a
- Conditions
- METASTATIC/RECURRENT/PERSISTENT UTERINE CERVICAL CARCINOMAMedDRA version: 20.0Level: LLTClassification code 10046769Term: Uterine carcinomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2019-001226-10-IT
- Lead Sponsor
- FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 42
Biopsy-proven diagnosis of cervical carcinoma was required, age >18 years and < 75 years, Eastern Cooperative Oncology Group (ECOG) performance status =2, presence of measurable disease, life expectancy >3 months, only 1 platinum based therapy (with or without bevacizumab) as first treatment of metastatic disease or recurrence or persistence of disease, absolute neutrophil count (ANC) >1,500/mm3; platelets count >100,000/ mm3; bilirubin and creatinine levels less than 1.5 times the upper limit of normal.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 38
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4
Patients with recurrent disease were excluded if they were candidates for curative therapy by means of pelvic exenteration, previous or concomitant malignant disease (with the exception of cutaneous basalioma if adequately treated), active neurologic or psychiatric disease.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objective of this prospective clinical Phase II study is the evaluation of activity and safety of Niraparib in the salvage treatment of metastatic/persistent/recurrent uterine cervical cancer patients.;Secondary Objective: The secondary end-points are: treatment-related toxicity, assessment of quality of life, progression-free survival (PFS), defined as the time interval from the beginning of treatment to the documented radiologic progression or the date last seen, and overall survival (OS) defined as the time interval from the first drug administration to death or date last seen.;Primary end point(s): Assessment of objective response rate (ORR).;Timepoint(s) of evaluation of this end point: 8 weeks for the first 2 cycles and 12 weeks by the third cycle
- Secondary Outcome Measures
Name Time Method