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Ovarian cancer drug safety check: what side effects did 354 patients report?

NCT ID NCT05021562

Knowledge-focused Sponsor: Takeda Source: ClinicalTrials.gov ↗

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 This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 looked at side effects of the drug niraparib (Zedula) in 354 people with ovarian cancer. Participants took niraparib capsules once a day as part of their normal care, and doctors recorded any side effects for one year. The main focus was on serious side effects like low blood cell counts, high blood pressure, and lung problems. This was an observational study, meaning the drug was not being tested for how well it works, only for safety.

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.

Participants

354 people

The number who actually took part.

Started

Sep 2021

Finished

Mar 2026

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.

Who is studied

An individual who corresponds to any of the following: ovarian cancer patients after initial chemotherapy (maintenance therapy), patients with platinum antineoplastic drug sensitive recurrent ovarian cancer (maintenance therapy), or recurrent ovarian cancer with platinum-sensitive homologous recombination repair defects.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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.

Inclusion Criteria: An individual who corresponds to any of the following: * Ovarian cancer patients after initial chemotherapy (maintenance therapy) * Patients with platinum antineoplastic drug sensitive recurrent ovarian cancer (maintenance therapy) * Recurrent ovarian cancer with platinum-sensitive homologous recombination repair defects. Exclusion Criteria: Has a history of hypersensitivity to any of the ingredients of this drug.

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Conditions

The condition(s) this trial relates to.

ovarian cancer

As listed by the trial registrant

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

Ovarian cancer

Contacts and locations

Locations

  • Takeda Selected Site

    Tokyo, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.