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Ovarian CancerPhase 2NCT05961124

Alternative Dosing Of Niraparib To Decrease Dose Interruption In First Line Maintenance Treatment For Ovarian Cancer

A Phase 2 study testing Niraparib in people with Ovarian Cancer and Stage III Ovarian Cancer, run by Sunnybrook Health Sciences Centre at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to test alternative dosing of niraparib in patients with newly diagnosed high-grade, advanced stage ovarian cancer. The main questions it aims to answer are: What is the incidence of hematologic and other adverse events? What is the incidence of dose interruption, dose reduction and… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Niraparib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteCanada
Study dates
21 Aug 2023to Sep 2027
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 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must be able to understand the study, agree to participate and provide written, informed consent
  • Patients must be female and age >/= 18 years of age
  • Newly diagnosed, histologically confirmed, high-grade serous and grade 3 endometrioid ovarian, primary peritoneal, or fallopian tube cancer undergoing frontline treatment
  • Stage III and IV cancer according to International Federation of Gynecology and Obstetrics (FIGO) 2018 criteria and all patients undergoing neoadjuvant chemotherapy (NACT)
  • Patients must meet the following front-line treatment requirements:
  • Patients must have completed a minimum of 4 cycles of platinum-based chemotherapy (carboplatin, cisplatin, oxaliplatin). Primary or interval debulking therapy and intraperitoneal chemotherapy are allowed.
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  • Patients must have a complete response or partial tumor response (no lesion >1cm) to platinum-based regimen
  • CA-125 must be either:
  • CA-125 in normal range or
  • CA-125 decreased by 90% during front-line treatment and stable for a minimum of 7 days (does not increase by more than 15%) iv. Study drug can start within 12 weeks of completing chemotherapy
  • Patients must be post-menopausal with no menses for >1 year, or surgically sterilized, or willing to use adequate contraception to prevent pregnancy or abstain from intercourse and agrees not to donate eggs for the purpose of reproduction from study enrollment until 6 months following the last dose of treatment.
  • Patients of childbearing potential must have a negative serum or urine pregnancy test (beta human chorionic gonadotropin [hcg]) within 3 days prior to receiving the first dose of study treatment.
  • Eastern Cooperative Oncology Group (ECOG) status of 0 or 1
  • Patients must have adequate organ function at enrollment, as follows:
  • Absolute neutrophil count >/= 1.5 x109/L ii. Platelets >/= 100 x109/L iii. Hemoglobin >/= 100 g/L without transfusion iv. Creatinine clearance >/= 60 mL/min using the Cockcroft-Gault equation v. Total bilirubin </= 1.5 times the upper limit of normal (ULN) or direct bilirubin < 1 times the upper limit of normal vi. Aspartate aminotransferase and Alanine aminotransferase ≤ 2.5 x ULN unless liver metastases are present, in which case they must be ≤ 5 x ULN
  • Patients with hypertension should have their blood pressure adequately treated and controlled prior to starting study treatment
  • Patients must be able to take oral medications
  • Patients must agree to complete blood samples prior to cycle 1, then weekly for the first month and as outlined in the protocol

Who cannot join

  • Patient's age is <18 years.
  • Patient who are pregnant, breastfeeding, or expecting to conceive children during the study treatment of for 6 months after completion of the study treatment.
  • Patients with a known hypersensitivity to niraparib or any of its components
  • Patients who have received a poly adenosine diphosphate-ribose polymerase (PARP) inhibitor as part of their previous treatment or participated in a trial where PARP inhibitors were administered in one arm of the trial.
  • Patients enrolled in another investigational trial
  • Patients who received another investigational therapy within 4 weeks or 5 halflives of the investigational agent, whichever is longer
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  • Patients with previous persistent (>4 weeks) or >/= grade 3 hematologic toxicity or fatigue from prior cancer therapy.
  • Patients with known history of myelodysplastic syndrome or pre-treatment cytogenetic testing at risk for myelodysplastic syndrome or acute myeloid leukemia
  • Patients receiving concurrent, prohibited medications
  • Patients with previous major surgery within 3 weeks of starting study treatment and must have recovered from any effects of previous surgery.
  • Patients with ascites drained within 4 weeks of starting study treatment
  • Patients receiving palliative radiotherapy to >20% of bone marrow within 2 weeks or any other radiotherapy within 1 week of study treatment
  • Patients receiving a transfusion (platelets or red blood cells) within 4 weeks of treatment
  • Patients planning to donate blood during the study or 90 days after treatment.
  • Patients with a diagnosis of another invasive cancer (other than ovarian cancer), within 2 years prior to randomization (except basal or squamous cell carcinoma of the skin that has been definitively treated i. Patients with uncontrolled brain or leptomeningeal metastases. Controlled brain or leptomeningeal metastasis is defined as: ii. Central nervous system disease that has undergone treatment with radiation or chemotherapy > 1 month before study entry
  • No new or progressive signs or symptoms, stable steroid dose x 4 weeks or not taking steroids
  • Patients considered poor medical risk due to serious, uncontrolled medical disorder, non-malignant systemic disease, or active uncontrolled infection i. Patients with known HIV considered high risk for serious and fatal outcome
  • Patients with evidence of any condition, therapy, or laboratory abnormality that might confound study results or patient participation for full duration of study (Ex. Myelodysplastic syndrome, anemia, leukopenia, neutropenia, thrombocytopenia, etc)
  • Patients who are immunocompromised (Patients with splenectomy are allowed)
  • Patients with known, active hepatic disease (Ex. Hepatitis B or C), active biliary disease (exceptions for Gilbert's syndrome, asymptomatic gallstones, liver metastases or otherwise stable chronic liver disease as per investigator assessment)
  • Patients with QT prolongation >470 milliseconds at screening
  • Patients with a known breast cancer susceptibility gene (BRCA1 and 2) mutation (as they routinely receive olaparib at our institution) If BRCA unknown they are not excluded.
  • Patients with a history of posterior reversible encephalopathy syndrome (PRES)
  • Patients who have had a live vaccine within 30 days of planned start date of study treatment
  • Patients with gastrointestinal abnormalities that may limit absorption
  • Patients with significant cardiovascular disease
  • Patients undergoing serial blood counts to achieve a value to meet eligibility
  • Patients receiving blood product transfusions in order to meet eligibility criteria

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Dr. Allan Covens, MD contact

416-480-4026

al.covens@sunnybrook.ca

Canada1 site, 1 recruiting

  • Sunnybrook Research Institute

    Toronto, Ontario, M4N3M5

    Nithla Mohanathas, nithla.mohanathas@sunnybrook.ca

    Dr. Allan Covens, MD

    Recruiting

Other trials in Canada

About this study

Official title: A Phase II, Single-Arm Trial Assessing Alternative Dosing Of Niraparib To Decrease Dose Interruption In First Line Maintenance Treatment For Ovarian Cancer: Dose Escalation

The goal of this clinical trial is to test alternative dosing of niraparib in patients with newly diagnosed high-grade, advanced stage ovarian cancer. The main questions it aims to answer are:

What is the incidence of hematologic and other adverse events? What is the incidence of dose interruption, dose reduction and discontinuation? What is the length of time of progression-free survival at 24 months?

Read the detailed description

This is a single arm phase II study in patients with newly diagnosed high-grade, advanced stage ovarian cancer. Patients must have received a minimum of 4 cycles of front-line platinum-based chemotherapy with a complete response or partial response (no measurable lesion >1 cm and normal cancer antigen (CA -25) after completion of chemotherapy) and primary or interval debulking surgery. This study aims to evaluate the incidence of hematologic and other adverse events and the incidence of dose interruption, dose reduction and discontinuation, and progression-free survival at 24 months with a niraparib dose escalation design. Study enrollment is planned to include 40 patients at one site.

Being tested
Niraparib
Medical subject headings
Ovarian Neoplasms

What participants receive

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

  • NiraparibDrug

    Also called Zejula

    Niraparib (Zejula) will be administered as an oral treatment once daily (continuously in a 28-day cycle). Niraparib will be administered in a dose escalation design where patients will start at a dose of 100 mg PO daily for the first two cycles (28-days each cycle), if tolerated, the dose will be increased to 200 mg PO daily for the third and fourth cycle.

Study groups in NCT05961124
Study groupRoleWhat they receive
Single arm- NiraparibExperimentalOral niraparib will be administered in a dose escalation design where patients will start at a dose of 100 mg PO daily for the first two cycles, then 200 mg PO daily for the third and fourth cycle. Patients will remain on the individualized dose until either they experience an adverse event and require a dose reduction or they have disease progression.
Receives: Drug: Niraparib

What is being measured

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

  1. Incidence of thrombocytopenia

    Incidence of thrombocytopenia <100 x 109/L requiring a treatment interruption

    Measured: 2 years

Secondary outcomes (11)

  1. Incidence of dose reduction due to thrombocytopenia

    Measured: 2 years

  2. Incidence of discontinuation due to thrombocytopenia

    Measured: 2 years

  3. Incidence of other hematologic toxicity

    Measured: 2 years

  4. Incidence of dose reduction due to other hematologic toxicity

    Measured: 2 years

  5. Incidence of discontinuation due to other hematologic toxicity

    Measured: 2 years

  6. Incidence of other toxicities

    Measured: 2 years

  7. Incidence of dose reduction due to other toxicities

    Measured: 2 years

  8. Incidence of discontinuation due to other toxicities

    Measured: 2 years

  9. Incidence of discontinuation due to disease progression

    Measured: 2 years

  10. Incidence of discontinuation for other reasons

    Measured: 2 years

  11. Progression-free survival at 24 months

    Measured: 2 years

Timeline

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

  1. First posted27 Jul 2023
  2. Study start21 Aug 2023
  3. Primary completionSep 2025 (estimated)
  4. Study completionSep 2027 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05961124
Sponsor's protocol ID
5397
Status last verified
Aug 2023
First submitted
18 Jul 2023
Last updated
22 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Niraparib in people with Ovarian Cancer and Stage III Ovarian Cancer, run by Sunnybrook Health Sciences Centre at 1 site in Canada.

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 18 inclusion and 28 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: looking for participants now, as of the sponsor's last update on 22 Nov 2023. 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 Canada. 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?

Contact Dr. Allan Covens, MD (416-480-4026, al.covens@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of thrombocytopenia (time frame: 2 years). 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 NCT05961124.

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 22 Nov 2023.

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Clinical Trial NCT05961124 | AzTrials