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GlioblastomaPhase 2NCT04221503

Niraparib/TTFields in GBM

A Phase 2 study testing Niraparib, Optune and Planned surgical resection in people with Glioblastoma and Recurrent Glioblastoma, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Evaluating the efficacy and safety of niraparib and Tumor-Treating Fields (TTFields) in recurrent glioblastoma (GBM). Read more about this study

Who is it for?
Ages 22 years and older
Conditions the study is for
Glioblastoma, Recurrent Glioblastoma, GBM
What is being tested?
Niraparib, Optune and Planned surgical resection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
30 Dec 2019to Jan 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 22 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histopathologically or molecularly (per c-IMPACT NOW criteria) proven diagnosis of glioblastoma which is recurrent following radiation therapy (prior dose must have been between 40 and 75 Gy).
  • Tumor O-6-methylguanine-deoxyribonucleic acid (DNA) methyltransferase (MGMT) methylation status must be available from any prior GBM tumor specimen.
  • Patients must have measurable contrast-enhancing disease (defined by at least 1cm x 1cm) by magnetic resonance imaging (MRI) imaging within 28 days of starting study treatment.
  • Patients may have had treatment for an unlimited number of prior relapses.
  • Patients must have recovered from severe toxicity of prior therapy.
  • Patients must be able to swallow oral medications.
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  • Karnofsky performance status >= 60.
  • Life expectancy >3 months.
  • Adequate hematologic parameters.
  • Adequate hepatic function within 7 days prior to start of study treatment.
  • Adequate renal function within 7 days prior to start of study treatment.
  • Reproductive Status
  • Women - negative serum or urine pregnancy test
  • Men and Women - must agree to an adequate method to avoid pregnancy
  • Participant must agree to not donate blood during the study or for 90 days after the last dose of niraparib.
  • Participant must, in the opinion of the Investigator, be able to comply with study procedures, including use of the Optune device.
  • Cohort B (surgical) patients only: patients must be undergoing surgery that is clinically indicated as determined by their care providers.
  • Cohort B (surgical) patients only: patients must have a tumor tissue form indicating availability of archived tissue from a previous surgery for glioblastoma.
  • Patients must be able to understand the study procedures and agree to participate in the study by providing written informed consent (or have legally authorized representative sign on patient's behalf if patient physically unable to sign consent due to neurologic deficit).

Who cannot join

  • Age < 22 years.
  • Prior treatment with tumor-treating fields therapy (Optune) within the past 6 months.
  • Prior treatment with a PARP inhibitor.
  • Known history or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML).
  • Patients with infratentorial tumor.
  • Participant has had any known Grade 3 or 4 anemia, neutropenia or thrombocytopenia due to prior chemotherapy that persisted > 4 weeks and was related to the most recent treatment.
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  • Participant must not have a serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent.
  • Implanted pacemaker, defibrillator or deep brain stimulator, other implanted electronic devices in the brain. Non-programmable shunts are allowed. Patients with a programmable shunt are excluded.
  • Skull defects.
  • Known hypersensitivity to conductive hydrogels or known hypersensitivity to niraparib components or excipients.
  • Patients with gastrointestinal disorders or abnormalities that would interfere with absorption of study treatment.
  • Prisoners or subjects who are involuntarily incarcerated.
  • Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
  • Participant must not be simultaneously enrolled in any interventional clinical trial.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: A Phase II Study Evaluating the Efficacy and Safety of Niraparib and Tumor-Treating Fields in Recurrent Glioblastoma

Evaluating the efficacy and safety of niraparib and Tumor-Treating Fields (TTFields) in recurrent glioblastoma (GBM).

Read the detailed description

Tumor-treating fields (TTFields) causes downregulation of BRCA1 signaling and reduced deoxyribonucleic acid (DNA) double-strand break repair capacity. Tumors that are deficient in the homologous recombination DNA damage repair pathway are highly sensitive to blockade of the repair of single strand DNA breaks via poly-ADP ribose polymerase (PARP) inhibition. This is a study of niraparib, a PARP inhibitor, in combination with tumor-treating fields for recurrent glioblastoma. We hypothesize that tumor-treating fields will induce a state of "BRCAness" in the glioma tumor cells, thus sensitizing them to PARP inhibition and resulting in tumor cell death.

Being tested
Niraparib, Optune, Planned surgical resection
Medical subject headings
Glioblastoma

What participants receive

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

  • NiraparibDrug

    Also called ZEJULA

    Niraparib ([3S]-3-[4-{7-(aminocarbonyl)-2H-indazol-2-yl} phenyl] piperidine [tosylate monohydrate salt]) is an orally available, potent, highly selective poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) -1 and -2 inhibitor. The niraparib drug product is provided as 100-mg capsules filled with a dry blend of niraparib tosylate monohydrate, lactose monohydrate, and magnesium stearate in a hard gelatin capsule.

  • OptuneDevice

    Also called Tumor Treatment Fields (TTFields)

    Optune, which is manufactured by Novocure, is a portable battery or power supply operated device which produces alternating electrical fields, called tumor treatment fields ("TTFields") within the human body. TTFields are applied to the patient by electrically-insulated surface transducer arrays. TTFields disrupt the rapid cell division exhibited by cancer cells.

  • Planned surgical resectionProcedure or surgery

    Also called Tumor Resection

    Surgery of supratentorial glioblastoma (GBM).

Study groups in NCT04221503
Study groupRoleWhat they receive
Cohort AExperimentalCohort A is for subjects with recurrent glioblastoma who do not have clinical indication for surgical resection of the recurrent tumor. Subjects in Cohort A will initiate and continue TTFields therapy for 5-7 days prior to starting niraparib.
Receives: Drug: Niraparib; Device: Optune
Cohort BActive comparatorCohort B is for subjects with recurrent glioblastoma who have a clinical indication for surgical resection of the recurrent tumor. Subjects in Cohort B will receive TTFields for 5-7 days prior to planned surgical resection, undergo surgical resection, resume TTFields postoperatively, and initiate niraparib 5- 7 days after starting TTFields postoperatively.
Receives: Drug: Niraparib; Device: Optune; Procedure: Planned surgical resection

What is being measured

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

  1. Disease control, defined as achievement of either CR, PR, or SD, as defined by modified Response Assessment in Neuro-Oncology (mRANO) criteria.

    Complete response (CR) is seen as the disappearance of all enhancing measurable and non-measurable disease sustained for at least 4 weeks.

    Partial response (PR) is ≥50% decrease in sum of products of perpendicular diameters or ≥65% decrease in total volume of all measurable enhancing lesions compared with baseline, sustained for at least 4 weeks.

    Stable disease (SD), must be present on two consecutive MRI scans, with the 2nd/confirmatory MRI performed at least 16 weeks after starting treatment.

    Measured: When termination of the study or 5 years after removal from protocol therapy, whichever occurs first.

Secondary outcomes (5)

  1. Number of AEs (Adverse Events)

    Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0, all events will be recorded from the time a subject has signed the informed consent form.

    Measured: When termination of the study or 5 years after removal from protocol therapy, whichever occurs first.

  2. Duration of disease control.

    Achieving a confirmed best response to treatment of stable disease (SD), partial response (PR), or complete response (CR).

    Measured: When termination of the study or 5 years after removal from protocol therapy, whichever occurs first.

  3. Objective radiographic response (ORR)

    ORR is defined by mRANO criteria, and duration of response.

    Measured: When termination of the study or 5 years after removal from protocol therapy, whichever occurs first.

  4. Progression-free survival (PFS)

    Progression-free survival (PFS) is defined as the time from date of enrollment until the earliest date of disease progression (as determined by mRANO criteria) or death due to any cause.

    Measured: When termination of the study or 5 years after removal from protocol therapy, whichever occurs first.

  5. Overall survival (OS)

    Overall survival (OS) is defined as the time from date of enrollment until death from any cause.

    Measured: When termination of the study or 5 years after removal from protocol therapy, whichever occurs first.

Timeline

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

  1. First posted9 Jan 2020
  2. Study start30 Dec 2019
  3. Primary completionJan 2026 (estimated)
  4. Study completionJan 2026 (estimated)

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04221503
Sponsor's protocol ID
03319
Status last verified
Jan 2026
First submitted
17 Dec 2019
Last updated
8 Jan 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Niraparib, Optune and Planned surgical resection in people with Glioblastoma and Recurrent Glioblastoma, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.

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 19 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 8 Jan 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 United States. 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 phase mean?

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?

This study is still under way. Results are not available in the source record yet.

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?

Disease control, defined as achievement of either CR, PR, or SD, as defined by modified Response Assessment in Neuro-Oncology (mRANO) criteria. (time frame: When termination of the study or 5 years after removal from protocol therapy, whichever occurs first.). 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 NCT04221503.

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 8 Jan 2026.

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