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AG-946 for Myelodysplastic Syndrome
Phase 2
Waitlist Available
Research Sponsored by Agios Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
If taking iron chelation therapy, the iron chelation therapy dose must have been stable and started ≥56 days before administration of the first dose of study drug
2 forms of contraception, 1 of which must be considered highly effective, from the time of providing informed consent, throughout the study, and for 28 days after the last dose of study drug for women and 90 days after the last dose of study drug for men. The second form of contraception can be an acceptable barrier method
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 and week 8 (≤60 minutes predose and 0.5, 1, 2, 3, 4, 6, and 8 hours postdose) and at weeks 2, 4, 12, and 16 (≤60 minutes predose)
Awards & highlights
Study Summary
This trialtests a new drug to treat low-risk myelodysplastic syndrome (MDS). It'll compare its effects to placebo and look for dose response.
Who is the study for?
Adults with low-risk myelodysplastic syndromes (LR-MDS) and anemia can join this trial. They should have hemoglobin levels below 11.0 g/dL, a good performance status, and less than 5% bone marrow blasts. Participants must not be heavily dependent on blood transfusions and agree to use effective contraception if applicable.Check my eligibility
What is being tested?
The study is testing AG-946 against a placebo in two phases to see if it helps improve anemia in LR-MDS patients. Phase 2a establishes the concept while Phase 2b compares AG-946's effectiveness at different doses versus placebo.See study design
What are the potential side effects?
Specific side effects of AG-946 are not listed but may include typical reactions seen with other treatments for MDS such as fatigue, nausea, injection site reactions, or potential allergic responses to the drug's components.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been on a stable dose of iron chelation therapy for at least 56 days.
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I am using two forms of birth control, one highly effective, during and after the study.
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My MDS is classified as lower-risk with a score ≤3.5 and less than 5% blasts.
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I have been on a stable dose of iron chelation therapy for at least 56 days.
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I can take care of myself and am up and about more than half of my waking hours.
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I have received fewer than 3 blood transfusions in the last 4 months and none in the last 2 months.
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My MDS is classified as lower-risk with a score of ≤3.5 and less than 5% blasts.
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I am 18 years old or older.
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My MDS is classified as lower-risk with a score ≤3.5 and less than 5% blasts.
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I can take care of myself and am up and about more than half of my waking hours.
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I am able to care for myself and perform daily activities.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 and week 8 (≤60 minutes predose and 0.5, 1, 2, 3, 4, 6, and 8 hours postdose) and at weeks 2, 4, 12, and 16 (≤60 minutes predose)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 and week 8 (≤60 minutes predose and 0.5, 1, 2, 3, 4, 6, and 8 hours postdose) and at weeks 2, 4, 12, and 16 (≤60 minutes predose)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 2a: Number of Participants With Hemoglobin (Hb) Response
Blood Transfusion
Phase 2b: Number of Participants With Modified Hematologic Improvement-erythroid (mHI-E) Response
Secondary outcome measures
Phase 2a: Apparent Terminal Elimination Half-life (t½) of AG-946 During the Core Period
Phase 2a: Area Under the Concentration-time Curve From 0 to t Hours (AUC0-t) of AG-946 During the Core Period
Phase 2a: Area Under the Concentration-time Curve From 0 to the End of the Dosing Interval (AUC0-τ) of AG-946 During the Core Period
+29 moreTrial Design
8Treatment groups
Experimental Treatment
Placebo Group
Group I: Extension Period: AG-946 5 mgExperimental Treatment1 Intervention
At the discretion of the investigator, participants who received placebo in the Double-blind Period will receive AG-946, 5 mg orally, once daily for up to 156 weeks.
Group II: Extension Period: AG-946 3 mgExperimental Treatment1 Intervention
At the discretion of the investigator, participants who received placebo in the Double-blind Period will receive AG-946, 3 mg orally, once daily for up to 156 weeks.
Group III: Extension Period: AG-946 2 mgExperimental Treatment1 Intervention
At the discretion of the investigator, participants who received placebo in the Double-blind Period will receive AG-946, 2 mg orally, once daily for up to 156 weeks.
Group IV: Double-blind Period: Phase 2b - AG-946 5 mgExperimental Treatment1 Intervention
Participants will receive AG-946, 5 mg orally, once daily for up to 24 weeks.
Group V: Double-blind Period: Phase 2b - AG-946 3 mgExperimental Treatment1 Intervention
Participants will receive AG-946, 3 mg orally, once daily for up to 24 weeks.
Group VI: Double-blind Period: Phase 2b - AG-946 2 mgExperimental Treatment1 Intervention
Participants will receive AG-946, 2 mg orally, once daily for up to 24 weeks.
Group VII: Core Period: Phase 2a - AG-946 5 mgExperimental Treatment1 Intervention
Participants will receive AG-946, 5 milligrams (mg) orally, once daily for up to 16 weeks. At the discretion of the investigator, participants who complete Core Period will be eligible to receive the same dose in Extension Period for up to 156 weeks.
Group VIII: Double-blind Period: Phase 2b - Matching-placeboPlacebo Group1 Intervention
Participants will receive AG-946-matching placebo orally, once daily for up to 24 weeks.
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Who is running the clinical trial?
Agios Pharmaceuticals, Inc.Lead Sponsor
52 Previous Clinical Trials
4,090 Total Patients Enrolled
Medical Medical AffairsStudy ChairAgios Pharmaceuticals, Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been on a stable dose of iron chelation therapy for at least 56 days.My platelet count is below 50,000 without recent transfusions.I do not have any health conditions that my doctor thinks would make this study unsafe for me.I am using two forms of birth control, one highly effective, during and after the study.I have been on a stable dose of iron chelation therapy for at least 56 days.My MDS is classified as lower-risk with a score ≤3.5 and less than 5% blasts.I have had cancer before, but it was not active or treated in the last 5 years, except for certain skin, cervical, or breast cancers.I am using or willing to use two forms of birth control if I or my partner can become pregnant.I am not currently on antibiotics or have finished them at least 7 days ago.My kidney function is reduced, with an eGFR below 45 mL/min.I have been on a stable dose of iron chelation therapy for at least 56 days.My kidney function is reduced, with an eGFR below 45 mL/min.I haven't had serious heart or lung problems in the last 6 months.I stopped taking EPO or G-CSF at least 28 days ago, or luspatercept at least 65 days ago.I am not engaging in or will use contraception to prevent pregnancy during the trial.I have stopped taking EPO or G-CSF for at least 28 days, or luspatercept for at least 65 days, before starting the study drug.My MDS developed after treatment for another disease.I am not on antibiotics for an infection when I give my consent.I have not been treated with specific drugs for my condition, or if I have, it was only for a short time and long ago.I am allergic to AG-946 or its ingredients.I have been treated for high-risk MDS but not with specific drugs for more than a week in the last 8 weeks.I can take care of myself and am up and about more than half of my waking hours.You understand what the study involves and agree to follow all the study procedures.I am using or willing to use two forms of birth control if I or my partner can become pregnant.I haven't stopped P-gp inhibitors for the required time before joining.I have received fewer than 3 blood transfusions in the last 4 months and none in the last 2 months.My MDS is classified as lower-risk with a score of ≤3.5 and less than 5% blasts.I am 18 years old or older.My MDS is classified as lower-risk with a score ≤3.5 and less than 5% blasts.I have not had blood transfusions, or I have a specific transfusion history.I have had up to 2 treatments with drugs like EPO or luspatercept.I have been diagnosed with acute myeloid leukemia.I have fully recovered from any major surgery I had in the last 12 weeks.I have an active hepatitis C infection or tested positive for hepatitis B.I am allergic to AG-946 or its ingredients.I have fully recovered from any major surgery I had in the last 12 weeks.My trial is in Phase 2b.You are currently pregnant or breastfeeding.Your blood hemoglobin level is less than 11.0 grams per deciliter (g/dL) during the 4 weeks before the study.I can take care of myself and am up and about more than half of my waking hours.My platelet count is 75,000 or less without recent transfusions.I haven't stopped P-gp inhibitors for the required time before starting the study drug.I have a history of acute myeloid leukemia (AML).I have a history of liver or bile duct disorders.I am able to care for myself and perform daily activities.I am 18 years old or older.My trial is in Phase 2a.
Research Study Groups:
This trial has the following groups:- Group 1: Core Period: Phase 2a - AG-946 5 mg
- Group 2: Double-blind Period: Phase 2b - AG-946 2 mg
- Group 3: Double-blind Period: Phase 2b - AG-946 3 mg
- Group 4: Double-blind Period: Phase 2b - AG-946 5 mg
- Group 5: Double-blind Period: Phase 2b - Matching-placebo
- Group 6: Extension Period: AG-946 2 mg
- Group 7: Extension Period: AG-946 3 mg
- Group 8: Extension Period: AG-946 5 mg
Awards:
This trial has 0 awards, including: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.
Could you tell me the upper limit of participants in this medical trial?
"Affirmative. Clinicaltrials.gov's records show that the trial, published on October 20th 2022 and edited one day later, is still open to patient recruitment with 116 individuals required from a single study site."
Answered by AI
Has the FDA licensed AG-946 5 mg for use in a clinical setting?
"Our estimations at Power have rated the safety of Extension Period: AG-946 5 mg a 2, as this is currently only in Phase 2 and there has yet to be any proof that it can effectively target cancer cells."
Answered by AI
Are there any vacancies in the current clinical trial?
"According to information readily available on clinicaltrials.gov, this trial has been open for recruitment since October 20th 2022 and was most recently updated the following day."
Answered by AI
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