A trial to learn how safe saruparib is and how well it works in people with advanced ovarian cancer

Overview

Sponsor-declared trial summary

Key facts

Sponsor

AstraZeneca AB

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

6 Aug 2025 → 26 Nov 2025

Decision date (initial)

2025-07-07

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

AstraZeneca AB

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacodynamic, Pharmacokinetic, Efficacy

The primary objective of all substudies in this Master Protocol is safety and tolerability.

Secondary objectives 1

1. The secondary objective is Efficacy and Pharmacokinetic.

Conditions and MedDRA coding

Advanced/Recurrent Ovarian cancer

Study design 1 period

Regulatory references

Plan to share IPD

Yes

IPD plan description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. Participant must be of legal or over the legal age of consent in the jurisdiction in which the study is taking place, at the time of screening.
2. Participants must be female at birth.
3. Participants who have histologically or cytologically documented advanced or recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, considered to be suitable for treatment with study intervention, as applicable to each substudy.
4. Participants must provide sufficient archival or fresh tumour sample for biomarker testing, as outlined in the respective substudy Laboratory Manual.
5. Measurable disease as per RECIST 1.1 criteria: at least one lesion that can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes, which must have short axis ≥ 15 mm) with CT or MRI and is suitable for accurate repeated measurements.
6. ECOG PS of 0 to 1, with no deterioration over the previous 2 weeks prior to baseline at screening, and prior to study intervention administration.
7. Adequate organ and bone marrow function as described in substudy protocol.
8. Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
9. Participants must not breastfeed and must not donate or retrieve ova for their own use from screening to substudy-specified duration after the last dose of study intervention.
10. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in the CSP.

Exclusion criteria 12

1. Participants are eligible to be included in the study only if all of the following criteria (and all criteria from the respective substudy) apply. However, where specific substudy criteria differ from the master criteria below, the substudy criteria should be applied.
2. Persistent toxicities caused by previous anticancer therapies excluding alopecia, not yet improved to Grade ≤ 1 or baseline.
3. Any history of persisting (> 2 weeks) severe pancytopenia due to any cause.
4. Spinal cord compression or brain metastases unless asymptomatic, treated, and stable and not requiring continuous corticosteroids at a dose of > 10 mg prednisone/day or 2 mg/day of dexamethasone or equivalent for at least 4 weeks prior to start of study intervention. Participants with leptomeningeal carcinomatosis are excluded.
5. Active primary immunodeficiency/active infectious disease(s).
6. Uncontrolled intercurrent illness within the last 12 months, including but not limited to, ongoing or active known infection, active interstitial lung disease, serious chronic GI conditions associated with diarrhoea (eg, active inflammatory bowel disease); active non-infectious skin disease (including any grade rash, urticarial, dermatitis, ulceration, or psoriasis) requiring systemic treatment, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the participant to give written informed consent.
7. Participants with any known predisposition to bleeding.
8. Any cardiac criteria as described in the substudy CSP.
9. Any other cardiovascular diseases as described in the substudy CSP.
10. Prior malignancy (except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or of the cervix) that required treatment within 2 years prior to screening, whose natural history, in the Investigator’s opinion, has the potential to interfere with safety and efficacy assessments of the investigational regimen.
11. Known allergy or hypersensitivity to investigational product(s) or any of the excipients of the investigational product(s) (as applicable to a substudy).
12. Any concurrent anticancer therapy.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Safety endpoints will include, but are not limited to, the following: - TEAEs, SAEs, AEs leading to dose modifications, procedure-related AEs. -Changes from baseline in vital signs, clinical laboratory assessments, ECGs, ECOG PS, and physical examinations.

Secondary endpoints 3

1. The primary measure of interest is the estimate of ORR prior to IDS. Confirmation of response is not required.
2. The measure of interest is the estimate of confirmed CA125 response rate prior to IDS.
3. Plasma concentrations of saruparib and its metabolite(s) if applicable. Report plasma PK parameters, including but not limited to AUC, Cmax and tmax as data allow, of saruparib after single dose and/or multiple doses administration.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AstraZeneca AB

Sponsor organisation

AstraZeneca AB

Address

-

City

Sodertalje

Postcode

151 85

Country

Sweden

Scientific contact point

Organisation

AstraZeneca AB

Contact name

AstraZeneca Clinical Study Information Centre

Public contact point

Organisation

AstraZeneca AB

Contact name

AstraZeneca Clinical Study Information Centre

Third parties 1

Locations

2 EU/EEA countries · 11 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 19 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications