Systemic Therapy in Previously Untreated Advanced Unresectable or Metastatic Soft Tissue Sarcoma
ClinicalTrials.gov ID: NCT07291297
What this study is testing
What is Metformin Hydrochloride ER?
Metformin Hydrochloride ER is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for sarcoma metastatic.
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
- The purpose of this research study is to see how metformin, when used in combination with standard of care (SOC) treatment for metastatic (cancer that has spread) soft tissue sarcoma can improve patient outcomes.
- 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
- Advanced unresectable or metastatic/intermediate/high grade soft tissue sarcoma
- Age ≥ 18 years at the time of enrollment
- Initiating first line systemic therapy for advanced/metastatic disease (treatment naïve for advanced/metastatic disease)
- Participants who have not yet initiated first line systemic therapy: expected to initiate front-line therapy within 4 weeks of initiating metformin
- Participants who have previously initiated first line systemic therapy: No more than 4 weeks from initiation of first line systemic therapy
You likely can't join if
- Already prescribed and taking metformin at time of diagnosis of advanced unresectable or metastatic disease
- Planned enrollment on a treatment clinical trial for first line therapy
- Breastfeeding within the duration of anticipated study treatment. NOTE: breast milk cannot be stored for future use while the mother is being treated...
- History of acute or chronic metabolic acidosis including diabetic ketoacidosis, with or without coma.
- Participants previously diagnosed with an additional malignancy must be disease-free for at least five years prior to enrollment. Exceptions include...
- Treatment with any investigational drug within 14 days prior to day 1 of treatment
See the full eligibility criteria
- Advanced unresectable or metastatic/intermediate/high grade soft tissue sarcoma
- Age ≥ 18 years at the time of enrollment
- Initiating first line systemic therapy for advanced/metastatic disease (treatment naïve for advanced/metastatic disease)
- Participants who have not yet initiated first line systemic therapy: expected to initiate front-line therapy within 4 weeks of initiating metformin
- Participants who have previously initiated first line systemic therapy: No more than 4 weeks from initiation of first line systemic therapy
- Adequate performance status (PS) defined as ECOG PS = 0-2
- Adequate renal function
- Adequate liver function
- Individuals of childbearing potential (ICBP) must have a negative serum pregnancy test within 7 days prior to enrollment. NOTE: Individuals who may become pregnant are considered to have childbearing potential unless...
- ICBP and partners of ICBP must not be expecting to conceive and be willing to use a highly effective contraceptive method (i.e., achieves a failure rate of \<1% per year when used consistently and correctly) from the...
- Individuals who are having sexual relationships in which their partners may become pregnant must be willing to use condoms from the time of informed consent until 30 days after study treatment discontinuation. For a...
- Ability to ingest oral medications
- Already prescribed and taking metformin at time of diagnosis of advanced unresectable or metastatic disease
- Planned enrollment on a treatment clinical trial for first line therapy
- Breastfeeding within the duration of anticipated study treatment. NOTE: breast milk cannot be stored for future use while the mother is being treated on study.
- History of acute or chronic metabolic acidosis including diabetic ketoacidosis, with or without coma.
- Participants previously diagnosed with an additional malignancy must be disease-free for at least five years prior to enrollment. Exceptions include ductal carcinoma in situ (DCIS), basal cell or squamous cell skin...
- Treatment with any investigational drug within 14 days prior to day 1 of treatment
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to metformin. Participants receiving any medications or substances that are inhibitors or inducers of CYP450 enzyme(s)...
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure requiring pharmacologic treatment, unstable angina pectoris, cardiac arrhythmia, or...
- Patients with known brain or active central nervous system (CNS) metastases.
The study team makes the final eligibility decision.
Where it's taking place
- Charlotte, North Carolina, United States
- Winston-Salem, North Carolina, 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 Charlotte, North Carolina, United States; Winston-Salem, North Carolina, 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.