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A Biomarker-Directed Phase 2 Trial of Tamibarotene (SY-1425) in Participants With Acute Myeloid Leukemia or Myelodysplastic Syndrome

NCT02807558 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 155

Last updated 2024-12-13

Study results available
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Summary

The purpose of this study is to determine the activity of tamibarotene in participants with relapsed/refractory (R/R) AML (administered as a monotherapy or in combination with azacitidine), R/R higher-risk MDS (HR-MDS) (administered as a monotherapy or in combination with daratumumab), newly diagnosed treatment naïve AML participants who are unlikely to tolerate standard intensive chemotherapy (administered as a monotherapy or in combination with azacitidine), or lower-risk MDS (LR-MDS) (administered as a monotherapy).

Conditions

Interventions

DRUG

Tamibarotene

Administered as oral tablets

DRUG

Azacitidine

Administered via intravenous (IV) or subcutaneous (SC) infusion

DRUG

Daratumumab

Administered via IV infusion

Sponsors & Collaborators

  • Syros Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Medical Director · Syros Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-20
Primary Completion
2023-01-25
Completion
2023-01-25
FDA Drug
Yes

Countries

  • United States
  • France

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02807558 on ClinicalTrials.gov