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Tesaro 3000-03-005 (FIRST): A randomized, double-blind, phase 3 comparison of platinum-based therapy with TSR-042 and niraparib versus standard of care platinum-based therapy as first-line treatment of stage III or IV non-mucinous epithelial ovarian cancer

Description

This is a global, multi-center, randomized, double-blind, controlled phase 3 study in patients with newly diagnosed, stage III or IV non-mucinous epithelial ovarian, fallopian tube, or peritoneal cancer (collectively referred to as ovarian cancer). The currently recommended standard of care therapy for the first line treatment of stage III or IV ovarian cancer is the combination of paclitaxel and carboplatin, with or without concurrent and maintenance bevacizumab.

Status

Accepting new patients

Primary Study Objective(s)

The objective of this study is to compare the progression free survival of patients with stage III or IV non-mucinous epithelial ovarian cancer treated with platinum-based therapy, TSR-042, and niraparib to standard of care platinum-based therapy as first-line treatment. Progression-free survival is defined as the time from treatment randomization to the earlier date of assessment of progression or death by any cause in the absence of progression.

Core eligibility

Note: This is only a partial list of eligibility criteria.

Including patients who:

  • Have a histologically confirmed diagnosis of high-grade, non-mucinous, epithelial ovarian cancer (serous, endometrial, clear cell, carcinosarcoma, and mixed pathologies) that is stage III or IV according to the International Federation of Gynecology and Obstetrics (FIGO) or tumor, node and metastasis staging criteria
  • Have stage IV disease, including those with inoperable disease, have undergone primary debulking surgery (complete cytoreduction or macroscopic disease), or for whom neoadjuvant chemotherapy is planned
  • Have stage III disease if they meet one or more of the following criteria:
    • Have high-risk stage IIIC disease
    • Are planning to receive neoadjuvant chemotherapy
    • Provide a blood sample for research at screening
    • Provide a formalin-fixed paraffin embedded tumor tissue sample for research at screening
  • Have adequate organ function (A complete blood count test should be obtained without transfusion or receipt of stimulating factors within two weeks before obtaining screening blood sample.)
  • Have an ECOG score of 0 or 1
  • Have normal blood pressure or adequately treated and controlled hypertension (systolic BP ≤140 mmHg and/or diastolic BP ≤90 mmHg)
  • Agree to complete HRQoL questionnaires throughout the study
  • Are able to take oral medication

Excluding patients who:

  • Have mucinous, germ cell, transitional cell, or undifferentiated tumor
  • Have low-grade or grade I epithelial ovarian cancer
  • Have stage III disease and have had complete cytoreduction resection after primary debulking surgery
  • Have not adequately recovered from prior major surgery
  • Have a known condition, therapy, or laboratory abnormality that might confound the study results or interfere with the patient's participation for the full duration of the study treatment in the opinion of the investigator
  • Have been diagnosed and/or treated with any therapy for invasive cancer less than five years from study enrollment, completed adjuvant chemotherapy and/or targeted therapy, such as trastuzumab, less than three years from enrollment, or completed adjuvant hormonal therapy less than four weeks from enrollment (Patients with definitively treated non-invasive malignancies such as cervical carcinoma in situ, ductal carcinoma in situ, grade I or II, stage IA endometrial cancer, or non-melanomatous skin cancer are allowed.)
  • Have an increased bleeding risk due to concurrent conditions, such as major injuries or major surgery within the past 28 days prior to start of study treatment and/or history of hemorrhagic stroke, transient ischemic attack, subarachnoid hemorrhage, or clinically significant hemorrhage within the past 3 months
  • Are immunocompromised (Patients with splenectomy are allowed. Patients with well-controlled known human immunodeficiency virus (HIV) are allowed.)
  • Have known active hepatitis B or hepatitis C
  • Are considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease, or active, uncontrolled infection
  • Have had investigational therapy administered within four weeks or within a time interval less than at least five half-lives of the investigational agent, whichever is longer, prior to the first scheduled day of dosing in this study
  • Have received a live vaccine within 14 days of planned start of study therapy. (Seasonal influenza vaccines that do not contain live viruses are allowed.)
  • Have a known contraindication or uncontrolled hypersensitivity to the components of paclitaxel, carboplatin, niraparib, bevacizumab, TSR-042, or their excipients
Learn more about ovarian cancer
     

Accepting new patients

 

Learn more at

clinicaltrials.gov

 

Principal Investigator(s)

Julian Schink