Niraparib and Panitumumab in Patients With Advanced or Metastatic Colorectal Cancer (NCT03983993) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Niraparib and Panitumumab in Patients With Advanced or Metastatic Colorectal Cancer
United States26 participantsStarted 2019-10-15
Plain-language summary
This phase II trial studies the side effects and how well niraparib and panitumumab work in treating patients with colorectal cancer that has spread to other places in the body. Niraparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as panitumumab, may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Giving niraparib and panitumumab may work better in treating patients with colorectal cancer.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participant must have advanced, metastatic RAS wildtype colorectal cancer and must have received at least one line of systemic therapy. Both microsatellite (MSI) high and stable (MSS) patients are eligible
* Participants may have been intolerant of, progressed on, or failed at least one line of systemic chemotherapy. Patients who are currently on first line Oxaliplatin-containing chemotherapy regimen are allowed on the trial if they have remained stable or better (\[partial response\]PR or \[complete response\]CR) for at least 4 months on that line of treatment and are being considered for maintenance therapy as standard of care
* Histologic or cytologic diagnosis of colorectal cancer
* Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
* Absolute neutrophil count ≥ 1,500/µL
* Platelets ≥ 100,000/µL
* Hemoglobin ≥ 9 g/dL
* Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 30 mL/min using the Cockcroft-Gault equation
* Total bilirubin ≤ 1.5 x ULN (≤ 2.0 in patients with known Gilberts syndrome) OR direct bilirubin ≤ 1 x ULN
* Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN unless liver metastases are present, in which case they must be ≤ 5 x ULN
* Participant must agree to not donate blood during the study or for 90 days after the last dose of study treatment
* Female participant has a negative urine or serum pregnancy test within 7 days prior to taking …