Brief Title
Newton Study (NEW Dosing mainTenance Therapy Ovarian caNcer)
Official Title
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
Brief Summary
This study evaluates whether the adoption of the RADAR dosing strategy could further reduce
treatment related toxicities improving the safety profile of niraparib.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Safety: Occurrence of grade ≥3 thrombocytopenia
Secondary Outcome
Safety: Occurrence of grade ≥ 3 thrombocytopenia
Condition
Ovarian Cancer
Intervention
Niraparib
Study Arms / Comparison Groups
Niraparib 200 mg
Description: Niraparib will be administered every day as oral at a fixed dose of 200 mg
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
105
Start Date
November 13, 2019
Completion Date
December 31, 2023
Primary Completion Date
December 31, 2023
Eligibility Criteria
Inclusion Criteria:
1. 18 years of age or older, female, any race
2. Histologically diagnosed ovarian cancer, fallopian tube cancer or primary peritoneal
cancer
3. High grade (or grade 3) serous histology or known to have gBRCAmut
4. Has received at least 2 previous lines of platinum-containing therapy (not necessarily
consecutive), and has disease that was considered platinum sensitive following the
penultimate platinum line (more than 6-months period between penultimate platinum
regimen and progression of disease)
5. Has responded to the last platinum line (PR or CR)
6. No more than 8 weeks have elapsed from completion of the last platinum regimen and the
patient is still not progressing after response
7. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
8. Adequate bone marrow, kidney and liver function, defined as follows:
1. Absolute neutrophil count ≥ 1,500/µL
2. Platelets ≥ 100,000/µL
3. Hemoglobin ≥ 9 g/dL
4. Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine
clearance ≥ 30 mL/min using the Cockcroft-Gault equation
5. Total bilirubin ≤ 1.5 x ULN (≤2.0 in patients with known Gilberts syndrome) OR
direct bilirubin ≤ 1 x ULN
6. Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN unless liver
metastases are present, in which case they must be ≤ 5 x ULN
9. Patient receiving corticosteroids may continue as long as their dose is stable for
least 4 weeks prior to initiating protocol therapy.
10. Patient must have a negative urine or serum pregnancy test within 7 days prior to
taking study treatment if childbearing potential and agrees to abstain from activities
that could result in pregnancy from screening through 180 days after the last dose of
study treatment or use adequate barrier methods throughout the study. Non-childbearing
potential is defined as follows (by other than medical reasons): ≥45 years of age and
has not had menses for >1 year; patients with amenorrhea for <2 years without history
of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in
the postmenopausal range upon screening evaluation; Post-hysterectomy, post-bilateral
oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be
confirmed with medical records of the actual procedure or confirmed by an ultrasound.
Tubal ligation must be confirmed with medical records, otherwise the patient must be
willing to use 2 adequate barrier methods throughout the study, starting with the
screening visit through 180 days after the last dose of study treatment.
11. Patient must agree to not breastfeed during the study or for 180 days after the last
dose of study treatment.
12. Patient must be able to understand the study procedures and agree to participate in
the study by providing written informed consent.
13. Patients must have normal blood pressure or adequately treated and controlled
hypertension. (i.e. systolic BP ≤ 140 mmHg and diastolic BP ≤ 90 mmHg)
Exclusion Criteria:
1. Patient simultaneously enrolled in any interventional clinical trial
2. Invasive cancer other than ovarian cancer within 2 years (except basal or squamous
cell carcinoma of the skin that has been definitely treated)
3. Patient with known, symptomatic brain or leptomeningeal metastases
4. Patient with immunocompromised status
5. Patient with known active hepatic disease
6. Prior treatment with a known PARP inhibitor
7. Patient who has had major surgery ≤ 3 weeks prior to initiating protocol therapy and
participant must have recovered from any surgical effects.
8. Patient who has received investigational therapy ≤ 4 weeks, or within a time interval
less than at least 5 half-lives of the investigational agent, whichever is shorter,
prior initiating protocol therapy.
9. Patient has had radiation therapy encompassing >20% of the bone marrow within 2 weeks
prior to day 1 of protocol therapy
10. Patient has had any radiation therapy within 1 week prior to day 1 of protocol
therapy.
11. Patient with known hypersensitivity to niraparib components or excipients.
12. Patient has received a transfusion (platelets or red blood cells) ≤ 4 weeks prior to
initiating protocol therapy.
13. Patient has received colony stimulating factors (e.g., granulocyte colony-stimulating
factor, granulocyte macrophage colony stimulating factor, or recombinant
erythropoietin) within 4 weeks prior initiating protocol therapy.
14. Patient has had any known Grade 3 or 4 anemia, neutropenia or thrombocytopenia due to
prior chemotherapy that persisted > 4 weeks and was related to the most recent
treatment.
15. Patient with any known history of myelodysplastic syndrome (MDS) or acute myeloid
leukemia (AML)
16. Patient with a serious, uncontrolled medical disorder. Examples include, but are not
limited to, nonmalignant systemic disease, active, uncontrolled infection,
uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial infarction,
uncontrolled major seizure disorder, unstable spinal cord compression, superior vena
cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Nicoletta Colombo, MD, +390239014650, [email protected]
Location Countries
Germany
Location Countries
Germany
Administrative Informations
NCT ID
NCT03891576
Organization ID
IRFMN-OVA-7814
Responsible Party
Sponsor
Study Sponsor
Mario Negri Institute for Pharmacological Research
Collaborators
North Eastern German Society of Gynaecological Oncology
Study Sponsor
Nicoletta Colombo, MD, Principal Investigator, Istituto Europeo di Oncologia (IEO) - Milan
Verification Date
September 2022