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

Trial details

Who runs it

AstraZeneca AB

Trial code

EU 2024-519044-32-00

Record updated

2025. november 12.

Original description

The primary objective of all substudies in this Master Protocol is safety and tolerability.Read full original descriptionShow less

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)

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

Inclusion: 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; Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in the CSP; Participants must be female at birth; 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; Participants must provide sufficient archival or fresh tumour sample for biomarker testing, as outlined in the respective substudy Laboratory Manual; 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; 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; Adequate organ and bone marrow function as described in substudy protocol; Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies; 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.

Exclusion: Known allergy or hypersensitivity to investigational product(s) or any of the excipients of the investigational product(s) (as applicable to a substudy); Any concurrent anticancer therapy; Persistent toxicities caused by previous anticancer therapies excluding alopecia, not yet improved to Grade ≤ 1 or baseline; 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; 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; Any history of persisting (> 2 weeks) severe pancytopenia due to any cause; Active primary immunodeficiency/active infectious disease(s); 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; Participants with any known predisposition to bleeding; Any cardiac criteria as described in the substudy CSP; Any other cardiovascular diseases as described in the substudy CSP; 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.

EU CTIS 2024-519044-32-00