Neoplasms

All Conditions

Blood and Lymph Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Immune System Diseases

Rare Diseases

Carcinoma

Thrombocytopenia

Recurrence

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Anemia

Hypersensitivity

Neutropenia

Fallopian Tube Neoplasms

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Fallopian Tube Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Granulocytopenia

Fallopian Tube Cancer

Antineoplastic Agents

All Drugs and Chemicals

Niraparib

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

Niraparib will be administered every day as oral at a fixed dose of 200 mg

Niraparib will be administered every day as oral at a fixed dose of 300 mg

Niraparib will be administered every day as oral at a fixed dose of 200 mg or 300 mg

Niraparib is a potent, orally active PARP1 and PARP2 inhibitor being developed as a treatment for patients with tumors that harbor defects in the homologous recombination DNA repair pathway or that are driven by PARP-mediated transcription factors.

Nicoletta Colombo, MD

This study evaluates whether the adoption of the RADAR dosing strategy could further reduce treatment related toxicities improving the safety profile of niraparib.

This is a study built up by a randomized and a no-randomized part.

Randomized part:

Patients who either have a baseline body weight ≥58 and \<77kg, or have a baseline body weight ≥77kg and baseline platelet count \<150,000/µL (named as restricted population) will be randomly assigned to receive RADAR dosing or the SmPC dosing.

Randomization ratio will be 1:1 and will be based on a minimization procedure accounting for the following factors: i. platinum sensitivity; ii. use of bevacizumab in conjunction with the penultimate platinum based therapy; iii. best response (complete or partial) during the last platinum regimen.

No-randomized part:

Patients with weight \<58 or ≥77kg and baseline platelet count ≥150,000/µL will be enrolled into the study but not randomized.

Newton Study (NEW Dosing mainTenance Therapy Ovarian caNcer)

A Multicenter, Open-label Phase II Trial of a New Customized Dosing (RADAR Dosing) of Niraparib as Maintenance Therapy in Platinum Sensitive Ovarian, Fallopian Tube or Primary Peritoneal Recurrent Cancer Patients

Rate of patients experiencing a grade ≥3 thrombocytopenia during the first three cycles

Rate of patients experiencing a grade ≥3 thrombocytopenia during the first six cycles

Maximum toxicity grade experienced by each patient, for each toxicity, according to NCI-CTCAE v. 4.03

Patient experiencing grade 3-4 for each toxicity

PFS rate at 6 months, defines as the proportion of patients alive and free from progression at 6 months after randomization

PFS, defined as the time from the date of treatment randomization to the date of first documentation of progression or death whichever occurs first

OS at 24 months, defined as the rate of patients who are alive at 24 months from randomization

Trough level of niraparib concentration at steady state (Css) and peak level at 2 hours after dosing

Frequency and reasons for drug discontinuation and treatment modification

Spots Global Cancer Trial Database for platinum senitive