Talazoparib

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Information
Drug Name
Talazoparib
Description
Entry(CIViC)
5
CIViC
Disease Mutation EL ET ED CS VO TR Pubmed Links
breast cancer BRCA1 LOSS-OF-FUNCTION BRCA1 LOSS-OF-FUNCTION B Predictive Supports Sensitivity/Response Rare Germline 4 28242752 Detail
breast cancer BRCA2 LOSS-OF-FUNCTION BRCA2 LOSS-OF-FUNCTION B Predictive Supports Sensitivity/Response Rare Germline 4 28242752 Detail
ovarian cancer BRCA2 LOSS-OF-FUNCTION BRCA2 LOSS-OF-FUNCTION B Predictive Supports Sensitivity/Response Rare Germline 3 28242752 Detail
ovarian cancer BRCA1 LOSS-OF-FUNCTION BRCA1 LOSS-OF-FUNCTION B Predictive Supports Sensitivity/Response Rare Germline 3 28242752 Detail
endometrial cancer MRE11 LOSS
( ENST00000323929.8 ) MRE11 LOSS
( ENST00000323929.8 ) 		D Predictive Supports Sensitivity/Response N/A 2 24927325 Detail
Annotation
Description Associated Genes Associated Variants Sensitivity Supported Source Links
In part 2 of a two-part dose-escalation phase I tr... BRCA1 BRCA1 LOSS-OF-FUNCTION BRCA1 LOSS-OF-FUNCTION Sensitivity true CIViC Evidence detail
In part 2 of a two-part dose-escalation phase I tr... BRCA2 BRCA2 LOSS-OF-FUNCTION BRCA2 LOSS-OF-FUNCTION Sensitivity true CIViC Evidence detail
In part 2 of a two-part dose-escalation phase I tr... BRCA2 BRCA2 LOSS-OF-FUNCTION BRCA2 LOSS-OF-FUNCTION Sensitivity true CIViC Evidence detail
In part 2 of a two-part dose-escalation phase I tr... BRCA1 BRCA1 LOSS-OF-FUNCTION BRCA1 LOSS-OF-FUNCTION Sensitivity true CIViC Evidence detail
One endometrial cell line with decreased MRE11 exp... MRE11 MRE11 LOSS
( ENST00000323929.8 ) MRE11 LOSS
( ENST00000323929.8 ) 		Sensitivity true CIViC Evidence detail
NCT ID Status Phase Summary Start date Completion date
NCT04591431 Active, not recruiting Phase 2 The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy October 7, 2020 June 2025
NCT04207190 Active, not recruiting Phase 1 Talazoparib and Gemtuzumab Ozogamicin for the Treatment of CD33 Positive Relapsed or Refractory Acute Myeloid Leukemia October 23, 2020 April 1, 2025
NCT04332744 Active, not recruiting Phase 2 Enzalutamide Plus Talazoparib for the Treatment of Hormone Sensitive Prostate Cancer (ZZ-First) September 2, 2020 July 31, 2025
NCT04334941 Active, not recruiting Phase 2 Testing Maintenance Therapy for Small Cell Lung Cancer in Patients With SLFN11 Positive Biomarker July 20, 2020 November 30, 2025
NCT04337970 Active, not recruiting Phase 1/Phase 2 Talazoparib and Axitinib for People With Previously Treated Advanced Kidney Cancer April 6, 2020 October 2024
NCT04173507 Active, not recruiting Phase 2 Combination Treatment (Talazoparib Plus Avelumab) for Stage IV or Recurrent Non-Squamous Non-Small Cell Lung Cancer With STK11 Gene Mutation (A LUNG-MAP Treatment Trial) February 14, 2020 July 1, 2024
NCT05097599 Active, not recruiting Phase 2 Strata PATH™ (Precision Indications for Approved Therapies) November 19, 2021 November 19, 2029
NCT02912572 Active, not recruiting Phase 2 Avelumab in Patients With MSS, MSI-H and POLE-mutated Recurrent or Persistent Endometrial Cancer and of Avelumab/Talazoparib and Avelumab/Axitinib in Patients With MSS Recurrent or Persistent Endometrial Cancer November 14, 2016 March 2027
NCT03343054 Active, not recruiting Phase 1 A Phase 1 Study Of Talazoparib, PARP Inhibitor, In Japanese Patients With Advanced Solid Tumors November 30, 2017 August 31, 2024
NCT05059522 Active, not recruiting Phase 3 Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing September 29, 2021 September 30, 2026
NCT04991480 Active, not recruiting Phase 1 A Study of ART4215 for the Treatment of Advanced or Metastatic Solid Tumors September 13, 2021 August 2025
NCT04901702 Active, not recruiting Phase 1/Phase 2 Study of Onivyde With Talazoparib or Temozolomide in Children With Recurrent Solid Tumors and Ewing Sarcoma June 9, 2021 December 31, 2025
NCT04846478 Active, not recruiting Phase 1 Phase Ia/Ib Talazoparib + Tazemetostat for mCRPC June 28, 2021 September 30, 2025
NCT03911973 Active, not recruiting Phase 1/Phase 2 Gedatolisib Plus Talazoparib in Advanced Triple Negative or BRCA1/2 Positive, HER2 Negative Breast Cancers April 17, 2019 July 2024
NCT03964532 Active, not recruiting Phase 1/Phase 2 TALAVE: Induction Talazoparib Followed by Combination of Talazoparib and Avelumab in Advanced Breast Cancer April 17, 2019 December 2024
NCT02286687 Active, not recruiting Phase 2 Talazoparib in Treating Patients With Recurrent, Refractory, Advanced, or Metastatic Cancers and Alterations in the BRCA Genes December 22, 2014 December 31, 2025
NCT04019327 Active, not recruiting Phase 1/Phase 2 A Study of the Drugs Talazoparib and Temozolomide in Prostate Cancer July 11, 2019 July 2027
NCT05650476 Available Pre-approval Single-patient Expanded Access for Talazoparib (PF-06944076)
NCT02997163 Completed Phase 1 An Open-Label Pharmacokinetics and Safety Study of Talazoparib February 21, 2017 January 30, 2019
NCT02997176 Completed Phase 1 An Open-Label Pharmacokinetics and Safety Study of Talazoparib (MDV3800) September 30, 2016 February 12, 2020
NCT03042910 Completed Phase 1 A Study to Assess the Effects of Talazoparib on Cardiac Repolarization in Patients With Advanced Solid Tumors October 13, 2016 June 22, 2017
NCT03070548 Completed Phase 1 A Study of Talazoparib in Patients With Advanced Solid Tumors September 2016 June 2017
NCT03077607 Completed Phase 1 A Study to Evaluate the Effect of Itraconazole and Rifampin on the Pharmacokinetics of Talazoparib in Patients With Advanced Solid Tumors November 7, 2016 January 20, 2018
NCT03148795 Completed Phase 2 A Study of Talazoparib in Men With DNA Repair Defects and Metastatic Castration-Resistant Prostate Cancer July 4, 2017 March 31, 2023
NCT04635631 Completed Phase 1 STUDY OF TALAZOPARIB MONOTHERAPY IN CHINESE PARTICIPANTS WITH ADVANCED SOLID TUMORS November 30, 2020 December 14, 2021
NCT03377556 Completed Phase 2 Lung-MAP: Talazoparib in Treating Patients With HRRD Positive Recurrent Stage IV Squamous Cell Lung Cancer March 3, 2017 April 16, 2021
NCT04187833 Completed Phase 2 Nivolumab in Combination With Talazoparib in Melanoma and Mutations in BRCA or BRCA-ness Genes June 5, 2020 October 13, 2023
NCT02154490 Completed Lung-MAP: Biomarker-Targeted Second-Line Therapy in Treating Patients With Recurrent Stage IV Squamous Cell Lung Cancer July 8, 2014 April 15, 2022
NCT02282345 Completed Phase 2 Talazoparib Before Standard Therapy in Treating Patients With Invasive, BRCA-Mutated Breast Cancer April 16, 2015 June 7, 2022
NCT04987931 Completed Real-World Outcomes of US Talazoparib-Treated Patients With Locally Advanced or Metastatic Breast Cancer August 20, 2021 October 11, 2021
NCT02116777 Completed Phase 1/Phase 2 Talazoparib and Temozolomide in Treating Younger Patients With Refractory or Recurrent Malignancies May 16, 2014 December 31, 2018
NCT02392793 Completed Phase 1 Talazoparib Plus Irinotecan With or Without Temozolomide in Children With Refractory or Recurrent Solid Malignancies March 25, 2015 August 30, 2019
NCT02921919 Completed Phase 2 Open-Label Extension and Safety Study of Talazoparib November 8, 2016 July 20, 2021
NCT02317874 Completed Phase 1 Testing the Addition of the Anti-Cancer Drug Talazoparib to the Combination of Carboplatin and Paclitaxel for the Treatment of Advanced Cancer September 8, 2015 May 3, 2022
NCT01286987 Completed Phase 1 Study of Talazoparib, a PARP Inhibitor, in Patients With Advanced or Recurrent Solid Tumors January 3, 2011 January 30, 2017
NCT04068831 Completed Phase 2 Talazoparib and Avelumab in Participants With Metastatic Renal Cell Carcinoma August 22, 2019 December 6, 2023
NCT05141708 Completed Treatment Patterns and Clinical Outcomes Among Talazoparib-Treated Adults With HER2-Negative mBC With gBRCA1/2m December 17, 2021 June 30, 2022
NCT01945775 Completed Phase 3 A Study Evaluating Talazoparib (BMN 673), a PARP Inhibitor, in Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (EMBRACA Study) October 14, 2013 March 5, 2021
NCT04134884 Completed Phase 1 Study of ASTX727 Plus Talazoparib in Patients With Triple Negative or Hormone Resistant/HER2-negative Metastatic Breast Cancer April 1, 2020 March 14, 2024
NCT02878785 Completed Phase 1/Phase 2 Decitabine and Talazoparib in Untreated AML and R/R AML August 2016 November 19, 2020
NCT05873192 Not yet recruiting Phase 2 Presurgical Phase II Study of Talazoparib in Combination With Enzalutamide in Prostate Cancer September 30, 2024 December 31, 2028
NCT04462809 Not yet recruiting Phase 2 Efficacy of a Maintenance Treatment With TALAzoparib Following First Line Platinum-based Chemotherapy in Malignant MESOthelioma September 1, 2020 October 1, 2024
NCT06218628 Recruiting Phase 1 Pacritinib w/ Talazoparib in Pts w/ Myeloproliferative Neoplasms Unresponsive to JAK2 Inhibition April 5, 2024 August 27, 2030
NCT02693535 Recruiting Phase 2 TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer March 14, 2016 December 31, 2025
NCT02925234 Recruiting Phase 2 The Drug Rediscovery Protocol (DRUP Trial) August 2016 December 2027
NCT03672773 Recruiting Phase 2 Talazoparib and Low-Dose Temozolomide in Treating Participants With Relapsed or Refractory Extensive-Stage Small Cell Lung Cancer October 31, 2018 October 1, 2025
NCT03968406 Recruiting Phase 1 Talazoparib and Radiation Therapy in Treating Patients With Locally Recurrent Gynecologic Cancers September 26, 2019 October 1, 2024
NCT03974217 Recruiting Phase 1 Talazoparib for Cohesin-Mutated AML and MDS With Excess Blasts August 1, 2019 June 1, 2025
NCT03990896 Recruiting Phase 2 Evaluation of Talazoparib, a PARP Inhibitor, in Patients With Somatic BRCA Mutant Metastatic Breast Cancer: Genotyping Based Clinical Trial November 18, 2021 December 31, 2025
NCT04039230 Recruiting Phase 1/Phase 2 Study to Evaluate Sacituzumab Govitecan in Combination With Talazoparib in Patients With Metastatic Breast Cancer. October 9, 2019 December 2026
NCT04486352 Recruiting Phase 1/Phase 2 A Study of Targeted Agents for Patients With Recurrent or Persistent Endometrial Cancer October 20, 2021 October 2026
NCT04497116 Recruiting Phase 1/Phase 2 Study of RP-3500, Camonsertib, in Advanced Solid Tumors July 22, 2020 December 31, 2025
NCT04550494 Recruiting Phase 2 Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations April 26, 2021 December 1, 2024
NCT04703920 Recruiting Phase 1 Talazoparib in Combination With Belinostat for Metastatic Breast Cancer, Metastatic Castration Resistant Prostate Cancer, and Metastatic Ovarian Cancer March 4, 2021 July 2024
NCT04734730 Recruiting Phase 2 Talazoparib With Androgen Deprivation Therapy and Abiraterone for the Treatment of Castration Sensitive Prostate Cancer May 4, 2021 August 23, 2027
NCT04849364 Recruiting Phase 2 Circulating Tumor DNA Enriched, Genomically Directed Post-neoadjuvant Trial for Patients With Residual Triple Negative Breast Cancer August 24, 2021 January 31, 2034
NCT05035745 Recruiting Phase 1/Phase 2 Selinexor & Talazoparib in Advanced Refractory Solid Tumors; Advanced/Metastatic Triple Negative Breast Cancer (START) March 1, 2021 November 2025
NCT05053854 Recruiting Phase 1 PARP Inhibitor With 177Lu-DOTA-Octreotate PRRT in Patients With Neuroendocrine Tumours December 8, 2021 December 31, 2025
NCT05071937 Recruiting Phase 2 ZEN003694 Combined With Talazoparib in Patients With Recurrent Ovarian Cancer April 13, 2023 March 1, 2031
NCT05101551 Recruiting Phase 1 Study of Talazoparib in Combination With Chemotherapy in Relapsed Pediatric AML to Determine Safety and Efficacy February 23, 2023 March 2026
NCT05142241 Recruiting Phase 2 Testing the Combination of Anti-Cancer Drugs Talazoparib and Temozolomide in Patients With Advanced Stage Rare Cancers, RARE 2 Trial July 11, 2022 April 15, 2026
NCT05288127 Recruiting Phase 2 Efficacy of Talazoparib in Asian Metastatic Breast Cancer Patients With a Homologous Recombinant Deficiency (HRD) Signature March 8, 2022 November 2025
NCT05327010 Recruiting Phase 2 Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial November 14, 2022 August 4, 2025
NCT05725200 Recruiting Phase 2 Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer September 27, 2022 December 31, 2040
NCT06193525 Recruiting Phase 2 FUnctional Selection of Advanced Breast Cancer Patients for Talazoparib Treatment Using the REpair Capacity (RECAP) Test September 16, 2019 December 2025
NCT05425862 Suspended Phase 1 Pidnarulex and Talazoparib in Patients With Metastatic Castration Resistant Prostate Cancer October 21, 2022 December 30, 2025
NCT02034916 Terminated Phase 2 A Phase 2, 2-Stage, 2-Cohort Study of Talazoparib (BMN 673), in Locally Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (ABRAZO Study) December 13, 2013 October 31, 2018
NCT03499353 Terminated Phase 2 Talazoparib For Neoadjuvant Treatment Of Germline BRCA1/2 Mutation Patients With Early Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer August 27, 2018 September 23, 2020
NCT03637491 Terminated Phase 1/Phase 2 A Study of Avelumab, Binimetinib and Talazoparib in Patients With Locally Advanced or Metastatic RAS-mutant Solid Tumors August 15, 2018 February 2, 2021
NCT04052204 Terminated Phase 1/Phase 2 Avelumab With Bempegaldesleukin With or Without Talazoparib or Enzalutamide in Advanced or Metastatic Solid Tumors December 30, 2019 September 29, 2020
NCT04690855 Terminated Phase 2 A Study to Evaluate TAlazoparib, Radiotherapy and Atezolizumab in gBRCA 1/2 Negative Patients With PD-L1+ Metastatic Triple Negative Breast Cancer October 4, 2021 December 20, 2022
NCT04801966 Terminated N/A Safety and Oversight of the Individually Tailored Treatment Approach: A Novel Pilot Study September 23, 2021 December 30, 2022
NCT03901469 Terminated Phase 2 A Study of ZEN003694 and Talazoparib in Patients With Triple Negative Breast Cancer June 26, 2019 March 7, 2024
NCT03875313 Terminated Phase 1/Phase 2 Study of CB-839 (Telaglenastat) in Combination With Talazoparib in Patients With Solid Tumors May 20, 2019 July 29, 2020
NCT03565991 Terminated Phase 2 Javelin BRCA/ATM: Avelumab Plus Talazoparib in Patients With BRCA or ATM Mutant Solid Tumors June 18, 2018 February 3, 2023
NCT04824937 Unknown status Phase 2 Telaglenastat + Talazoparib In Prostate Cancer July 2021 December 31, 2021
NCT04755868 Unknown status Phase 2 Talazoparib Maintenance Therapy in Triple-negative Breast Cancer March 2021 March 1, 2024
NCT04740190 Unknown status Phase 2 Talazoparib - Carboplatin for Recurrent High-grade Glioma With DDRd January 1, 2021 December 31, 2023
NCT02567396 Withdrawn Phase 1 Talazoparib in Treating Patients With Advanced or Metastatic Solid Tumors That Cannot Be Removed by Surgery and Liver or Kidney Dysfunction June 2016
NCT02836028 Withdrawn Phase 2 A Study Evaluating Talazoparib in Relapsed Ovarian, Fallopian Tube, and Peritoneal Cancer October 2016
NCT02537561 Withdrawn Phase 1 Talazoparib in Combination With Gemcitabine and Cisplatin in Patients With Advanced Solid Tumors December 2015 December 2018
NCT02627430 Withdrawn Phase 1 Talazoparib and HSP90 Inhibitor AT13387 in Treating Patients With Metastatic Advanced Solid Tumor or Recurrent Ovarian, Fallopian Tube, Primary Peritoneal, or Triple Negative Breast Cancer March 2016