DeepMed Research

Birinapant

Generic Name: Birinapant

Drug Type: Small Molecule

Chemical Formula: C_₄₂H_₅₆F_₂N_₈O_₆

CAS Number: 1260251-31-7

Unique Ingredient Identifier: 6O4Z07B57R

Background: Birinapant has been investigated for the treatment of Myelodysplastic Syndrome (MDS) and Chronic Myelomonocytic Leukemia (CMML).

Clinical Trials

Phase 1a/1b Study of Aplitabart (IGM-8444) Alone or in Combination in Participants with Relapsed, Refractory, or Newly Diagnosed Cancers

Phase 1

Terminated

Conditions: Acute Myeloid Leukemia
Sarcoma
Chondrosarcoma
Chronic Lymphocytic Leukemia
Colorectal Cancer
Solid Tumor
Non Hodgkin Lymphoma
Small Lymphocytic Lymphoma

Interventions: Drug: Aplitabart (IGM-8444)
Drug: FOLFIRI
Drug: Birinapant
Drug: Gemcitabine
Drug: Venetoclax
Drug: Azacitidine
Drug: Bevacizumab (and approved biosimilars)
Drug: Docetaxel

First Posted Date: 2020-09-17

Last Posted Date: 2025-03-28

Lead Sponsor: IGM Biosciences, Inc.

Target Recruit Count: 272

Registration Number: NCT04553692

Locations: 🇺🇸
Mayo Clinic, Minneapolis, Minnesota, United States
🇺🇸
Minnesota Oncology - Minneapolis Clinic, Minneapolis, Minnesota, United States
🇺🇸
UCSF, San Francisco, California, United States

and more 53 locations

Birinapant and Intensity Modulated Re-Irradiation Therapy in Treating Patients With Locally Recurrent Head and Neck Squamous Cell Carcinoma

Phase 1

Active, not recruiting

Conditions: Locally Recurrent Head and Neck Squamous Cell Carcinoma
Nasopharyngeal Squamous Cell Carcinoma
Sinonasal Squamous Cell Carcinoma

Interventions: Procedure: Biopsy Procedure
Drug: Birinapant
Procedure: Computed Tomography
Radiation: Intensity-Modulated Radiation Therapy
Procedure: Magnetic Resonance Imaging
Procedure: Positron Emission Tomography

First Posted Date: 2019-01-15

Last Posted Date: 2025-05-15

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 13

Registration Number: NCT03803774

Locations: 🇺🇸
HaysMed, Hays, Kansas, United States
🇺🇸
The University of Kansas Cancer Center - Olathe, Olathe, Kansas, United States
🇺🇸
Mercy Hospital Pittsburg, Pittsburg, Kansas, United States

and more 30 locations

Birinapant and Carboplatin in Treating Patients and Targeting Recurrent High Grade Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (HGSOC)

Phase 1

Withdrawn

Conditions: High Grade Fallopian Tube Serous Adenocarcinoma
Primary Peritoneal High Grade Serous Adenocarcinoma
Recurrent Primary Peritoneal Carcinoma
High Grade Ovarian Serous Adenocarcinoma
Recurrent Fallopian Tube Carcinoma
Recurrent Ovarian Carcinoma

Interventions: Drug: Birinapant
Drug: Carboplatin
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study

First Posted Date: 2016-04-29

Last Posted Date: 2025-05-13

Lead Sponsor: Jonsson Comprehensive Cancer Center

Registration Number: NCT02756130

Locations: 🇺🇸
UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California, United States

Dose-escalation Study of Birinapant and Pembrolizumab in Solid Tumors

Phase 1

Terminated

Conditions: Solid Tumors

Interventions: Drug: Birinapant
Drug: Pembrolizumab

First Posted Date: 2015-10-27

Last Posted Date: 2021-01-14

Lead Sponsor: Medivir

Target Recruit Count: 34

Registration Number: NCT02587962

Locations: 🇺🇸
Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
🇺🇸
The Sidney Kimmel Comprehensive Cancer Center at John Hopkins, Baltimore, Maryland, United States
🇺🇸
UCLA Dept of Medicine-Hematology/Oncology, Santa Monica, California, United States

and more 6 locations

Phase I Safety and Tolerability Study of Birinapant in Chronic Hepatitis B

Phase 1

Terminated

Conditions: Hepatitis B

Interventions: Drug: Antiviral Therapy (tenofovir or entecavir)
Drug: Placebo (for birinapant)
Drug: Birinapant

First Posted Date: 2014-11-11

Last Posted Date: 2016-02-05

Lead Sponsor: TetraLogic Pharmaceuticals

Target Recruit Count: 7

Registration Number: NCT02288208

Locations: 🇦🇺
Linear Clinical Research Ltd, Nedlands, Western Australia, Australia
🇦🇺
CMAX / Royal Adelaide Hospital, Adelaide, South Australia, Australia
🇦🇺
Nucleus Network Limited / AMREP Precinct, Melbourne, Victoria, Australia

Study of Azacitidine With or Without Birinapant in Subjects With MDS or CMMoL

Phase 2

Terminated

Conditions: Myelodysplastic Syndrome (MDS)
Chronic Myelomonocytic Leukemia (CMML)

Interventions: Drug: birinapant
Drug: Azacitidine
Drug: Placebo

First Posted Date: 2014-05-28

Last Posted Date: 2016-10-20

Lead Sponsor: TetraLogic Pharmaceuticals

Target Recruit Count: 118

Registration Number: NCT02147873

Locations: 🇺🇸
University of Maryland, Greenebaum Cancer Center, Baltimore, Maryland, United States
🇺🇸
Desert Hematology Oncology Medical Group, Rancho Mirage, California, United States
🇺🇸
Gabrail Cancer Center Research, Canton, Ohio, United States

and more 72 locations

Study of Birinapant in Combination With Conatumumab in Subjects With Relapsed Ovarian Cancer

Phase 1

Completed

Conditions: Relapsed Epithelial Ovarian Cancer
Relapsed Fallopian Tube Cancer
Relapsed Primary Peritoneal Cancer

Interventions: Drug: Birinapant
Drug: Conatumumab

First Posted Date: 2013-09-12

Last Posted Date: 2016-01-14

Lead Sponsor: TetraLogic Pharmaceuticals

Target Recruit Count: 27

Registration Number: NCT01940172

Locations: 🇺🇸
TetraLogic research site, Fresno, California, United States
🇺🇸
TetraLogic Research Site, Nashville, Tennessee, United States
🇺🇸
TetraLogic Research Facility, Dallas, Texas, United States

Birinapant With 5-azacitidine in MDS Subjects Who Are Naïve, Have Relapsed or Are Refractory to 5-azacitidine Therapy

Phase 1

Completed

Conditions: Myelodysplastic Syndrome

Interventions: Drug: Birinapant
Drug: 5-Azacitidine

First Posted Date: 2013-04-10

Last Posted Date: 2016-04-21

Lead Sponsor: TetraLogic Pharmaceuticals

Target Recruit Count: 21

Registration Number: NCT01828346

Locations: 🇺🇸
The University of Texas M.D. Anderson Cancer Center, Houston, Texas, United States
🇺🇸
California Cancer Associates for Research and Excellence, Fresno, California, United States
🇺🇸
Mayo Clinic Scottsdale, Scottsdale, Arizona, United States

and more 4 locations

Birinapant for Advanced Ovarian, Fallopian Tube, and Peritoneal Cancer

Phase 2

Terminated

Conditions: Peritoneal Neoplasms
Fallopian Tube Neoplasms
Epithelial Ovarian Cancer

Interventions: Drug: Birinapant (TL32711)

First Posted Date: 2012-09-07

Last Posted Date: 2017-05-30

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 11

Registration Number: NCT01681368

Locations: 🇺🇸
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

A Phase I-II Open Label Non-Randomized Study Using TL32711 for Patients With Acute Myelogenous Leukemia, Myelodysplastic Syndrome and Acute Lymphoblastic Leukemia

Phase 1

Terminated

Conditions: Acute Myelogenous Leukemia

Interventions: Drug: Birinapant

First Posted Date: 2011-12-07

Last Posted Date: 2021-06-24

Lead Sponsor: Abramson Cancer Center at Penn Medicine

Target Recruit Count: 27

Registration Number: NCT01486784

Locations: 🇺🇸
Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, United States

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