Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Saruparib (AZD5305)
Saruparib · 7 trials · 6 indications
Radiographic PFS (rPFS) is the primary endpoint of this study, defined as the time from randomization to radiographic progression, as assessed by the investigator per RECIST 1.1 (soft tissue) and/or PCWG3 criteria (bone), or death due to any cause.
MFS is defined as the time from randomisation until the date of first appearance of distant metastases, confirmed by standard clinical imaging \[computed tomography (CT)/ magnetic resonance imaging (MRI) and bone scan, or prostate-specific membrane antigen-positron emission tomography (PSMA-PET)\], as assessed by blinded independent central review (BICR) or death due to any cause.
PFS is defined as time from randomisation until progression per RECIST v1.1 as assessed by BICR, or death due to any cause.
AUCinf
AUCinf
Cumulative amount excreted in urine, faeces and total (urine and faeces combined)
Amount excreted and cumulative amount excreted in urine, faeces and total (urine and faeces combined) expressed as a percentage of the administered dose.
AUClast
Cmax
tmax
t1/2(lambda)z
To evaluate the effects of saruparib on the PK of substrates of human drug transporters digoxin, furosemide, metformin hydrochloride, and rosuvastatin in participants with advanced solid malignancies.
To evaluate the effects of saruparib on the PK of substrates of human drug transporters digoxin, furosemide, metformin hydrochloride, and rosuvastatin in participants with advanced solid malignancies.
To evaluate the effects of saruparib on the PK of substrates of human drug transporters digoxin, furosemide, metformin hydrochloride, and rosuvastatin in participants with advanced solid malignancies.
To assess the relative bioavailability of saruparib tablets manufactured using a DC process versus RC process under fasted conditions.
To assess the relative bioavailability of saruparib tablets manufactured using a DC process versus RC process under fasted conditions.
To assess the relative bioavailability of saruparib tablets manufactured using a DC process versus RC process under fasted conditions.
To evaluate the effect of rabeprazole on saruparib PK profile following the administration of saruparib DC tablets.
To evaluate the effect of rabeprazole on saruparib PK profile following the administration of saruparib DC tablets.
To evaluate the effect of rabeprazole on saruparib PK profile following the administration of saruparib DC tablets.
To assess the effects of study treatment on γH2AX change in participants with localised prostate cancer
| Arm | Type | Description |
|---|---|---|
| Saruparib (AZD5305) + Physician's Choice ARPI - enzalutamide, darolutamide, or abiraterone | EXPERIMENTAL | Saruparib 60 mg + ARPI (enzalutamide, darolutamide, or abiraterone) : Participants will receive saruparib 60 mg orally once daily in combination with physician's choice of ARPI in cycles of 28 days |
| Placebo + Physician's Choice ARPI - enzalutamide, darolutamide, or abiraterone | PLACEBO_COMPARATOR | Placebo + ARPI (enzalutamide, darolutamide, or abiraterone): Participants will receive placebo orally once daily in combination with physician's choice of ARPI in cycles of 28 days |
| Cohort A: Saruparib (AZD5305) + Physician's Choice ADT | EXPERIMENTAL | Participants will receive saruparib along with ADT. |
| Cohort A: Placebo + Physician's Choice ADT | PLACEBO_COMPARATOR | Participants will receive matching placebo to saruparib along with ADT. |
| Cohort B: Saruparib (AZD5305) + Physician's Choice ADT + Abiraterone (and prednisone/prednisolone) | EXPERIMENTAL | Participants will receive saruparib, abiraterone and prednisolone/prednisone along with ADT. |
| Cohort B: Placebo + Physician's Choice ADT + Abiraterone (and prednisone/prednisolone) | PLACEBO_COMPARATOR | Participants will receive matching placebo to saruparib, abiraterone and prednisolone/prednisone along with ADT. |
| Arm 1: saruparib (AZD5305) plus camizestrant | EXPERIMENTAL | participants will receive saruparib (AZD5305) orally and camizestrant orally |
| Arm 2: Physician's choice CDK4/6i plus physician's choice ET | ACTIVE_COMPARATOR | agents are indicated below and should follow local guidelines: * Physician's Choice CDK4/6i: * abemaciclib orally, or * ribociclib orally, or * palbociclib orally. * Physician's Choice ET: * fulvestrant intramuscularly, or * One of the following AIs: * letrozole orally, or * anastrozole orally, or * exemestane orally |
| Arm 3: Physician's choice CDK4/6i plus camizestrant | EXPERIMENTAL | participants will receive camizestrant orally. Agents for CDK4/6i treatment are indicated above and should follow local guidelines |
| Arm 4: Saruparib (AZD5305) plus physician's choice ET | EXPERIMENTAL | participants will receive Saruparib (AZD5305) plus -Physician's Choice ET: * fulvestrant intramuscularly, or * One of the following AIs: * letrozole orally, or * anastrozole orally, or * exemestane orally |
| Arm 1: Saruparib (AZD5305) + Physician's Choice NHA | EXPERIMENTAL | Saruparib (AZD5305) + physician's choice NHA (Abiraterone, Darolutamide, or Enzalutamide) |
| Arm 2: Placebo + Physician's Choice NHA | PLACEBO_COMPARATOR | Placebo + physician's choice NHA (Abiraterone, Darolutamide, or Enzalutamide) |
| Primary Treatment Arm - AZD5305 | EXPERIMENTAL | Part A will assess absolute bioavailability via oral administration of Saruparib (AZD5305) and IV \[14C\]-saruparib microtracer. Part B will assess ADME via IV \[14C\]-saruparib administration |
| Treatment Cohort (Module 1) | ACTIVE_COMPARATOR | Period 1: participants will receive a single oral dose of cocktail substrate (digoxin, furosemide, metformin hydrochloride, and rosuvastatin) on Day 1. Period 2: participants will receive a single dose saruparib from Day 1 to 9, and a single dose of cocktail substrate on Day 5 in combination with saruparib. Period 3: participants will receive a single oral dose of saruparib daily. |
| Saruparib RC Cohort (Module 2) | ACTIVE_COMPARATOR | Period 1: participants will receive a single dose of RC saruparib. Period 2: participants will receive a single dose of DC saruparib. Period 3: participants will receive rabeprazole twice daily from Day 1 to 3, and a single dose of rabeprazole prior to DC saruparib on Day 4. Period 4: participants will receive RC saruparib daily for up to 3 cycles. |
| Saruparib DC Cohort (Module 2) | ACTIVE_COMPARATOR | Period 1: participants will receive a single dose of DC saruparib. Period 2: participants will receive a single dose of RC saruparib. Period 3: participants will receive rabeprazole twice daily from Day 1 to 3, and a single dose of rabeprazole prior to DC saruparib on Day 4. Period 4: participants will receive RC saruparib daily for up to 3 cycles. |
| Saruparib (AZD5305) only | OTHER | Participant will receive Saruparib (AZD5305) once daily for 21 days (+ up to 7 days) unless unacceptable toxicity or withdrawal of consent. Following the 21 days of study treatment, participants should undergo radical prostatectomy on Day 22 (+ up to 7 days) |
| Saruparib (AZD5305) + Darolutamide | OTHER | Participant will receive Saruparib (AZD5305) once daily + darolutamide twice daily for 21 days (+ up to 7 days) unless unacceptable toxicity or withdrawal of consent. Following the 21 days of study treatment, participants should undergo radical prostatectomy on Day 22 (+ up to 7 days). |
| No Treatment | OTHER | No study treatment is to be taken by the participants in this arm. Radical prostatectomy should be performed as per local practice |
| Darolutamide Only | OTHER | Participant will receive darolutamide twice daily for 21 days (+ up to 7 days) unless unacceptable toxicity or withdrawal of consent. Following the 21 days of study treatment, participants should undergo radical prostatectomy on Day 22 (+ up to 7 days). |
| Name | Type | Description |
|---|---|---|
| Saruparib | DRUG | Arm 1: Saruparib (AZD5305) + Physician's Choice ARPI (enzalutamide, darolutamide, or abiraterone) |
| Placebo | OTHER | Arm 2: Placebo + Physician's Choice ARPI (enzalutamide, darolutamide, or abiraterone) |
| Enzalutamide | DRUG | Arm 1: Saruparib (AZD5305) + Physician's Choice ARPI (enzalutamide, darolutamide, or abiraterone) Arm 2: Placebo + Physician's Choice ARPI |
| Darolutamide | DRUG | Arm 1: Saruparib (AZD5305) + Physician's Choice ARPI (enzalutamide, darolutamide, or abiraterone) Arm 2: Placebo + Physician's Choice ARPI |
| Abiraterone | DRUG | Arm 1: Saruparib (AZD5305) + Physician's Choice ARPI (enzalutamide, darolutamide, or abiraterone) Arm 2: Placebo + Physician's Choice ARPI |
| Abiraterone + Prednisolone/Prednisone | DRUG | Abiraterone will be administered orally in combination with prednisone/prednisolone. |
| Androgen Deprivation Therapy (ADT) | DRUG | Standard of care ADT will be administered. |
| Saruparib (AZD5305) | DRUG | Saruparib (AZD5305) is a potent and selective inhibitor of PARP1, with minimal effect on PARP2. |
| Camizestrant | DRUG | Camizestrant (AZD9833) is an orally bioavailable, next generation SERD with non-clinical and clinical activity in both ESR1 mutant and wild type settings . |
| Abemaciclib | DRUG | CDK4/6 Inhibitor |
| Ribociclib | DRUG | CDK4/6 Inhibitor |
| Palbociclib | DRUG | CDK 4/6 Inhibitor |
| Fulvestrant | DRUG | Endocrine Therapy |
| Letrozole | DRUG | Endorcine Therapy |
| Anastrozole | DRUG | Endocrine Therapy |
| Exemestane | DRUG | Endocrine Therapy |
| Abiraterone Acetate | DRUG | Oral |
| [14C]-AZD5305 microtracer | DRUG | IV radiolabeled microtracer |
| [14C]-AZD5305 (therapeutic dose) | DRUG | IV radiolabeled PARP inhibitor |
| Digoxin | DRUG | Period 1: participants will receive a single oral dose of a cocktail of substrates (digoxin, furosemide, metformin hydrochloride, and rosuvastatin) on Day 1. Period 2: participants will receive a single oral dose of the cocktail of substrates in combination with saruparib on Day 5. |
| Furosemide | DRUG | Period 1: participants will receive a single oral dose of a cocktail of substrates (digoxin, furosemide, metformin hydrochloride, and rosuvastatin) on Day 1. Period 2: participants will receive a single oral dose of the cocktail of substrates in combination with saruparib on Day 5. |
| Metformin Hydrochloride | DRUG | Period 1: participants will receive a single oral dose of a cocktail of substrates (digoxin, furosemide, metformin hydrochloride, and rosuvastatin) on Day 1. Period 2: participants will receive a single oral dose of the cocktail of substrates in combination with saruparib on Day 5. |
| Rosuvastatin | DRUG | Period 1: participants will receive a single oral dose of a cocktail of substrates (digoxin, furosemide, metformin hydrochloride, and rosuvastatin) on Day 1. Period 2: participants will receive a single oral dose of the cocktail of substrates in combination with saruparib on Day 5. |
| Rabeprazole | DRUG | Period 3: Participants will receive two doses of rabeprazole per day from Day 1 to 3. On Day 4, participants will receive a dose of rabeprazole followed by DC saruparib. |
| No Treatment | OTHER | No study treatment is to be taken by the participants in this arm. Radical prostatectomy should be performed as per local practice |
Inclusion Criteria: * Participant must be ≥ 18 at the time of signing the informed consent. * Histologically documented diagnosis of prostate adenocarcinoma that is de novo or recurrent and hormone-sensitive. * Metastatic disease confirmed prior to initiation of previous treatment with docetaxel or...
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Saruparib is an investigational small molecule being studied for multiple cancers, including metastatic hormone-sensitive prostate cancer (mHSPC), metastatic castration-sensitive prostate cancer, advanced breast cancer, and advanced solid malignancies. It is currently in Phase 3 clinical trials for prostate and breast cancer indications.
Saruparib is a PARP inhibitor, as indicated by its '-parib' target class. It is being evaluated in combination with other therapies for cancers with specific genetic mutations, such as BRCA1, BRCA2, or PALB2 in advanced breast cancer.
Saruparib is being developed by AstraZeneca PLC, a global biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. AstraZeneca is conducting multiple clinical trials to evaluate the drug's safety and efficacy in various cancer indications.
Saruparib is in Phase 3 clinical development for metastatic hormone-sensitive prostate cancer, metastatic castration-sensitive prostate cancer, and advanced breast cancer. It is also being studied in a Phase 1 trial for advanced solid malignancies. Saruparib is investigational and not yet approved by regulatory authorities.
Saruparib is being studied in several clinical trials, including NCT06120491, a Phase 3 trial in metastatic castration-sensitive prostate cancer; NCT06380751, a Phase 3 trial in advanced breast cancer; NCT06899061, a Phase 1 drug-drug interaction study; and NCT07711002, a Phase 3 trial in mHSPC.
Yes, Saruparib is also known as AZD5305. The drug is referred to by both names in clinical trial documentation and scientific literature. Researchers and investors may encounter either name when searching for information about this investigational PARP inhibitor.