Newton Study (NEW Dosing mainTenance Therapy Ovarian caNcer)

  • STATUS
    Recruiting
  • End date
    Dec 1, 2023
  • participants needed
    105
  • sponsor
    Mario Negri Institute for Pharmacological Research
Updated on 22 September 2021
direct bilirubin
neutrophil count
ovarian cancer
fallopian tube
niraparib
peritoneal cancer
cancer of the ovary

Summary

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

Details
Condition Ovarian disorder, Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cancer, Primary Peritoneal Carcinoma, ovarian carcinomas, cancer, ovarian, cancer ovarian, cancer of the ovary, fallopian tube cancers, ovarian tumors
Treatment Niraparib
Clinical Study IdentifierNCT03891576
SponsorMario Negri Institute for Pharmacological Research
Last Modified on22 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

18 years of age or older, female, any race
Histologically diagnosed ovarian cancer, fallopian tube cancer or primary peritoneal cancer
High grade (or grade 3) serous histology or known to have gBRCAmut
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)
Has responded to the last platinum line (PR or CR)
No more than 8 weeks have elapsed from completion of the last platinum regimen and the patient is still not progressing after response
Eastern Cooperative Oncology Group (ECOG) performance status of 1
Adequate bone marrow, kidney and liver function, defined as follows
Absolute neutrophil count 1,500/L
Platelets 100,000/L
Hemoglobin 9 g/dL
Serum creatinine 1.5 x upper limit of normal (ULN) or calculated creatinine clearance 30 mL/min using the Cockcroft-Gault equation
Total bilirubin 1.5 x ULN (2.0 in patients with known Gilberts syndrome) OR direct bilirubin 1 x ULN
Aspartate aminotransferase and alanine aminotransferase 2.5 x ULN unless liver metastases are present, in which case they must be 5 x ULN
Patient receiving corticosteroids may continue as long as their dose is stable for least 4 weeks prior to initiating protocol therapy
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
Patient must agree to not breastfeed during the study or for 180 days after the last dose of study treatment
Patient must be able to understand the study procedures and agree to participate in the study by providing written informed consent
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

Patient simultaneously enrolled in any interventional clinical trial
Invasive cancer other than ovarian cancer within 2 years (except basal or squamous cell carcinoma of the skin that has been definitely treated)
Patient with known, symptomatic brain or leptomeningeal metastases
Patient with immunocompromised status
Patient with known active hepatic disease
Prior treatment with a known PARP inhibitor
Patient who has had major surgery 3 weeks prior to initiating protocol therapy and participant must have recovered from any surgical effects
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
Patient has had radiation therapy encompassing >20% of the bone marrow within 2 weeks prior to day 1 of protocol therapy
Patient has had any radiation therapy within 1 week prior to day 1 of protocol therapy
Patient with known hypersensitivity to niraparib components or excipients
Patient has received a transfusion (platelets or red blood cells) 4 weeks prior to initiating protocol therapy
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
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
Patient with any known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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