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SGR-2921 for Leukemia and Preleukemia

Phase 1

Recruiting

Research Sponsored by Schrödinger, Inc.

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 throughout the study, up to 26 months.

Awards & highlights

Study Summary

This trial will test a new drug to find what dose is safe and has the best result.

Who is the study for?

This trial is for adults over 18 with relapsed/refractory Acute Myeloid Leukemia or high-risk Myelodysplastic Syndrome. Participants should have a life expectancy of at least 8 weeks and be able to perform daily activities with some limitations (ECOG ≤2). Those who've had recent cancer treatments or other experimental drugs, heart rhythm issues, active cancers besides AML/MDS, severe blood clotting disorders, or leukemia in the brain/spine can't join.Check my eligibility

What is being tested?

The study is testing SGR-2921's safety and how well patients tolerate it. It aims to find the highest dose that doesn't cause unacceptable side effects (MTD) and/or suggest a dose for future studies (RD).See study design

What are the potential side effects?

Potential side effects are not specified but typically include reactions related to drug tolerance levels such as fatigue, nausea, allergic reactions, or more serious conditions depending on individual patient responses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ throughout the study, up to 26 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~throughout the study, up to 26 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout the study, up to 26 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adverse Events

Dose Limiting Toxicities

Electrocardiograms in Singlicate and Triplicate

Secondary outcome measures

Composite Complete Remission (CR) Rate for Subjects with AML

Duration of Response (DOR) for Subjects with AML

Duration of Response (DOR) for subjects with MDS

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Dose Escalation in the Presence of Specific Azole Antifungal TreatmentsExperimental Treatment1 Intervention

Up to 9 dose levels will be evaluated in subjects receiving specific azole antifungal treatment.

Group II: Dose Escalation in the Absence of Specific Azole Antifungal TreatmentsExperimental Treatment1 Intervention

Up to 9 dose levels will be evaluated in subjects not receiving specific azole antifungal treatment.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Schrödinger, Inc.Lead Sponsor

1 Previous Clinical Trials

52 Total Patients Enrolled

Daniel Weiss, M.D.Study DirectorSchrödinger, Inc.

1 Previous Clinical Trials

52 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities to join this research trial at the present?

"Data from clinicaltrials.gov affirms that this medical study is actively seeking participants, with the trial having been initially posted on September 1st 2023 and last edited on September 20th of the same year."

Answered by AI

Has the efficacy and safety of Dose Escalation been tested without an antifungal medication?

"Owing to the limited data surrounding its safety and efficacy, Dose Escalation in the Absence of Specific Azole Antifungal Treatments received a rating of 1."

Answered by AI

What is the greatest number of test subjects involved in this experiment?

"Correct. According to clinicaltrials.gov, this trial is presently recruiting participants and was first made available on September 1st 2023 with the most recent update being posted on September 20th of that same year. The research team needs 50 people from a single site for enrollment."

Answered by AI

What is the primary goal of this clinical investigation?

"This trial will span up to 26 months, measuring the primary outcome of electrocardiograms in singlicate and triplicate. Secondary outcomes include SGR-2921 time to maximal plasma concentration (tmax), SGR-2921 area under the concentration versus time curve (AUC), and composite complete remission rate for subjects with acute myeloid leukemia (AML)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of SGR-2921 in Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

2023. "Study of SGR-2921 in Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05961839.