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Trial record 1 of 1 for:    NCT02354586
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A Study of Niraparib in Patients With Ovarian Cancer Who Have Received Three or Four Previous Chemotherapy Regimens (QUADRA)

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ClinicalTrials.gov Identifier: NCT02354586
Recruitment Status : Active, not recruiting
First Posted : February 3, 2015
Last Update Posted : October 22, 2018
Sponsor:
Collaborators:
Facing Our Risk of Cancer Empowered
Myriad Genetics, Inc.
Information provided by (Responsible Party):
Tesaro, Inc.

Brief Summary:
This is a Phase 2, open-label, single arm study to evaluate the safety and efficacy of niraparib in ovarian cancer patients who have received three or four previous chemotherapy regimens. Niraparib is an orally active PARP inhibitor. Niraparib will be administered once daily continuously during a 28-day cycle. Health-related quality of life will be measured by Eastern Cooperative Oncology Group performance status (ECOG). Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), RECIST tumor assessments and safety laboratory values.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: Niraparib Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of Niraparib in Patients With Advanced, Relapsed, High-Grade Serous Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Who Have Received Three or Four Previous Chemotherapy Regimens
Study Start Date : March 2015
Actual Primary Completion Date : October 2017
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
Experimental: Niraparib Drug: Niraparib



Primary Outcome Measures :
  1. Evaluate antitumor activity of niraparib [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Evaluate durability of anti-cancer activity (i.e. time from first response, CR or PR until disease progression). [ Time Frame: 6 months ]
    The evaluation is measured by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), RECIST tumor assessments and safety laboratory values.

  2. Evaluate antitumor activity of niraparib in HRD+ and gBRCAmut [ Time Frame: 6 months ]
    To evaluate antitumor activity of niraparib in homologous recombination deficiency (HRD) positive patients and in gBRCAmut positive patients

  3. Disease Control Rate (DCR) [ Time Frame: 6 months ]
  4. Progression Free Survival [ Time Frame: 6 months ]
    Time from enrollment to the earlier date of assessment of progression by any cause in the absence of progression per RECIST (v.1.1) or clinical criteria, or death.

  5. Overall Survival [ Time Frame: 6 months ]
    Time from enrollment to the date of death by any cause.

  6. Evaluate the safety and tolerability of niraparib in ovarian cancer patients (Review of adverse events, concomitant medications, physical exams, electrocardiograms (ECGs), and safety lab values.) [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must agree to undergo tumor HRD testing and blood gBRCAmut status testing.
  • Patients of childbearing potential must have negative pregnancy serum test within 72 hours of being dosed
  • Patients must have histologically diagnosed high-grade (Grade 2 or 3) serous epithelial ovarian, fallopian tube, or primary peritoneal cancer with recurrent disease and must have been previously treated with chemotherapy and experienced a response lasting at least 6 months to first-line platinum based therapy.
  • Patients Must have completed 3 or 4 previous chemotherapy regimens.
  • Patients must have completed their last chemotherapy regimen > 4 weeks prior to treatment initiation.
  • Patients must have measurable disease according to RECIST (v.1.1).
  • Patients must have formalin-fixed, paraffin-embedded tumor samples available from the primary or recurrent cancer or agree to undergo fresh biopsy prior to study treatment initiation.
  • Patients must agree to blood samples during screening and at the end of treatment for cytogenetic analysis.

Exclusion Criteria:

  • Patients must not have any known, persistent (> 4 weeks), ≥Grade 3 hematologic toxicity during the last cancer therapy. Patients must not have any known, persistent (>4 weeks), ≥ Grade 3 fatigue during the last cancer therapy.
  • Patients must not have received pelvic radiotherapy as treatment for primary or recurrent disease within 1 year of the first dose of study treatment.
  • Patients must not have symptomatic uncontrolled brain or leptomeningeal metastases.
  • Patients must not be considered a poor medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease or active, uncontrolled infection.
  • Patients must not have received a transfusion (platelets or red blood cells) within 4 weeks of the first dose of study treatment.
  • Patients must not have known history or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02354586


  Show 49 Study Locations
Sponsors and Collaborators
Tesaro, Inc.
Facing Our Risk of Cancer Empowered
Myriad Genetics, Inc.

Responsible Party: Tesaro, Inc.
ClinicalTrials.gov Identifier: NCT02354586     History of Changes
Other Study ID Numbers: PR-30-5020-C
First Posted: February 3, 2015    Key Record Dates
Last Update Posted: October 22, 2018
Last Verified: October 2018

Keywords provided by Tesaro, Inc.:
gBRCAmut
BRCA
PARP inhibitor
HRD
Ovarian cancer
Serous Epithelial
Fallopian Tube
Primary Peritoneal

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type
Niraparib
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents