Clinical Trials

The James Cancer Center Columbus, OH

open for enrollment

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

Protocol: OSU-16068

Full Title

A Phase III, 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

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).

Are you eligible?

Inclusion 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) -

Exclusion 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) -