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PHASE II PROSPECTIVE STUDY OF NIRAPARIB IN THE SALVAGE TREATMENT OF PATIENTS WITH METASTATIC/RECURRENT/PERSISTENT UTERINE CERVICAL CARCINOMA: PROOF OF CONCEPT (Translational substudy: Evaluation of molecular markers associated with Niraparib response) - NIRACERV

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-001226-10-IT

Enrollment

Registered

2020-10-07

Start date

2020-09-29

Completion date

Unknown

Last updated

2024-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

METASTATIC/RECURRENT/PERSISTENT UTERINE CERVICAL CARCINOMA MedDRA version: 20.0 Level: LLT Classification code 10046769 Term: Uterine carcinoma System Organ Class: 100000004864

Interventions

Product Name: Niraparib Product Code: [91035] Pharmaceutical Form: Capsule, hard INN or Proposed INN: Niraparib CAS Number: 1038915-60-4 Current Sponsor code: 24958200 Concentration unit: mg milligram

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Biopsy-proven diagnosis of cervical carcinoma was required, age >18 years and 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Italy

Contacts

Public ContactDirezione Scientifica Policlinico U

Direzione Scientifica Policlinico Universitario Agostino Gemelli IRCCS

direzione.scientifica@policlinicogemelli.it0630155701

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026