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New treatment option for Ovarian Cancer
Official title A Phase II Randomized, Open Label Non-inferiority Study of NiraParib Maintenance After 3 vs. 6 Cycles of Platinum-based Chemotherapy in completeLy debUlked Advanced HRDpositive High-grade Ovarian Cancer patientS in First Line Therapy
ClinicalTrials.gov ID: NCT05460000
What this study is testing
What is 3 cycles chemotherapy instead of 6 cycles chemotherapy?
3 cycles chemotherapy instead of 6 cycles chemotherapy is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for ovarian cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Multicenter, randomized, open label study including patients with advanced HRDpositive high-grade ovarian cancer, fallopian tube cancer, primary peritoneal cancer and clear cell carcinoma of the ovary with no residual tumor mass following primary tumor debulking to determine recurrence free survival in patients treated with 3 cycles carboplatin + paclitaxel and maintenance therapy with niraparib vs. 6 cycles carboplatin + paclitaxel and maintenance therapy with niraparib.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Written informed consent and obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.
- Female patient, age ≥ 18 years.
- FIGO Stage III-IV high-grade ovarian cancer (all histological types, except mucinous histology)
- Complete primary debulked patients (without any macroscopic residuals), confirmed by CT-Scan postoperatively.
- Patients must have formalin-fixed, paraffin-embedded tumor samples available from the primary cancer for central NGS analysis and must be HRDpositive...
You likely can't join if
- Non-epithelial origin of the ovary, the fallopian tube or the peritoneum (i.e., germ cell tumors) and Ovarian tumors of low malignant potential...
- Low-grade ovarian, fallopian tube or peritoneal cancer.
- Has known hypersensitivity to any of the study drugs or any of the excipients of any of the study drugs.
- Has known hypersensitivity to platin-containing compounds other than carboplatin.
- Patients posttransplant, including previous allogeneic bone marrow transplant.
- Has undergone interval debulking of the tumor.
See the full eligibility criteria
Who can join
- Written informed consent and obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.
- Female patient, age ≥ 18 years.
- FIGO Stage III-IV high-grade ovarian cancer (all histological types, except mucinous histology)
- Complete primary debulked patients (without any macroscopic residuals), confirmed by CT-Scan postoperatively.
- Patients must have formalin-fixed, paraffin-embedded tumor samples available from the primary cancer for central NGS analysis and must be HRDpositive defined as BRCAmut independent of NOGGO GIS Score OR NOGGO GIS Score...
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Patients must be able to take oral medications.
- Synchronous and secondary malignancies are allowed if the prognosis of the ovarian cancer is not affected. The investigator must contact the medical monitoring team before enrolling the patient in the clinical trial.
- Patients must have normal organ and bone marrow function:
- Hemoglobin ≥ 10.0 g/dL independent of transfusion ≤ 14 days prior to screening hemoglobin assessment
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
- Platelet count ≥ 100 x 109/L
- Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN); \< 2 × ULN if hyperbilirubinemia is due to Gilbert's syndrome
- Aspartate aminotransferase /Serum Glutamic Oxaloacetic Transaminase (ASAT/SGOT)) and Alanine aminotransferase /Serum Glutamic Pyruvate Transaminase (ALAT/SGPT)) ≤ 2,5 x ULN
- Serum creatinine ≤ 1.5 x institutional ULN and creatinine clearance \> 30 mL/min.
- Postmenopausal or evidence of non-childbearing status for women of childbearing potential prior to the first dose of study treatment. Female patients of childbearing potential must have a negative serum pregnancy test...
- Considered to be permanently sterile. Permanent sterilization includes hysterectomy, bilateral salpingectomy, and/or bilateral oophorectomy; or
- Is postmenopausal, defined as no menses for at least 12 months without an alternative medical cause. A high follicle-stimulating hormone (FSH) level consistently in the postmenopausal range (30 mIU/mL or higher) may be...
What rules you out
- Non-epithelial origin of the ovary, the fallopian tube or the peritoneum (i.e., germ cell tumors) and Ovarian tumors of low malignant potential (e.g., borderline tumors), or mucinous carcinoma of the ovary.
- Low-grade ovarian, fallopian tube or peritoneal cancer.
- Has known hypersensitivity to any of the study drugs or any of the excipients of any of the study drugs.
- Has known hypersensitivity to platin-containing compounds other than carboplatin.
- Patients posttransplant, including previous allogeneic bone marrow transplant.
- Has undergone interval debulking of the tumor.
- Has received any anti-cancer therapy for ovarian cancer other than primary surgery.
- Administration of other simultaneous chemotherapy drugs, any other anti-cancer therapy or anti-neoplastic hormonal therapy, or simultaneous radiotherapy during the trial treatment period (hormonal replacement therapy is...
- Has received prior treatment with a PARP inhibitor or has participated in a trial where any treatment arm included the administration of a PARP inhibitor.
- Bevacizumab is planned to be given together with first line chemotherapy or as maintenance.
- Clinically significant cardiovascular disease:
- Cerebrovascular accident or myocardial infarction or unstable angina ≤6 months before start of study treatment
- Severe cardiac arrhythmia (recent event or active or uncontrolled)
- New York Heart Association grade ≥2 congestive heart failure
- Uncontrolled hypertension (defined as systolic blood pressure \>140 mmHg and/or diastolic blood pressure \>90 mmHg), or history of hypertensive crisis, or hypertensive encephalopathy or posterior reversible...
- History of stroke or transient ischemic attack ≤6 months before start of study treatment
- Coronary/peripheral artery bypass graft ≤6 months before start of study treatment
- Deep vein thrombosis or thromboembolic events ≤1 month before start of study treatment
- History or evidence of brain metastases or spinal cord compression.
- Known history of MDS or a pre-treatment cytogenetic testing result at risk for a diagnosis of MDS/AML.
- Current, clinically relevant bowel obstruction at the time of randomization.
- Patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
- Pregnant or lactating women, women of child-bearing potential who do not agree to the usage of highly effective contraception methods (see inclusion criteria) starting with the screening visit through at least 6 months...
- Participation in another clinical study with an investigational product immediately prior to randomization. Earliest time point for randomization is after the time required for the investigational product to undergo 5...
- Has a known history of Human Immunodeficiency Virus (HIV) infection (known HIV1/HIV2 antibodies positive) or acquired immunodeficiency syndrome (AIDS) related illness.
- Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] has been detected) infection.
- Has active infection with SARS-CoV-2 (antigen test).
- Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of chemotherapy treatment and while and 28 days after the last dose of trial treatment. Examples of live vaccines include...
- Patient has contraindications listed in the most recent SmPC.
- Patient who might be dependent on the sponsor, CRO, site or the investigator. 22\. In Germany: Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities § 40a S. 1 Nr. 2...
The study team makes the final eligibility decision.
Where it's taking place
- Innsbruck, Austria
- Brussels, Belgium
- Ghent, Belgium
- Hasselt, Belgium
- Leuven, Belgium
- Ostrava, Czechia
- Prague, Czechia
- Aachen, Germany
- Baden-Baden, Germany
- Berlin, Germany
- Bonn, Germany
- Detmold, Germany
- Dresden, Germany
- Düsseldorf, Germany
- Freiburg im Breisgau, Germany
- Göttingen, Germany
- Hamburg, Germany
- Heilbronn, Germany
- Kiel, Germany
- Leipzig, Germany
+ 21 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Innsbruck, Austria; Brussels, Belgium; Ghent, Belgium; Hasselt, Belgium; Leuven, Belgium; Ostrava, Czechia and 35 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.