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Advanced/Recurrent Ovarian CancerPhase 1/2NCT07060365

A Master Protocol Study to Investigate Biomarker-guided Novel Anticancer Agent(s) as Monotherapy or Combination Therapy in Participants With Advanced/Recurrent Ovarian Cancer

A Phase 1/2 study testing Saruparib in people with Advanced/Recurrent Ovarian Cancer, run by AstraZeneca at 1 site in Spain.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The main purpose of this study is to investigate the safety, tolerability, preliminary efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of biomarker-guided novel anticancer agent(s) as monotherapy or combination therapy for the treatment of participants with advanced/recurrent ovarian cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Advanced/Recurrent Ovarian Cancer
What is being tested?
Saruparib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteSpain
Study dates
2 Sep 2025to 19 Dec 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Master Protocol:
  • 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.
  • Life expectancy at the time of screening ≥ 12 weeks in the opinion of the Investigator.
  • 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.
  • 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.
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  • Adequate organ and marrow function.
  • Substudy 1:
  • Participants must have histologically or cytologically confirmed newly diagnosed FIGO 2014 Stage III/IV epithelial ovarian*, fallopian tube, or primary peritoneal cancer who are eligible for neoadjuvant treatment with planned IDS.
  • Participants who are treatment-naïve.
  • Participants with evidence of predicted loss of function tBRCA1/2m (by local testing) as assessed by a commercially available diagnostic test.

Who cannot join

  • Master Protocol:
  • Any history of persisting (> 2 weeks) severe pancytopenia due to any cause (absolute neutrophil count < 0.5 × 10/Liters (L) or platelets < 50 × 10/L).
  • Spinal cord compression or brain metastases unless asymptomatic, treated, and stable and not requiring continuous corticosteroids prednisone/day or dexamethasone or equivalent for at least 4 weeks prior to start of study intervention. Participants with leptomeningeal carcinomatosis are excluded.
  • Active primary immunodeficiency/active infectious disease(s).
  • Participants with any known predisposition to bleeding (eg, active peptic ulceration, recent [within 6 months] haemorrhagic stroke, proliferative diabetic retinopathy).
  • Cardiac criteria, including history of arrhythmia and cardiovascular disease.
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  • Prior malignancy that required treatment within 2 years prior to screening.
  • Previous allogeneic bone marrow or solid organ transplant.
  • As judged by the Investigator, any evidence of severe or uncontrolled systemic diseases or active uncontrolled infections.
  • Known allergy or hypersensitivity to investigational product(s) or any of the excipients of the investigational product(s) (as applicable to a substudy).
  • Concomitant use of drugs that are known to prolong or shorten QT and have a known risk of (Torsades de Pointes) TdP.
  • During the 4 weeks prior to the first dose, receiving continuous corticosteroids prednisone/day or equivalent for any reason.
  • Major surgical procedure (excluding placement of vascular access) or significant traumatic injury.
  • Any concurrent anticancer therapy.
  • Substudy 1:
  • Participants with history of myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML) or with features suggestive of MDS/AML (as determined by prior diagnostic investigation). Specific screening for MDS/AML is not required.
  • Refractory nausea and vomiting, clinical signs or symptoms of Gastrointestinal (GI) obstruction and/or requirement for parenteral hydration or nutrition, history of prior intestinal obstruction, chronic GI diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of saruparib.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Research Site

    Barcelona, 08028

Other trials in Spain

About this study

Official title: 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 main purpose of this study is to investigate the safety, tolerability, preliminary efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of biomarker-guided novel anticancer agent(s) as monotherapy or combination therapy for the treatment of participants with advanced/recurrent ovarian cancer.

Substudy 1 will investigate the safety, tolerability, preliminary efficacy, PK and PD of saruparib monotherapy in participants with BReast CAncer gene (BRCA) mutated epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Read the detailed description

This Phase I/II, open-label, multicentre study will employ a platform design utilising a Master Protocol with multiple parallel, open-label substudies.

Substudy 1 is a single-arm, open label, Phase II multicentre study investigating the safety, tolerability, preliminary efficacy, PK, and PD of saruparib monotherapy, as neoadjuvant treatment in participants with newly diagnosed, tBRCA1/2m International Federation of Gynecology and Obstetrics (FIGO) 2014 Stage III/IV epithelial ovarian, fallopian tube, or primary peritoneal cancer, and who are eligible for neoadjuvant treatment with planned interval debulking surgery (IDS).

Being tested
Saruparib
Keywords
Novel Anticancer Agent, Biomarker-Guided, Novel PARPi, BRCA1/2m, Neoadjuvant treatment
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SaruparibDrug

    Participants will receive saruparib via oral administration.

Study groups in NCT07060365
Study groupRoleWhat they receive
SaruparibExperimentalParticipants will receive saruparib via oral administration.
Receives: Drug: Saruparib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with treatment-emergent adverse event (TEAEs), serious adverse events (SAEs), and adverse events (AEs) leading to discontinuation

    To assess the safety and tolerability of novel biomarker guided treatment in participants with advanced/recurrent ovarian cancer.

    Measured: From Day 1 to Survival Follow up (approximately 6 months)

Secondary outcomes (7)

  1. Substudy 1: Estimate of objective response rate (ORR) defined as proportion of participants who have a complete or partial response

    To estimate the efficacy of neoadjuvant treatment (and prior to IDS) with saruparib single-agent by assessment of ORR in participants with newly diagnosed tBRCA1/2m advanced epithelial ovarian cancer and with measurable disease at baseline.

    Measured: From Day 1 to IDS surgery (within 6 weeks after conclusion of study intervention treatment [Day 1 until 12 weeks])

  2. Substudy 1: Estimate of confirmed cancer antigen 125 (CA125) response rate defined as at least 50% reduction in serum CA-125 levels from pre-treatment levels

    To estimate the efficacy of neoadjuvant treatment (and prior to IDS) with saruparib single-agent in participants with newly diagnosed tBRCA1/2m advanced epithelial ovarian cancer and evaluable for CA125 response per the GCIG criteria.

    Measured: Screening (Day -28), Day 1 (Cycle 1) and Day 15 (Cycle 2) (28-day cycles), End of Treatment (7 days after final dose), Pre-surgery Follow up

  3. Substudy 1: Proportion of participants with pathological complete response (pCR) defined as no macroscopic residual and no microscopic (viable) disease on histologic evaluation of all surgical specimens

    To estimate the efficacy of neoadjuvant treatment with saruparib single-agent by assessment of pCR in participants with newly diagnosed tBRCA1/2m advanced epithelial ovarian cancer and with measurable disease at baseline.

    Measured: IDS Follow up period (IDS surgery within 6 weeks after conclusion of study intervention treatment [Day 1 until 12 weeks])

  4. Substudy 1: Proportion of participants with complete surgical resection of tumour at IDS defined as no macroscopic tumour remains after surgery

    To estimate the efficacy of neoadjuvant treatment with saruparib single-agent by assessment of CRR in participants with newly diagnosed tBRCA1/2m advanced epithelial ovarian cancer and with measurable disease at baseline.

    Measured: IDS Follow up period (IDS surgery within 6 weeks after conclusion of study intervention treatment [Day 1 until 12 weeks])

  5. Substudy 1: Area under the plasma drug concentration-time curve (AUC)

    To characterise the PK of saruparib and its metabolite(s) if applicable, as monotherapy in plasma following a single dose and at steady state after multiple dosing, when given orally as neoadjuvant monotherapy prior to IDS participants with newly diagnosed tBRCA1/2m advanced epithelial ovarian cancer.

    Measured: Day 1 (Cycle 1 and Cycle 3) (28-day cycles)

  6. Substudy 1: Maximum plasma concentration of the drug (Cmax)

    To characterise the PK of saruparib and its metabolite(s) if applicable, as monotherapy in plasma following a single dose and at steady state after multiple dosing, when given orally as neoadjuvant monotherapy prior to IDS participants with newly diagnosed tBRCA1/2m advanced epithelial ovarian cancer.

    Measured: Day 1 (Cycle 1 and Cycle 3) (28-day cycles)

  7. Substudy 1: Time to maximum plasma concentration (tmax)

    To characterise the PK of saruparib and its metabolite(s) if applicable, as monotherapy in plasma following a single dose and at steady state after multiple dosing, when given orally as neoadjuvant monotherapy prior to IDS participants with newly diagnosed tBRCA1/2m advanced epithelial ovarian cancer.

    Measured: Day 1 (Cycle 1 and Cycle 3) (28-day cycles)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2025
  2. Study start2 Sep 2025
  3. Primary completion19 Dec 2025 (estimated)
  4. Study completion19 Dec 2025 (estimated)

Why it stopped: The study termination is based on Sponsor decision and is not related to any safety, efficacy or quality concerns.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07060365
Sponsor's protocol ID
D9724C00001
Status last verified
Mar 2026
First submitted
24 Jun 2025
Last updated
3 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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 shared.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Saruparib in people with Advanced/Recurrent Ovarian Cancer, run by AstraZeneca at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with treatment-emergent adverse event (TEAEs), serious adverse events (SAEs), and adverse events (AEs) leading to discontinuation (time frame: From Day 1 to Survival Follow up (approximately 6 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07060365.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.

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