Talazoparib

Generic Name: Talazoparib

Brand Names: Talzenna

Drug Type: Small Molecule

Chemical Formula: C_₁₉H_₁₄F_₂N_₆O

CAS Number: 1207456-01-6

Unique Ingredient Identifier: 9QHX048FRV

Background: Talazoparib is an inhibitor of mammalian polyadenosine 5’-diphosphoribose polymerases (PARPs), enzymes responsible for regulating essential cellular functions, such as DNA transcription and DNA repair.
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Indication: Talazoparib is indicated for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2-negative locally advanced or metastatic breast cancer. This indication is approved by the FDA, EMA, and Health Canada.
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Associated Conditions: HRR gene-mutated (HRRm) metastatic castration-resistant prostate cancer (mCRPC), Metastatic Breast Cancer, Locally Advanced Breast Cancer (LABC)

Associated Therapies: -

Clinical Trials

Study of ASTX727 Plus Talazoparib in Patients With Triple Negative or Hormone Resistant/HER2-negative Metastatic Breast Cancer

Phase 1

Completed

Conditions: Metastatic Breast Cancer
Hormone Receptor Positive Tumor
Triple Negative Breast Cancer

Interventions: Drug: Talazoparib
Drug: ASTX727

First Posted Date: 2019-10-22

Last Posted Date: 2024-03-22

Lead Sponsor: Kathy Miller

Target Recruit Count: 34

Registration Number: NCT04134884

Locations: 🇺🇸
Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem, North Carolina, United States
🇺🇸
Indiana University Melvin & Bren Simon Cancer Center, Indianapolis, Indiana, United States

Talazoparib and Avelumab in Participants With Metastatic Renal Cell Carcinoma

Phase 2

Completed

Conditions: Metastatic Renal Cell Carcinoma
Succinate Dehydrogenase Deficient Renal Cell Carcinoma
Fumarate Hydratase Deficient Renal Cell Carcinoma

Interventions: Drug: Talazoparib
Drug: Avelumab

First Posted Date: 2019-08-28

Last Posted Date: 2023-12-11

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 19

Registration Number: NCT04068831

Locations: 🇺🇸
Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown, New Jersey, United States

and more 4 locations

Avelumab With Bempegaldesleukin With or Without Talazoparib or Enzalutamide in Advanced or Metastatic Solid Tumors

Phase 1

Terminated

Conditions: Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Metastatic Castration Resistant Prostate Cancer (mCRPC)

Interventions: Drug: avelumab
Drug: Bempegaldesleukin
Drug: talazoparib
Drug: enzalutamide

First Posted Date: 2019-08-09

Last Posted Date: 2021-10-14

Lead Sponsor: Pfizer

Target Recruit Count: 3

Registration Number: NCT04052204

Locations: 🇺🇸
University of Rochester Medical Center, Rochester, New York, United States
🇪🇸
Hospital Universitari Vall d'Hebron, Barcelona, Spain
🇧🇪
GZA Ziekenhuizen campus Sint-Augustinus, Wilrijk, Antwerpen, Belgium

and more 2 locations

Study to Evaluate Sacituzumab Govitecan in Combination With Talazoparib in Patients With Metastatic Breast Cancer.

Phase 1

Recruiting

Conditions: Breast Cancer

Interventions: Drug: Talazoparib
Drug: Sacituzumab Govitecan

First Posted Date: 2019-07-31

Last Posted Date: 2024-04-01

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 75

Registration Number: NCT04039230

Locations: 🇺🇸
Boston Medical Center, Boston, Massachusetts, United States
🇺🇸
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States

A Study of the Drugs Talazoparib and Temozolomide in Prostate Cancer

Phase 1

Active, not recruiting

Conditions: Prostate Cancer
Castration-resistant Prostate Cancer
Prostate Neoplasm
Prostate Adenocarcinoma
Prostate Cancer Metastatic

Interventions: Drug: Talazoparib
Drug: Temozolomide

First Posted Date: 2019-07-15

Last Posted Date: 2024-10-16

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 16

Registration Number: NCT04019327

Locations: 🇺🇸
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States
🇺🇸
University of Virginia, Charlottesville, Virginia, United States

and more 6 locations

Evaluation of Talazoparib, a PARP Inhibitor, in Patients With Somatic BRCA Mutant Metastatic Breast Cancer: Genotyping Based Clinical Trial

Phase 2

Recruiting

Conditions: Breast Cancer

Interventions: Drug: Talazoparib

First Posted Date: 2019-06-19

Last Posted Date: 2024-07-23

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 30

Registration Number: NCT03990896

Locations: 🇺🇸
Emory University Winship Cancer Institute, Atlanta, Georgia, United States
🇺🇸
Northwestern University, Chicago, Illinois, United States
🇺🇸
MD Anderson Cancer Center, Houston, Texas, United States

and more 4 locations

Talazoparib for Cohesin-Mutated AML and MDS With Excess Blasts

Phase 1

Recruiting

Conditions: Leukemia

Interventions: Drug: Talazoparib
Drug: Decitabine

First Posted Date: 2019-06-04

Last Posted Date: 2024-07-03

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 12

Registration Number: NCT03974217

Locations: 🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

Talazoparib and Radiation Therapy in Treating Patients With Locally Recurrent Gynecologic Cancers

Phase 1

Recruiting

Conditions: Recurrent Fallopian Tube Carcinoma
Recurrent Ovarian Carcinoma
Recurrent Primary Peritoneal Carcinoma
Recurrent Vaginal Carcinoma
Stage IV Cervical Cancer AJCC v8
Stage IV Fallopian Tube Cancer AJCC v8
Stage IVB Ovarian Cancer AJCC v8
Recurrent Cervical Carcinoma
Stage IV Uterine Corpus Cancer AJCC v8
Stage IVA Vaginal Cancer AJCC v8

Interventions: Other: Quality-of-Life Assessment
Radiation: Radiation Therapy
Drug: Talazoparib

First Posted Date: 2019-05-30

Last Posted Date: 2024-08-26

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 24

Registration Number: NCT03968406

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States
🇺🇸
Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States

TALAVE: Induction Talazoparib Followed by Combination of Talazoparib and Avelumab in Advanced Breast Cancer

Phase 1

Active, not recruiting

Conditions: Breast Cancer

Interventions: Drug: Talazoparib
Drug: Avelumab

First Posted Date: 2019-05-28

Last Posted Date: 2024-04-24

Lead Sponsor: Georgetown University

Target Recruit Count: 24

Registration Number: NCT03964532

Locations: 🇺🇸
University of Utah, Huntsman Cancer Institute, Salt Lake City, Utah, United States
🇺🇸
MedStar Georgetown University Hospital, Washington, District of Columbia, United States

Gedatolisib Plus Talazoparib in Advanced Triple Negative or BRCA1/2 Positive, HER2 Negative Breast Cancers

Phase 1

Active, not recruiting

Conditions: TNBC - Triple-Negative Breast Cancer

Interventions: Drug: Gedatolisib
Drug: Talazoparib

First Posted Date: 2019-04-11

Last Posted Date: 2024-06-07

Lead Sponsor: Kari Wisinski

Target Recruit Count: 37

Registration Number: NCT03911973

Locations: 🇺🇸
University of Illinois Cancer Center, Chicago, Illinois, United States
🇺🇸
Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States
🇺🇸
University of Iowa Hospital and Clinics, Iowa City, Iowa, United States

and more 2 locations

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