Ovarian cancer drug study pulled before it even started

NCT ID NCT07060365

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study aimed to test new cancer drugs, alone or in combination, for people with advanced or recurrent ovarian cancer. The treatments were chosen based on specific genetic markers in each person's tumor. However, the study was withdrawn before enrolling any participants, so no results are available.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Started

Sep 2025

Expected to finish

Dec 2025

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: Master Protocol: 1. 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. 2. Participants must provide sufficient archival or fresh tumour sample for biomarker testing. 3. Life expectancy at the time of screening ≥ 12 weeks in the opinion of the Investigator. 4. 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. 5. 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. 6. Adequate organ and marrow function. Substudy 1: 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. 2. Participants who are treatment-naïve. 3. Participants with evidence of predicted loss of function tBRCA1/2m (by local testing) as assessed by a commercially available diagnostic test. Key Exclusion Criteria: Master Protocol: 1. 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). 2. 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. 3. Active primary immunodeficiency/active infectious disease(s). 4. Participants with any known predisposition to bleeding (eg, active peptic ulceration, recent \[within 6 months\] haemorrhagic stroke, proliferative diabetic retinopathy). 5. Cardiac criteria, including history of arrhythmia and cardiovascular disease. 6. Prior malignancy that required treatment within 2 years prior to screening. 7. Previous allogeneic bone marrow or solid organ transplant. 8. As judged by the Investigator, any evidence of severe or uncontrolled systemic diseases or active uncontrolled infections. 9. Known allergy or hypersensitivity to investigational product(s) or any of the excipients of the investigational product(s) (as applicable to a substudy). 10. Concomitant use of drugs that are known to prolong or shorten QT and have a known risk of (Torsades de Pointes) TdP. 11. During the 4 weeks prior to the first dose, receiving continuous corticosteroids prednisone/day or equivalent for any reason. 12. Major surgical procedure (excluding placement of vascular access) or significant traumatic injury. 13. Any concurrent anticancer therapy. Substudy 1: 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. 2. 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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Advanced or recurrent epithelial ovarian cancer are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Research Site

    Barcelona, 08028, Spain