Status:
WITHDRAWN
Niraparib Maintenance Treatment in mCRC With a Partial o Complete Response After Oxaliplatin-based Induction Therapy
Lead Sponsor:
Ospedale Policlinico San Martino
Collaborating Sponsors:
CRO "Centro Clinical Trials" IRCCS Ospedale Policlinico San Martino
Laboratory Molecular Oncology Candiolo Cancer Institute IRCCS - Candiolo (Torino)
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Colorectal Cancer ranks third among the most frequent malignancies representing a leading cause of cancer-related death worldwide. The constant improvement in the "continuum of care" of metastatic col...
Detailed Description
Multicenter phase II no profit study investigating the disease-free survival efficacy of niraparib as maintenance treatment in 46 patients with metastatic colorectal cancer with partial or complete re...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
September 4 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 4 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05412706
Start Date
September 4 2023
End Date
September 4 2023
Last Update
September 8 2023
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