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NCT Number: NCT04546373

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

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).

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Key information

Conditions

Epithelial Ovarian Cancer Adnexal Diseases Carcinoma Carcinoma, Ovarian Epithelial Endocrine Gland Neoplasms Endocrine System Diseases Fallopian Tube Cancer Fallopian Tube Diseases Fallopian Tube Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Ovarian Diseases Ovarian Neoplasms Primary Peritoneal Cancer Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Hospital Clínico Universitario de Santiago, Santiago de Compostela, A Coruña, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Niraparib

Drug

Patient's medical records will be screened by local clinical staff to assess for eligibility according to selection criteria. The study comprises a single study visit, in which the patient will give her informed consent to participate (when the patient is alive) and the physician will extract the study data from the patient's medical charts. 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).

Primary outcomes

  1. Demographics

    Time frame: Month 4-6

  2. Medical History

    Time frame: Month 4-6

  3. Ovarian Cancer Diagnosis

    Time frame: Month 4-6

  4. Ovarian Cancer Treatments (pre-Niraparib)

    Time frame: Month 4-6

  5. Baseline (pre-Niraparib)

    Time frame: Month 4-6

  6. Niraparib Treatment

    Time frame: Month 4-6

  7. Niraparib Disease Progression

    Time frame: Month 4-6

  8. Best Response Assessment

    Time frame: Month 4-6

  9. Niraparib-Related Adverse Events

    Time frame: Month 4-6

  10. Relevant Concomitant Medications

    Time frame: Month 4-6

  11. Death

    Time frame: Month 4-6

  12. Survival Status

    Time frame: Month 4-6

  13. Subsequent Therapies for Ovarian Cancer

    Time frame: Month 4-6

Sponsors and collaborators

Lead sponsor

Grupo Español de Investigación en Cáncer de Ovario

Other

Registry information

Official study title

A Retrospective, Multicenter Study of Niraparib as Maintenance Therapy in Patients With Platinum Sensitive Recurrent Ovarian Cancer Who Have Received Niraparib Within the Expanded Access Program (EAP) in Spain

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 14, 2020
Registry last updated
Aug 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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