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Saruparib

DRUG15 trials

Sponsors

AstraZeneca AB, Centre Leon Berard, OHSU Knight Cancer Institute, AstraZeneca, SWOG Cancer Research Network

Conditions

Advanced Breast CancerAdvanced Solid MalignanciesAdvanced Solid TumorsAdvanced/Recurrent Ovarian CancerAdvanced/Recurrent Ovarian cancerBorderline Resectable Pancreatic Ductal AdenocarcinomaExtensive Stage Lung Small Cell CarcinomaLocally Advanced Pancreatic Ductal Adenocarcinoma

Early Phase 1

Phase 1

A Multi-arm, Open-label Phase I/IIa Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of AZD5305 in Combination with New Hormonal Agents in Patients with Metastatic Prostate Cancer (PETRANHA)
Active, not recruitingCTIS2023-508536-64-00
AstraZeneca ABMetastatic Prostate Cancer
Start: 2022-05-17Target: 50Updated: 2025-04-28
A Modular Phase I/IIa, Open-label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Ascending Doses of AZD5305 as Monotherapy and in Combination with Anti-cancer Agents in Patients with Advanced Solid Malignancies (PETRA)
Active, not recruitingCTIS2022-502856-29-00
AstraZeneca ABAdvanced Solid Tumors
Start: 2021-07-27Target: 427Updated: 2025-11-10
Modular Clinical Pharmacology Study to Evaluate the Drug-drug Interaction Potential and Relative Bioavailability of Saruparib
Active, not recruitingNCT06899061
AstraZenecaAdvanced Solid Malignancies
Start: 2025-03-25End: 2026-04-30Updated: 2026-03-27
A Master Protocol Phase I/II Study to Investigate Biomarker‑Guided Novel Anticancer Agent(s) as Monotherapy or Combination Therapy for the Treatment of Participants with Advanced/Recurrent Ovarian Cancer (Ovarian Platform)
CompletedCTIS2024-519044-32-00
AstraZeneca ABAdvanced/Recurrent Ovarian cancer
Start: 2025-08-06End: 2025-11-25Target: 16Updated: 2025-11-12
A Master Protocol Study to Investigate Biomarker-guided Novel Anticancer Agent(s) as Monotherapy or Combination Therapy in Participants With Advanced/Recurrent Ovarian Cancer
WithdrawnNCT07060365
AstraZenecaAdvanced/Recurrent Ovarian Cancer
Start: 2025-09-02End: 2025-12-19Updated: 2026-04-03
Study of AZD4956 as Monotherapy and in Combination With Anti-Cancer Agents in Participants With Advanced/Metastatic Homologous Recombination Deficient Solid Tumours
RecruitingNCT07446855
AstraZenecaSolid Tumours
Start: 2026-03-17End: 2030-03-29Target: 180Updated: 2026-03-27
A Phase I/II, Modular, Open-Label, Multi-Centre Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of AZD9750 as Monotherapy and in Combination with Other Anticancer Agents in Participants with Metastatic Prostate Cancer (ANDROMEDA)
Not yet recruitingCTIS2024-516976-14-00
AstraZeneca ABMetastatic Prostate Cancer
Target: 52Updated: 2026-03-31

Phase 2

Phase 3

Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents
RecruitingNCT06120491
AstraZenecaMetastatic Castration-Sensitive Prostate Cancer
Start: 2023-11-21End: 2031-04-30Target: 1800Updated: 2026-04-03
A Randomized, 2-cohort, Double-blind, Placebo-controlled, Phase III Study of Saruparib (AZD5305) in Combination with Physician’s Choice New Hormonal Agents in Patients with HRRm and non-HRRm Metastatic Castration-Sensitive Prostate Cancer (EvoPAR-Prostate01).
RecruitingCTIS2023-504214-30-00
AstraZeneca ABMetastatic Castration-Sensitive Prostate Cancer (mCSPC)
Start: 2024-06-27Target: 540Updated: 2025-11-13
A Randomised, Open-Label, Phase III Study of Saruparib (AZD5305) Plus Camizestrant compared with Physician’s Choice CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant for the First-Line Treatment of Patients with BRCA1, BRCA2, or PALB2 Mutations and Hormone Receptor-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH non-amplified) Advanced Breast Cancer (EvoPAR-Breast01).
RecruitingCTIS2023-504180-16-00
AstraZeneca ABAdvanced Breast Cancer
Start: 2025-04-07Target: 136Updated: 2025-12-29
A Study of Metastases Free Survival With Saruparib vs Placebo Added to a Standard RT/ADT in Men With High-risk Prostate Cancer With a BRCA Mutation
RecruitingNCT06952803
AstraZenecaProstate Cancer
Start: 2025-08-06End: 2036-04-30Target: 700Updated: 2026-03-10
A Randomised, Double-blind, Placebo-controlled, Phase III Study of Adjuvant Saruparib (AZD5305) in Patients with BRCAm Localised High-risk Prostate Cancer Receiving Radiotherapy with Androgen Deprivation Therapy (EvoPAR-Prostate02)
RecruitingCTIS2024-513586-39-00
AstraZeneca ABProstate Cancer
Start: 2025-12-10Target: 253Updated: 2026-01-08

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