Niraparib as Maintenance Therapy in Patients With Platinum Sensitive Recurrent Ovarian Cancer

Completed

• Conditions: Epithelial Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer

• Registration Number: NCT04546373
• Lead Sponsor: Grupo Español de Investigación en Cáncer de Ovario

Brief Summary

In April 2017, Tesaro, Inc. opened an expanded access program (EAP) to make niraparib, an investigational poly (ADP-ribose) polymerase (PARP) inhibitor, available to eligible women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer following a complete or partial response to platinum-based chemotherapy, mainly for BRCA wild-type (BRCAwt) tumor patients, a clear unmet medical need for these ovarian cancer patients. As of 19 August 2019, the EAP closing date, there were 446 patients enrolled in 105 Spanish sites.

All eligible deceased and consenting living patients at the participating centers will be included. Data will be directly retrieved from hospital medical records and reported in the electronic Case Report Form (eCRF).

This study seeks to evaluate the safety profile and dose adjustments of niraparib in platinum sensitive recurrent ovarian cancer patients treated in a real world setting within the Spanish expanded access program (EAP).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-02
• Study First Submitted QC: 2020-09-07
• Study First Posted: 2020-09-14
• Study Start: 2020-09-30
• Primary Completion: 2021-07-31
• Study Completion: 2021-07-31
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-04
• Last Update Posted: 2021-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 316

Inclusion Criteria

• Female participants 18 years old or older.

• Participant must be able to understand the study procedures and agree to participate in the study by providing written informed consent.

• Participant must have received niraparib within the Spanish expanded access program (EAP).

• Patients must have received at least 1 week of treatment with niraparib.

• Histological diagnosis of high grade serous ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.

• Participants must have completed at least 2 previous courses of platinum-containing therapy (e.g., carboplatin, oxaliplatin, or cisplatin).

• For the penultimate (next to last) platinum-based chemotherapy course prior to enrolment on the program the patient must have platinum sensitive disease after this treatment; defined as achieving a response (complete response (CR) or partial response (PR)) and disease progression occurring no sooner than 6 months, after completion of the last dose of platinum chemotherapy.

• For the last chemotherapy course prior to inclusion in the program the patient must have received a platinum-containing regimen for a minimum of 4 cycles.

• For the last chemotherapy course prior to inclusion in the program the Patient must have achieved a partial (PR) or complete (CR) tumor response.

• The last platinum regimen does not necessarily have to immediately follow the next to last (penultimate) platinum regimen. For example, if a patient received a non-platinum regimen between the penultimate platinum regimen and last platinum regimen, they could be eligible, so long as they meet all entry criteria.

• When entering the EAP, patients must have met the following:

  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  • Adequate organ function - Absolute neutrophil count (ANC) ≥ (greater than or equal to) 1,500/μL.
  • Adequate organ function - Platelets ≥ (greater than or equal to) 100,000/μL.
  • Adequate organ function - Hemoglobin ≥ (greater than or equal to) 9 g/dL.
  • No transfusions of erythrocytes or platelets within 2 weeks prior to assessing adequate hematological blood counts as listed above.

Exclusion Criteria

• Patients without medical record available (lost, empty or unretrievable clinical information).
• Patients who decline consent.
• Patients who are deceased with prior express order to preserve their data.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Demographics	Month 4-6
Medical History	Month 4-6
Ovarian Cancer Diagnosis	Month 4-6
Ovarian Cancer Treatments (pre-Niraparib)	Month 4-6
Baseline (pre-Niraparib)	Month 4-6
Niraparib Treatment	Month 4-6
Niraparib Disease Progression	Month 4-6
Best Response Assessment	Month 4-6
Niraparib-Related Adverse Events	Month 4-6
Relevant Concomitant Medications	Month 4-6
Death	Month 4-6
Survival Status	Month 4-6
Subsequent Therapies for Ovarian Cancer	Month 4-6

Trial Locations

Locations (57)

Hospital Clínico Universitario de Santiago; 🇪🇸 Santiago De Compostela, A Coruña, Spain

Hospital Virgen de los Lirios; 🇪🇸 Alcoy, Alicante, Spain

Hospital Marina Baixa; 🇪🇸 Villajoyosa, Alicante, Spain

Hospital Universitario Central de Asturias; 🇪🇸 Oviedo, Asturias, Spain

Institut Català d'Oncología Badalona; 🇪🇸 Badalona, Barcelona, Spain

Hospital General de Granollers; 🇪🇸 Granollers, Barcelona, Spain

Institut Català d´ Oncologia-Hospital Duran y Reynals; 🇪🇸 L'Hospitalet De Llobregat, Barcelona, Spain

Consorci Sanitari de Terrassa; 🇪🇸 Rubí, Barcelona, Spain

Consorci Corporació Sanitària Parc Taulí de Sabadell; 🇪🇸 Sabadell, Barcelona, Spain

Hospital Universitario de Galdakao; 🇪🇸 Galdakao, Bizkaia, Spain

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