Trial · NCT07291297
Metformin Hydrochloride in Combination With Standard of Care Systemic Therapy in Previously Untreated Advanced Unresectable or Metastatic Soft Tissue Sarcoma
NCT07291297, Phase 2, Recruiting, Wake Forest University Health Sciences
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Metformin Hydrochloride in Combination With Standard of Care Systemic Therapy in Previously Untreated Advanced Unresectable or Metastatic Soft Tissue Sarcoma. Trials, record NCT07291297. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07291297
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Metformin Hydrochloride in Combination With Standard of Care Systemic Therapy in Previously Untreated Advanced Unresectable or Metastatic Soft Tissue Sarcoma
- NCT number
- NCT07291297
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 50 participants, estimated
- Lead sponsor
- Wake Forest University Health Sciences
- Conditions
- Sarcoma Metastatic, Sarcoma, Soft Tissue
- Interventions
- Metformin Hydrochloride ER
- First posted
- 2025-12-18
- Last updated
- 2026-07-23
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of participants surviving at 12 months | From date of metformin start to date of death, or censored at 12 months, whichever occurred first. | 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). |
| Secondary | Overall survival (OS) | From date of metformin start to date of death, or censored as described; assessed for approximately 5 years. | 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. |
| Secondary | Cancer specific survival | From date of metformin start to date of death, or censored as described; assessed for approximately 5 years. | 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. |
| Other | Metformin administration | From start of metformin treatment until last dose of study treatment; approximately 5 years | Descriptive summary of daratumumab administration, including number of courses received and number of doses received. |
| Other | Number of participants with at least one adverse event attributable to metformin | From start of metformin treatment until 30 days after last dose of study treatment; approximately 5 years | 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. |
| Other | Number of participants with at least one serious adverse event | From start of metformin treatment until 30 days after last dose of study treatment; approximately 5 years | 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. |
| Other | Number of participants who discontinued study treatment due to adverse events | From start of metformin treatment until 30 days after last dose of study treatment; assessed for approximately 5 years. | A binary variable will be determined for each participant indicating whether the participant discontinued metformin due to adverse events. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07291297
GET https://conductscience.org/api/trials/v1/NCT07291297/registered