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.
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
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.
Single group
Metformin Hydrochloride ER
DrugParticipants will initially take 1000mg ER of metformin by mouth daily for 14 days, in combination with physician directed SOC systemic therapy for advanced unresectable or metastatic STS.
Number of participants surviving at 12 months
12-month overall survival (OS) will be determined for each participant as a binary variable indicating whether the participant was surviving at 12 months after study enrollment. Failure occurs if the participant dies from any cause within 12 months of study enrollment (initiation of metformin).
Overall survival (OS)
OS is defined as the duration of time from initiation of metformin to date of death from any cause. Surviving participants will be censored at the last known date they were alive.
Cancer specific survival
Cancer specific survival is defined as the duration of time from initiation of metformin to date of sarcoma-related death. For participants who die from causes unrelated to sarcoma, cancer-specific survival will be calculated at the date of death, with non-cancer specific death as a competing risk event. Surviving participants will be censored at the last known date they were alive.
Metformin administration
Descriptive summary of daratumumab administration, including number of courses received and number of doses received.
Number of participants with at least one adverse event attributable to metformin
A binary variable will be determined for each participant indicating whether the participant had at least one metformin-attributed adverse event. Adverse events will be categorized per NCI Common Terminology for Adverse Events version 5.0. Metformin attribution will be determined per treating investigator.
Number of participants with at least one serious adverse event
A binary variable will be determined for each participant indicating whether the participant had at least one adverse event that was categorized as serious, regardless of causality. Serious is defined per the study protocol and includes events that the investigator deems serious and results in the following outcomes: death, life-threatening situation, persistent or significant disability/incapacity, requires or prolongs hospitalization, congenital anomaly/birth defect in the offspring of a study participant, suspected transmission of any infectious agent via medial product, or based upon medical judgement, may jeopardize the subject and may require medical or surgical intervention to prevent one of the afore listed outcomes from occurring.
Number of participants who discontinued study treatment due to adverse events
A binary variable will be determined for each participant indicating whether the participant discontinued metformin due to adverse events.
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Wake Forest University Health Sciences
Lead sponsor
Atrium Health Levine Cancer Institute
Collaborator
Paula Takacs Foundation
Collaborator
