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A Study of Niraparib in Patients With Ovarian Cancer Who Have Received Three or Four Previous Chemotherapy Regimens (QUADRA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Tesaro, Inc.
Sponsor:
Collaborators:
Facing Our Risk of Cancer Empowered
Myriad Genetics, Inc.
Information provided by (Responsible Party):
Tesaro, Inc.
ClinicalTrials.gov Identifier:
NCT02354586
First received: January 23, 2015
Last updated: July 19, 2016
Last verified: July 2016
  Purpose
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 Intervention Phase
Ovarian Cancer
Drug: Niraparib
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Tesaro, Inc.:

Primary Outcome Measures:
  • Evaluate antitumor activity of niraparib [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

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

  • Evaluate antitumor activity of niraparib in HRD+ and gBRCAmut [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    To evaluate antitumor activity of niraparib in homologous recombination deficiency (HRD) positive patients and in gBRCAmut positive patients

  • Disease Control Rate (DCR) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Progression Free Survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

  • Overall Survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Time from enrollment to the date of death by any cause.

  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 250
Study Start Date: March 2015
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Niraparib Drug: Niraparib

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders 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 or fatigue from prior cancer therapy requiring treatment with transfusion or growth factors on more than 1 occasion within 1 year prior to study 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 current evidence of any condition, therapy, or laboratory abnormality (including active or uncontrolled myelosuppression [ie, anemia, leukopenia, neutropenia, thrombocytopenia]) that might confound the results of the study or interfere with the patient's participation for the full duration of the study treatment or that makes it not in the best interest of the patient to participate.
  • Patients must not have any known history of myelodysplastic syndrome (MDS) or a pretreatment cytogenetic testing result at risk for a diagnosis of MDS/acute myeloid leukemia (AML).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02354586

Contacts
Contact: Haroun Archer, MD 781-786-7057 Harcher@tesarobio.com
Contact: Beth Zaharoff 781-209-5485 Bzaharoff@tesarobio.com

  Show 48 Study Locations
Sponsors and Collaborators
Tesaro, Inc.
Facing Our Risk of Cancer Empowered
Myriad Genetics, Inc.
  More Information

Responsible Party: Tesaro, Inc.
ClinicalTrials.gov Identifier: NCT02354586     History of Changes
Other Study ID Numbers: PR-30-5020-C 
Study First Received: January 23, 2015
Last Updated: July 19, 2016
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on September 23, 2016