Tamibarotene

DRUG11 trials

Sponsors

CytRx, Northwestern University, Osaka City University, Kinki University, St. Marianna University School of Medicine

Conditions

Acute Myeloid LeukemiaAcute Promyelocytic LeukemiaAlzheimer's DiseaseAutosomal Dominant Polycystic Kidney Disease (ADPKD)Chronic Myelomonocytic LeukemiaHTLV-I-Associated MyelopathyLupus NephritisMyelodysplastic Syndrome

Phase 1

Tamibarotene and Arsenic Trioxide for Relapsed Acute Promyelocytic Leukemia

TerminatedNCT00985530

Northwestern UniversityAcute Promyelocytic Leukemia

Start: 2009-10-31End: 2011-05-31Updated: 2013-10-30

Phase I/II Study of SY-1425 (Tamibarotene) in Combination With Azacitidine and Venetoclax for Patients With Chronic Myelomonocytic Leukemia

WithdrawnNCT06085638

M.D. Anderson Cancer CenterChronic Myelomonocytic Leukemia

Start: 2023-09-14End: 2023-10-20Updated: 2024-03-07

Phase 2

Safety, Efficacy, & Pharmacokinetic Study of Tamibarotene to Treat Patients With Relapsed or Refractory APL

CompletedNCT00520208

CytRxAcute Promyelocytic Leukemia

Start: 2007-09-30End: 2013-01-31Updated: 2013-02-13

Efficacy and Safety of Tamibarotene (OAM80) for Alzheimer's Disease

Osaka City UniversityAlzheimer's Disease

Start: 2010-05-31End: 2012-12-31Target: 50Updated: 2011-07-22

Efficacy and Safety of Tamibarotene(AM80) for Lupus Nephritis

Kinki UniversityLupus Nephritis

Start: 2010-09-30End: 2013-02-28Target: 20Updated: 2011-07-22

First Line Study of Tamibarotene in Combination for Advanced Non-Small Cell Lung Cancer

TerminatedNCT01337154

CytRxStage IIIB Non-small Cell Lung Cancer With Pleural Effusion, Stage IV Non-small Cell Lung Cancer

Start: 2011-04-30End: 2013-06-30Updated: 2013-06-28

Efficacy and Safety of Tamibarotene(AM80H) for HTLV-1 Associated Myelopathy/ Tropical Spastic Paraparesis (HAM/TSP)

St. Marianna University School of MedicineHTLV-I-Associated Myelopathy

Start: 2011-01-31End: 2012-03-31Target: 15Updated: 2011-07-22

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

CompletedNCT02807558

Syros PharmaceuticalsAcute Myeloid Leukemia, Myelodysplastic Syndrome

Start: 2016-09-20End: 2023-01-25Updated: 2024-12-13

Tamibarotene Plus Venetoclax/Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)

TerminatedNCT04905407

Syros PharmaceuticalsAcute Myeloid Leukemia

Start: 2021-08-26End: 2024-08-12Updated: 2025-02-24

Study of Tamibarotene in Patients With ADPKD

Active, not recruitingNCT06289998

Rege Nephro Co., Ltd.Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Start: 2023-12-22End: 2025-12-31Target: 70Updated: 2025-04-04

Phase 3

Tamibarotene Plus Azacitidine in Participants With Newly Diagnosed RARA-positive Higher-Risk Myelodysplastic Syndrome

TerminatedNCT04797780

Syros PharmaceuticalsMyelodysplastic Syndromes

Start: 2021-02-08End: 2024-11-13Updated: 2025-04-10

Related Papers

Pivotal results of SELECT-MDS-1 phase 3 study of tamibarotene with azacitidine in newly diagnosed higher-risk MDS

Blood Advances2025-05-073 citations

Use of tamibarotene, a potent and selective RARα agonist, in combination with azacitidine in patients with relapsed and refractory AML with <i>RARA</i> gene overexpression

Leukemia & lymphoma/Leukemia and lymphoma2023-08-129 citations

PB1773: AML AND MDS WITH RARA OVEREXPRESSION: MOLECULAR AND CLINICAL FEATURES OF PATIENTS ENROLLED IN A PHASE 2 TRIAL EVALUATING TAMIBAROTENE-BASED THERAPY

HemaSphere2023-08-01

Targeting <i>RARA</i> overexpression with tamibarotene, a potent and selective RARα agonist, is a novel approach in AML

Blood Advances2022-12-0733 citations

Initial Results from SELECT-AML-1, a Phase 2 Study of Tamibarotene in Combination with Venetoclax and Azacitidine in RARA-Positive Newly Diagnosed AML Patients Ineligible for Standard Induction Chemotherapy

Blood2022-11-152 citations

A randomized, double-blind, placebo-controlled study of tamibarotene/azacitidine versus placebo/azacitidine in newly diagnosed adult patients selected for RARA+ HR-MDS (SELECT-MDS-1).

Journal of Clinical Oncology2022-06-014 citations

P492: TAMIBAROTENE IN COMBINATION WITH VENETOCLAX AND AZACITIDINE IN PREVIOUSLY UNTREATED ADULT PATIENTS SELECTED FOR RARA-POSITIVE AML WHO ARE INELIGIBLE FOR STANDARD INDUCTION THERAPY (SELECT AML-1)

HemaSphere2022-06-01

PB1921: A RANDOMIZED, DOUBLE-BLIND, PHASE 3 STUDY OF TAMIBAROTENE/AZACITIDINE VERSUS PLACEBO/AZACITIDINE IN NEWLY DIAGNOSED ADULT PATIENTS SELECTED FOR RARA-POSITIVE HR-MDS (SELECT-MDS-1)

HemaSphere2022-06-01

Tamibarotene in combination with venetoclax and azacitidine in previously untreated adult patients selected for RARA-positive AML who are ineligible for standard induction therapy (SELECT AML-1).

Journal of Clinical Oncology2022-06-01

SY-1425, a Potent and Selective RARα Agonist, in Combination with Azacitidine Demonstrates a High Complete Response Rate and a Rapid Onset of Response in RARA-Positive Newly Diagnosed Unfit Acute Myeloid Leukemia

Blood2020-11-0410 citations

Initial Results from a Biomarker-Directed Phase 2 Trial of SY-1425, a Potent and Selective RARα Agonist, in Combination with Azacitidine in Relapsed/Refractory Acute Myeloid Leukemia

Blood2020-11-043 citations

Selection of RARA-Positive Newly Diagnosed Unfit AML Patients with Elevated RARA Gene Expression Enriches for Features Associated with Primary Resistance to Venetoclax and Clinical Response to SY-1425, a Potent and Selective RARα Agonist, Plus Azacitidine

Blood2020-11-042 citations

Early Results from a Biomarker-Directed Phase 2 Trial of Sy-1425 in Combination with Azacitidine or Daratumumab in Non-APL Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)

Blood2018-11-296 citations

Abstract PR05: SY-1425 (tamibarotene), a potent and selective RARα agonist, induces changes in the transcriptional regulatory circuit of AML cells leading to differentiation

Clinical Cancer Research2017-12-14

Early Results from a Biomarker-Directed Phase 2 Trial of Sy-1425 in Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Demonstrate DHRS3 Induction and Myeloid Differentiation Following Sy-1425 Treatment

Blood2017-12-0710 citations

Abstract 1511: AML patient clustering by super-enhancers reveals an RARA associated transcription factor signaling partner

Cancer Research2017-07-01

Abstract 3085: SY-1425 (tamibarotene), a selective RARα agonist, shows synergistic anti-tumor activity with hypomethylating agents in a biomarker selected subset of AML

Cancer Research2017-07-01

A biomarker-directed phase 2 trial of SY-1425, a selective retinoic acid receptor alpha agonist, in adult patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).

Journal of Clinical Oncology2017-05-20

SY1425 (tamibarotene) Induces Profound Transcriptional Changes in AML Tumors with High Retinoic Acid Receptor Alpha

Blood2016-12-021 citations

Clinical Pharmacodynamic Markers and Combinations with SY1425 (tamibarotene) in a Genomically-Defined Subset of Non-APL AML

Blood2016-12-02

2 more papers not shown