Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 4:03 PM
Ignite Modification Date:
2025-12-26 @ 4:03 PM
NCT ID:
NCT05412706
Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent
* Age ≥ 18 years at time of study entry
* Histologically confirmed diagnosis of Stage IV colorectal adenocarcinoma
* Disease evaluation with proven Complete Response or Partial Response according to RECIST v 1.1 after 4 months of oxaliplatin-based doublets or triplets with or without anti-VEGF or anti-EGFR agents
* Availability of Formalin-Fixed Paraffin-Embedded tumor tissue
* Treatment with Niraparib must be started after at least 2 weeks the end of platinum-based induction therapy up to 6 weeks
* Eastern Cooperative Oncology Group Performance Status \< 1
* Adequate normal organ and marrow function as follow: Haemoglobin≥9.0 g/dL; b. Absolute neutrophil count ≥1.5 × 109 /L; Platelet count ≥100 × 109/L; Serum bilirubin ≤1.5 x Upper Limit of Normal This will not apply to patients with Gilbert's syndrome; Calculated creatinine CL\>40 mL/min by the Cockcroft-Gault formula; Aspartate aminotransferase /Alanine Aminotransferase ≤2.5 x Upper Limit of Normal o ≤ 5 x Upper Limit of Normal in the presence of liver metastases
* Willing and able to comply with all of the requirements and visits in the protocol
* Participant must agree not to donate blood during the study or for 90 days after the last dose of Niraparib
* Fertile women must have a negative urine or serum pregnancy test within 7 days prior to taking study treatment
* Fertile women must use highly effective contraception, starting with the screening visit through 6 months post last dose of Niraparib.
* Male participant agrees to use an adequate method of contraception starting with the first dose of study treatment through 90 days after the last dose of study treatment.
* Male participant must not donate sperm for 90 days after last dose of Niraparib.
Exclusion Criteria:
* Prior adjuvant treatment for stage II/III colorectal cancer ending within 12 months before the start of induction treatment
* Patients with Microsatellite instability high or DNA mismatch repair deficiency DSBs DNA double-strand breaks are not allowed
* Any systemic disease that, in the opinion of the Investigator, it is not compatible with the protocol
* Major surgery ≤ 3 weeks prior to initiating Niraparib
* Participation in another interventional clinical trial
* Radiation therapy encompassing \>20% of the bone marrow within 2 weeks; or any radiation therapy \< 1 week prior to taking Niraparib
* Hypersensitivity to Niraparib components or excipients
* Transfusion (platelets or red blood cells) ≤ 4 weeks prior to initiating Niraparib
* Colony stimulating factors (e.g., granulocyte colony-stimulating factor, granulocyte macrophage colony stimulating factor, or recombinant erythropoietin) within 4 weeks prior Niraparib
* Any known Grade 3 or 4 anemia, neutropenia or thrombocytopenia due to prior chemotherapy that persisted \> 4 weeks
* History of myelodysplastic syndrome, acute myeloid leukemia or Prior Reversible Encephalopathy Syndrome
* Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection.
* Diagnosis, detection, or treatment of another type of cancer ≤ 2 years prior to initiating Niraparib (except basal or squamous cell carcinoma of the skin and cervical cancer in situ that has been definitively treated)
* Active infection with Human Hepatitis B Virus or Hepatitis C Virus
* Pregnancy or breastfeeding
* Any impairment of gastrointestinal function or disease that may significantly impair the absorption of oral drugs, malabsorption syndrome, bowel obstruction, or inability to swallow tablets).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05412706
Study Brief:
Protocol Section:
NCT05412706