Table of contents
- Clinical trials overview
- Prostate cancer studies
- Breast cancer study
- Other advanced cancer studies
- Main trial endpoints
- Who may take part
- Trial status and phases
Clinical trials overview
The trial data show Saruparib being tested in several interventional studies, which means the research team gives a study treatment and watches what happens.[1] These studies include people with prostate cancer, breast cancer, pancreatic cancer, ovarian cancer, and other advanced solid tumors.[1]
The main goals across the trials are to check safety, tolerability, and efficacy, which means how well the treatment works against cancer.[1] Several studies also compare Saruparib with placebo or with other cancer treatments already used in practice.[1]
Prostate cancer studies
Several trials focus on prostate cancer, including metastatic castration-sensitive prostate cancer, metastatic prostate cancer, and high-risk localized or locally advanced prostate cancer with a BRCA mutation.[1] One Phase 3 study in men with metastatic castration-sensitive prostate cancer compares Saruparib plus a physician’s choice of new hormonal agents with placebo plus those same agents.[1]
Its main outcome is radiographic progression-free survival, which means the time until scans show the cancer has grown or the person dies from any cause.[1] The study is authorised and plans to enroll 1,805 participants.[1]
Another Phase 3 study looks at Saruparib added to standard radiotherapy and androgen deprivation therapy in men with high-risk prostate cancer and a BRCA mutation.[2] The main outcome is metastases-free survival, meaning the time until cancer first spreads to distant organs or the person dies.[2] This study is authorised and plans to enroll 700 participants.[2]
A Phase 1 study in metastatic prostate cancer tests Saruparib with new hormonal agents such as enzalutamide, abiraterone acetate, darolutamide, or apalutamide.[6] The study mainly checks for adverse events, which are unwanted medical problems that happen during the trial, and for dose limiting toxicities, meaning side effects that may limit how much treatment can be given.[6]
Another Phase 1/2 study in metastatic prostate cancer tests AZD9750 with or without other anticancer drugs, and Saruparib is listed among the study interventions.[7] The safety part measures adverse events, serious adverse events, and changes in lab tests, vital signs, ECGs, and performance status.[7] The efficacy part looks at the proportion of participants with at least a 50% fall in PSA, which is the prostate-specific antigen blood test.[7]
Breast cancer study
A Phase 3 study is testing Saruparib with camizestrant in adults with advanced breast cancer that is hormone receptor-positive and HER2-negative.[3] The comparison group uses a physician’s choice of CDK4/6 inhibitor plus endocrine therapy, which is hormone treatment for cancer.[3]
The main outcome is progression-free survival, meaning the time from randomisation until the cancer gets worse or the person dies.[3] This study is authorised and plans to enroll 500 participants.[3]
Other advanced cancer studies
A Phase 2 study tested Saruparib as first-line therapy for people with metastatic homologous repair-deficient pancreatic cancer.[4] Its main outcome was objective response rate at week 16, which shows how many people had a measurable tumor response on scans by RECIST criteria.[4] This study is completed and planned to enroll 700 participants.[4]
A Phase 1 study looked at Saruparib in advanced or recurrent ovarian cancer, with the main goal of safety and tolerability.[5] The safety endpoints included adverse events, serious adverse events, dose changes, procedure-related adverse events, and changes in vital signs, lab tests, ECGs, ECOG performance status, and physical exams.[5] This study is completed and planned to enroll 30 participants.[5]
A Phase 1/2 study in advanced solid tumors tests Saruparib alone and with other anti-cancer agents such as camizestrant, datopotamab deruxtecan, paclitaxel, and DS-8201a.[6] The main outcomes focus on safety, tolerability, dose-limiting toxicities, and the highest dose that can be given safely, called the maximum tolerated dose.[6]
Main trial endpoints
The trial endpoints are the main results researchers want to measure.[1] In these Saruparib studies, the most common endpoints are radiographic progression-free survival, metastases-free survival, progression-free survival, objective response rate, and safety outcomes.[1][2][3][4][5]
Safety endpoints often include adverse events, serious adverse events, lab tests, ECGs, vital signs, physical exams, and ECOG performance status.[5][6][7]
Some studies also use central review of scans, meaning expert reviewers check imaging results in a standard way, and blinded independent central review, where the reviewers do not know which treatment the person received.[2][3]
Who may take part
Most trials enroll adults with advanced, metastatic, recurrent, or high-risk cancer.[1][2][3][4][5][6][7]
Some studies require a specific tumor feature, such as a BRCA mutation or homologous repair deficiency, because these changes may affect how the cancer behaves.[2][4]
Other studies focus on people whose cancer has already spread, such as metastatic prostate cancer or metastatic breast or pancreatic cancer.[1][3][4][6][7]
Trial status and phases
The trial list includes both authorised and completed studies.[1] Authorised trials are allowed to start or continue, while completed trials have finished enrolling and following participants.[1]
The studies cover a wide range of phases: Phase 1, Phase 1/2, Phase 2, and Phase 3.[1] Early-phase trials mainly study safety and dose finding, while later-phase trials compare Saruparib with placebo or standard treatment and look at outcomes like survival and cancer control.[1][2][3]
