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Study of Radiolabeled SNDX-5613 in Adults With Acute Leukemia

Primary Purpose

Acute Leukemia

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

SNDX-5613

About this trial

This is an interventional treatment trial for Acute Leukemia focused on measuring SNDX-5613, Acute Leukemia, Refractory leukemia, Relapsed leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

Males aged 18 and older.
Relapsed or refractory acute leukemia (AML/ALL or MPAL), including participants who are MRD-positive by multiparametric flow cytometry or next-generation sequencing, and including participants with isolated extramedullary disease.
Recurrent/relapsed or refractory acute leukemia after standard of care therapy
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
Adequate liver and cardiac function
Fertile males agree to use barrier contraception from the time of enrollment through 120 days after the last study drug dose

Key Exclusion Criteria:

Active diagnosis of acute promyelocytic leukemia
White blood cell (WBC) count >25,000/microliters at time of enrollment.
Detectable human immunodeficiency virus viral load within the previous 6 months
Hepatitis B or Hepatitis C
Cardiac, gastrointestinal, or graft-versus-host disease (GVHD)
Concurrent malignancy in the previous 2 years except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin, low-grade lymphoma that does not require treatment, or carcinoma in situ treated with potentially curative therapy
History of or any concurrent condition, therapy, laboratory abnormality, or allergy to excipients that might confound the results of the study, interfere with the participant's ability to participate for the full duration of the study, or not be in the best interest of the participant to participate
Must not be receiving any moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitor/inducers
Any commercially available or investigational antileukemic therapy other than SNDX-5613 except for short-term administration of corticosteroids and/or hydroxyurea for cytoreduction
Participation in another therapeutic interventional clinical study in which an investigational agent was administered within 30 days before starting SNDX-5613
Any concurrent systemic treatment to prevent GVHD

Sites / Locations

MD Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SNDX-5613

Arm Description

Participants will be administered a single dose of SNDX-5613 (containing ~100 microcuries [14C]-SNDX-5613) in the AME part of the study. Each dose administered after the first dose in the AME part of the study will be nonradiolabeled SNDX-5613. SNDX-5613 may continue to be administered following completion of the AME part of the study. Doses will be administered in continuous 28-day cycles until either PD or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Percentage of Dose Excreted in Urine (feu)

Percentage of Dose Excreted in Feces (fef)

Amount Excreted in Urine (Aeu)

Amount Excreted in Feces (Aef)

Area Under The Concentration Time Curve from Time 0 to The Last Measurable Concentration (AUC0-t)

Maximum Observed Concentration (Cmax)

Secondary Outcome Measures

Number of Participants with Treatment-emergent Adverse Events (TEAEs)

Full Information

NCT ID

NCT05406817

First Posted

June 1, 2022

Last Updated

July 14, 2023

Sponsor

Syndax Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT05406817

Brief Title

Study of Radiolabeled SNDX-5613 in Adults With Acute Leukemia

Official Title

A Phase 1, Open-label Study to Assess the Mass Balance, Pharmacokinetics, and Metabolism of Orally Administered [14C]-SNDX-5613 in Patients With Relapsed/Refractory Acute Leukemia

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 5, 2022 (Actual)

Primary Completion Date

May 2024 (Anticipated)

Study Completion Date

September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Syndax Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

This is an open-label study to evaluate the absorption, metabolism, and excretion (AME) of carbon-14 ([14C])-SNDX-5613 in participants with acute leukemia.

Detailed Description

Participants will be enrolled in this study primarily to complete the 11-day AME portion of the study; participants who are receiving benefit from SNDX-5613 may remain on study until progressive disease (PD) or unacceptable toxicity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Leukemia

Keywords

SNDX-5613, Acute Leukemia, Refractory leukemia, Relapsed leukemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

8 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

SNDX-5613

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

SNDX-5613

Intervention Description

Initial radiolabeled SNDX-5613 will be administered as an oral solution. Capsules will be administered thereafter.

Primary Outcome Measure Information:

Title

Percentage of Dose Excreted in Urine (feu)

Time Frame

Up to Day 11

Title

Percentage of Dose Excreted in Feces (fef)

Time Frame

Up to Day 11

Title

Amount Excreted in Urine (Aeu)

Time Frame

Up to Day 11

Title

Amount Excreted in Feces (Aef)

Time Frame

Up to Day 11

Title

Area Under The Concentration Time Curve from Time 0 to The Last Measurable Concentration (AUC0-t)

Time Frame

Up to Day 21

Title

Maximum Observed Concentration (Cmax)

Time Frame

Up to Day 21

Secondary Outcome Measure Information:

Title

Number of Participants with Treatment-emergent Adverse Events (TEAEs)

Time Frame

up to approximately 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: Males and females (of non-childbearing potential) aged ≥18 years Relapsed or refractory acute leukemia, including participants who are MRD-positive by multiparametric flow cytometry or next-generation sequencing, and including participants with isolated extramedullary disease. Previously received standard of care therapy Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2 Adequate liver and cardiac function Fertile males agree to use barrier contraception from the time of enrollment through 120 days after the last study drug dose Key Exclusion Criteria: Active diagnosis of acute promyelocytic leukemia White blood cell (WBC) count >25,000/microliters at time of enrollment. Detectable human immunodeficiency virus viral load within the previous 6 months Hepatitis B or Hepatitis C Cardiac, gastrointestinal, or graft-versus-host disease (GVHD) History of or any concurrent condition, therapy, laboratory abnormality, or allergy to excipients that might confound the results of the study, interfere with the participant's ability to participate for the full duration of the study, or not be in the best interest of the participant to participate Must not be receiving any moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitor/inducers Any commercially available or investigational antileukemic therapy other than SNDX-5613 except for short-term administration of corticosteroids and/or hydroxyurea for cytoreduction Participation in another therapeutic interventional clinical study in which an investigational agent was administered within 30 days before starting SNDX-5613 Any concurrent systemic treatment to prevent GVHD

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Syndax Pharmaceuticals

Phone

781-419-1400

clinicaltrials@syndax.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nicole McNeer, MD, PhD

Organizational Affiliation

Syndax Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Umita Shrestha

UShrestha@mdanderson.org

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Study of Radiolabeled SNDX-5613 in Adults With Acute Leukemia

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