This study evaluates whether the adoption of the RADAR dosing strategy could further reduce treatment related toxicities improving the safety profile of niraparib.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
83
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.
Charité - Universitätsmedizin Berlin
Berlin, Germany
University Hospital Dresden
Dresden, Germany
Kliniken Essen Mitte
Essen, Germany
Safety: Occurrence of grade ≥3 thrombocytopenia
Rate of patients experiencing a grade ≥3 thrombocytopenia during the first three cycles
Time frame: 3 months
Safety: Occurrence of grade ≥ 3 thrombocytopenia
Rate of patients experiencing a grade ≥3 thrombocytopenia during the first six cycles
Time frame: 6 months
Safety: Maximum toxicity grade
Maximum toxicity grade experienced by each patient, for each toxicity, according to NCI-CTCAE v. 4.03
Time frame: Up to two years after the last patient enrolled
Safety: Grade 3-4 toxicities
Patient experiencing grade 3-4 for each toxicity
Time frame: Up to two years after the last patient enrolled
Safety: SAE
Type, frequency and nature of SAEs
Time frame: Up to two years after the last patient enrolled
Safety: Number of patients with at least a SAE
Number of patients with at least a SAE
Time frame: Up to two years after the last patient enrolled
Safety: Number of patients with at least a SADR
Number of patients with at least a SADR
Time frame: Up two years after last patient enrolled
Safety: Number of patients with at least a SUSAR
Number of patients with at least a SUSAR
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ASST degli Spedali Civili di Brescia
Brescia, Italy
Istituto Europeo di Oncologia
Milan, Italy
Istituto Nazionale dei Tumori
Milan, Italy
Ospedale San Gerardo
Monza, Italy
Istituto Oncologico Veneto (IOV)
Padua, Italy
AO Arcispedale Santa Maria Nuova
Reggio Emilia, Italy
Policlinico Umberto I, Università di Roma "La Sapienza"
Roma, Italy
...and 2 more locations
Time frame: Up two years after last patient enrolled
Efficacy: PFS-6
PFS rate at 6 months, defines as the proportion of patients alive and free from progression at 6 months after randomization
Time frame: 6 months
Efficacy: PFS
PFS, defined as the time from the date of treatment randomization to the date of first documentation of progression or death whichever occurs first
Time frame: Up two years after last patient enrolled
Efficacy: OS
OS at 24 months, defined as the rate of patients who are alive at 24 months from randomization
Time frame: Up two years after last patient enrolled
Pharmacokinetic
Trough level of niraparib concentration at steady state (Css) and peak level at 2 hours after dosing
Time frame: Up to two years after the last patient enrolled
Compliance
Number of administered cycles
Time frame: Up to two years after the last patient enrolled
Compliance
Frequency and reasons for drug discontinuation and treatment modification
Time frame: Up to two years after the last patient enrolled
Compliance
Dose intensity
Time frame: Up to two years after the last patient enrolled