A Study for Oral SY-2101 for Participants With Acute Promyelocytic Leukemia

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Brief Title

A Study for Oral SY-2101 for Participants With Acute Promyelocytic Leukemia

Official Title

An Open-label Phase 1 Study to Evaluate Pharmacokinetics, Safety, and Tolerability of SY-2101 in Adult Patients With Acute Promyelocytic Leukemia

Brief Summary

      SY-2101 is being studied as a treatment for participants with a type of leukemia called acute
      promyelocytic leukemia (APL). SY-2101 is an oral form of a drug called arsenic trioxide
      (ATO). ATO is already used to treat APL in a form that is given as an intravenous (IV)
      infusion (through a needle in the arm). SY-2101 is a different form of ATO that is taken
      orally (by mouth).

      This trial will include participants with low-risk APL in remission, who are receiving
      standard of care treatment with all-trans-retinoic acid (ATRA) and intravenous ATO, during
      the consolidation phase of chemotherapy with low-risk APL. The participants in this trial
      will get continued treatment with ATO and ATRA to help keep their cancer from coming back.
      There will be some weeks when participants receive intravenous ATO and others when they
      receive SY-2101 (ATO taken orally).
    

Detailed Description

      This study includes 3 parts: during one part, enrolled participants will receive a single
      dose of IV ATO, and a week later a single dose of SY-2101 either in the fed or fasted
      condition, and a week after that, a single dose of SY-2101 in the fed or fasted condition.
      After each of these doses, blood draws and safety assessments will be performed. In another
      part of the study, enrolled participants will receive IV ATO according to the standard of
      care, with collection of blood and safety assessments. In the third part of the study,
      enrolled participants who are documented to be in molecular remission will receive SY-2101 in
      place of IV ATO during the 4th cycle of consolidation, with the collection of blood and
      safety assessments throughout the cycle. Participants do not need to participate in all parts
      of the study to enroll.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Single-Dose Module: Maximum Observed Plasma Concentration (Cmax) of SY-2101

Secondary Outcome

 Single-Dose Module: Cmax of ATO

Condition

Acute Promyelocytic Leukemia

Intervention

SY-2101

Study Arms / Comparison Groups

 Single-Dose PK Module: Sequence 1
Description:  Participants will receive ATO as IV infusion in fasted state on Day 1, SY-2101 administered orally in fed state on Day 8, and SY-2101 administered orally in fasted state on Day 15 during Weeks 6, 7, and 8 of any consolidation cycle being received as part of SOC treatment consolidation cycle

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

24

Start Date

September 17, 2021

Completion Date

March 2023

Primary Completion Date

March 2023

Eligibility Criteria

        Inclusion Criteria:

          -  Participants must have a diagnosis of low risk APL characterized by the presence of
             the t(15;17) translocation or PML/RARA gene expression via reverse transcription
             polymerase chain reaction (RT-PCR), fluorescence in situ hybridization (FISH), or
             cytogenetics.

          -  Participants must have received ATO plus ATRA induction therapy and must have received
             or are eligible and planning to receive consolidation therapy with ATO plus ATRA in
             alignment with National Comprehensive Cancer Network (NCCN) guidelines for low-risk
             APL prior to their enrollment in the study.

          -  Participants must be able to tolerate full dose ATO per NCCN guidelines.

          -  Participants must be in morphological complete remission (CR) at the end of induction.

          -  Participants must have a serum/urine pregnancy test (for females of childbearing
             potential) that is negative at the Screening Visit and immediately prior to initiation
             of study treatment (first dose of study drug).

        Exclusion Criteria:

          -  Participants who have demonstrated relapse and therefore are not eligible for further
             consolidation.

          -  Participants currently receiving treatment for a non-APL malignancy (not including
             basal cell carcinoma, non-melanoma skin cancer, cervical carcinoma in situ, or
             localized prostate cancer treated with hormone therapy). Participants with history of
             other cancers should be free of disease for at least 2 years prior to the Screening
             Visit.

          -  Participants with an active, life-threatening, or clinically-significant uncontrolled
             systemic infection requiring hospitalization.

          -  Immunocompromised participants with increased risk of opportunistic infections,
             including known human immunodeficiency virus (HIV)-positive participants with cluster
             of differentiation 4 (CD4) counts ≤350 cells/millimeters (mm^3) or history of
             opportunistic infection in the last 12 months.

          -  Participants with a known active or chronic hepatitis B or active hepatitis C virus
             (HCV) infection. Participants with a history of HCV infection who have completed
             curative therapy for HCV at least 12 weeks before the Screening Visit and have a
             documented undetectable viral load at the Screening Visit are eligible for enrollment.

          -  Participants who have not adequately recovered from a major surgery within 4 weeks of
             starting study drug administration.

          -  Participants who received any other investigational agents within 4 weeks of the
             Screening Visit or <5 half-lives since completion of previous investigational therapy
             have elapsed, whichever is shorter.

          -  Participants who have a hypersensitivity to arsenic.

          -  Participants who have experienced the following Grade ≥3 non-hematologic toxicities
             associated with ATO administration: QT prolongation, hepatotoxicity, neurotoxicity,
             cardiac function abnormalities. Participants who experienced other severe and
             life-threatening clinically-significant ATO-related AEs that are considered, in the
             judgement of the investigator, to increase participant risk with continued ATO
             treatment are also excluded.

        Other inclusion/exclusion criteria may apply.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Medical Director, MD, (617) 744-1340, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04996030

Organization ID

SY-2101-101


Responsible Party

Sponsor

Study Sponsor

Syros Pharmaceuticals


Study Sponsor

Medical Director, MD, Study Director, Syros Pharmaceuticals


Verification Date

September 2021