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Enzyme Inhibitor
CPI-613 + Metformin for Acute Myeloid Leukemia
Phase 2
Waitlist Available
Led By Bayard Powell, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days after last dose of study treatment
Awards & highlights
Study Summary
This trial studies the effects of combining two drugs to treat relapsed or resistant acute myeloid leukemia or granulocytic sarcoma.
Who is the study for?
This trial is for adults with relapsed or refractory Acute Myeloid Leukemia or granulocytic sarcoma. Participants must be in a stable condition, not pregnant, willing to use contraception, and have acceptable organ function. Those breastfeeding, with active brain tumors, on other cancer treatments within the last week (except certain medications), or unable to follow the study plan are excluded.Check my eligibility
What is being tested?
The trial studies the effects of combining metformin and CPI-613 on patients whose acute myeloid leukemia has returned after treatment or didn't respond initially. It involves regular blood draws and bone marrow biopsies to monitor responses.See study design
What are the potential side effects?
Potential side effects may include reactions at injection sites, changes in blood sugar levels due to metformin, fatigue, gastrointestinal issues like nausea or diarrhea from both drugs, liver enzyme alterations, and possible low blood cell counts leading to increased infection risk.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 30 days after last dose of study treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days after last dose of study treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants to Receive at Least One Cycle of Maintenance Therapy - Feasibility
Secondary outcome measures
Number of Reported Adverse Events - Safety
Overall Survival
Response Rate - Efficacy (Acute Myeloid Leukemia European LeukemiaNet 2022)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment - CPI-613 with MetforminExperimental Treatment4 Interventions
Induction therapy with CPI-613 and Metformin (ideally 2 hours prior to start of CPI-613 infusions on days 1-5) for two cycles of treatment.
Maintenance therapy with CPI-613 and Metformin (ideally 2 hours prior to start of CPI-613 infusions on days 1-5) until progression, intolerable toxicity of withdrawal of consent.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metformin
2006
Completed Phase 4
~2430
Blood draws
2010
Completed Phase 2
~520
Bone marrow biopsy
2017
Completed Phase 2
~60
Find a Location
Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,240 Previous Clinical Trials
1,004,190 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,650 Total Patients Enrolled
Cornerstone PharmaceuticalsIndustry Sponsor
13 Previous Clinical Trials
844 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a tumor in my brain or spinal cord.I have a central venous catheter or am willing to get one.I understand the study details and am willing to sign the consent form.I am not pregnant or using effective birth control.I can take care of myself but may not be able to do heavy physical work.I am 18 years old or older.My side effects from previous treatments are mild.My leukemia has returned or didn't respond to treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment - CPI-613 with Metformin
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment currently available for this medical experiment?
"The listing on clinicaltrials.gov states that recruitment for this specific trial has been suspended, with the original post dating back to June 1st of 2023 and last update occurring May 10th of the same year. However, there are still 1507 other trials actively recruiting right now."
Answered by AI
Has the FDA sanctioned CPI-613 in combination with Metformin as a viable remedy?
"Due to the lack of data supporting its efficacy, Treatment - CPI-613 with Metformin received a score of 2 for safety. This is in part due to it being a Phase 2 trial and thus having only limited research available on its effects."
Answered by AI
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