Trial record 12 of 24 for:    parp inhibitor ovarian | Open Studies

A Study of Niraparib Maintenance Treatment in Patients With HRD-Positive Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by Tesaro, Inc.
Sponsor:
Collaborators:
Gynecologic Oncology Group
European Network of Gynaecological Oncological Trial Group (ENGOT)
Myriad Genetics, Inc.
Information provided by (Responsible Party):
Tesaro, Inc.
ClinicalTrials.gov Identifier:
NCT02655016
First received: December 8, 2015
Last updated: July 13, 2016
Last verified: April 2016
  Purpose
This study is a double-blind, randomized (2:1 niraparib:placebo), placebo-controlled study in patients with ovarian cancer who have HRD-positive tumors, as identified with a centralized HRD test, and are at high risk for progressive disease (PD), as identified by the stage of cancer and previous response to surgery. Patients must have received at least 4 cycles of a front-line platinum-based regimen with a physician-assessed response of CR or PR (no measurable lesion >2 cm). Additionally, patients must have a normal or >90% decrease in cancer antigen 125 (CA-125) following front-line platinum treatment. The study will assess whether maintenance treatment with niraparib will extend PFS in this population. Stratification factors will include best response during the front-line platinum regimen (CRand PR).

Condition Intervention Phase
Ovarian Cancer
Drug: Niraparib
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Niraparib Maintenance Treatment in Patients With HRD-Positive Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy

Resource links provided by NLM:


Further study details as provided by Tesaro, Inc.:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first - Approximately 10 months ] [ Designated as safety issue: No ]
    The time from treatment randomization to the earlier date of assessment of progression or death by any cause in the absence of progression.


Secondary Outcome Measures:
  • Overall Survival [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
    From date of randomization until the date of first documented progression or date of death from any cause, whichever came first.

  • Safety and tolerability of Niraparib versus Placebo as Number of participants with treatment-related adverse events as assessed by CTCAE v4.0. [ Time Frame: Approximately 36 months ] [ Designated as safety issue: Yes ]
    From date of screening until the date of study discontinuation or date of death from any cause, whichever came first

  • Patient Reported Outcomes (PROs) [ Time Frame: PROs are administered from screening until 12 weeks post study discontinuation or death from any cause. Approximately 36 months ] [ Designated as safety issue: No ]
  • Time to progression on the next anticancer therapy (PFS2) [ Time Frame: Approximately 36 months ] [ Designated as safety issue: No ]
    From date of start of next anticancer therapy to date of first documented progression of date of death from any cause, whichever comes first.


Other Outcome Measures:
  • AUC0-last [ Time Frame: Up to 32 weeks ] [ Designated as safety issue: Yes ]
    AUC Area Under the Curve, time from 0 to the last quantifiable concentration

  • AUC [ Time Frame: Up to 32 weeks ] [ Designated as safety issue: Yes ]
    AUC Area Under the Curve, time from 0 to the last quantifiable concentration

  • Peak Plasma Concentration (Cmax) [ Time Frame: Up to 32 weeks ] [ Designated as safety issue: Yes ]
    Cmax Observed maximum plasma concentration

  • BRCA Diagnostic Test [ Time Frame: Samples for BRCA and HRD diagnostic testing will be obtained at screening and tested during the study. Additional biomarkers may be tested from an optional tumor sample if available at study treatment discontinuation, approximately 56months. ] [ Designated as safety issue: No ]
  • HRD Diagnostic Test [ Time Frame: Samples for BRCA and HRD diagnostic testing will be obtained at screening and tested during the study. Additional biomarkers may be tested from an optional tumor sample if available at study treatment discontinuation, approximately 56 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 305
Study Start Date: April 2016
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Niraparib
Administered once daily continuously during a 28 day cycle.
Drug: Niraparib
Niraparib vs Placebo 2:1 ratio
Placebo Comparator: Placebo
Administered once daily continuously over a 28 day cycle
Drug: Placebo

  Eligibility

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

Main Inclusion Criteria:

  1. Patients must be able to understand the study procedures and agree to participate in the study by providing written informed consent.
  2. Patients must be female ≥18 years of age
  3. Patients must have histologically diagnosed ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that is Stage III or IV according to FIGO criteria Stage III patients who have undergone debulking surgery must have had residual disease after debulking surgery unless the patient has undergone neoadjuvant therapy
  4. Patients must meet the following front-line therapy requirements:

    • Patients must have had at least 4 cycles of platinum-based (eg, carboplatin, oxaliplatin, or cisplatin) therapy
    • Patients must have achieved a complete or partial (no measurable lesion >2 cm) tumor response to platinum-based regimen per RECIST criteria
    • Patients must have either CA-125 in the normal range or CA-125 decrease by more than 90% during their front-line therapy
  5. Patients must agree to undergo HRD testing This test result must show that patients have an HRD-positive tumor
  6. Patients of childbearing potential must have a negative serum pregnancy test (beta human chorionic gonadotropin [hCG]) within 72 hours prior to receiving the first dose of study treatment
  7. Patients must be postmenopausal, free from menses for >1 year, surgically sterilized, willing to use adequate contraception to prevent pregnancy, or agree to abstain from activities that could result in pregnancy -

Main Exclusion Criteria:

  1. Patients must not be pregnant, breastfeeding, or expecting to conceive children while receiving study treatment and for 3 months after the last dose of study treatment
  2. Patients must not have a known hypersensitivity to the components of niraparib or the excipients
  3. Patients must not be simultaneously enrolled in any clinical trial of niraparib or any other investigational therapy
  4. Patients must not have received prior treatment with a known PARP inhibitor or have participated in a study where any treatment arm included administration of a known PARP inhibitor
  5. Patients must not have had investigational therapy administered within 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is longer, prior to the first scheduled day of dosing in this study
  6. Patients must not have had any known, persistent (>4 weeks), ≥Grade 3 hematological toxicity or fatigue from prior cancer therapy
  7. Patients must not have any known history of myelodysplastic syndrome (MDS) or a pre-treatment 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: NCT02655016

Contacts
Contact: Romnee Clark, MD 781-257-2383 rclark@tesarobio.com
Contact: Beth Zaharoff 781- 209-5485 bzaharoff@tesarobio.com

Locations
United States, Louisiana
Recruiting
Covington, Louisiana, United States
United States, New York
Recruiting
Mineola, New York, United States
United States, Ohio
Recruiting
Columbus, Ohio, United States
United States, Oklahoma
Recruiting
Tulsa, Oklahoma, United States
United States, South Dakota
Recruiting
Sioux Falls, South Dakota, United States
Sponsors and Collaborators
Tesaro, Inc.
Gynecologic Oncology Group
European Network of Gynaecological Oncological Trial Group (ENGOT)
Myriad Genetics, Inc.
  More Information

Responsible Party: Tesaro, Inc.
ClinicalTrials.gov Identifier: NCT02655016     History of Changes
Other Study ID Numbers: PR-30-5017-C 
Study First Received: December 8, 2015
Last Updated: July 13, 2016
Health Authority: United States: Food and Drug Administration
EU: EMA

Keywords provided by Tesaro, Inc.:
Ovarian Cancer
PARP Inhibitor
HRD
HRD positive
PRIMA
PRIMA Clinical Trial
PRIMA Study

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

ClinicalTrials.gov processed this record on July 27, 2016