Niraparib and Panitumumab in Treating Patients with Advanced or Metastatic Colorectal Cancer

Inclusion Criteria

• Participant must have advanced, metastatic RAS wildtype colorectal cancer and must have received at least one line of palliative systemic therapy. Both microsatellite (MSI-H) high and stable (MSS) patients are eligible
• Participants may have been intolerant of, progressed on, or failed at least one line of systemic chemotherapy in the metastatic setting. 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
• Participant must be >= 18 years of age
• Absolute neutrophil count >= 1,500/uL
• Platelets >= 100,000/uL
• 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 receiving corticosteroids may continue as long as their dose is stable for least 4 weeks prior to initiating protocol therapy
• 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 study treatment if of childbearing potential and agrees to abstain from activities that could result in pregnancy from screening through 180 days after the last dose of study treatment or is of nonchildbearing potential. Nonchildbearing potential is defined as follows (by other than medical reasons): * >= 45 years of age and has not had menses for > 1 year * Patients who have been amenorrhoeic for < 2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation * Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound/screening computed tomography (CT)/magnetic resonance imaging (MRI) scans. Tubal ligation must be confirmed with medical records of the actual procedure, otherwise the patient must be willing to use 2 adequate barrier methods throughout the study, starting with the screening visit through 180 days after the last dose of study treatment ** Note: Abstinence is acceptable if this is the established and preferred contraception for the patient
• Participant must agree to not breastfeed during the study or for 180 days after the last dose of study treatment
• Male participant agrees to use an adequate method of contraception starting with the first dose of study treatment through 180 days after the last dose of study treatment * Note: Abstinence is acceptable if this is the established and preferred contraception for the patient
• Participant must be able to understand the study procedures and agree to participate in the study by providing written informed consent

Exclusion Criteria

• Participant must not be simultaneously enrolled in any interventional clinical trial
• Participant must not have had major surgery =< 3 weeks prior to initiating protocol therapy and participant must have recovered from any surgical effects
• Participant must not have received investigational therapy =< 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter, prior initiating protocol therapy
• Prior therapy with poly ADP (adenosine diphosphate) ribose polymerase (PARP) inhibitors or with EGFR inhibitors approved for the treatment of colorectal cancer (cetuximab or panitumumab)
• Patients with a history of interstitial pneumonitis or pulmonary fibrosis, or evidence of interstitial pneumonitis or pulmonary fibrosis during screening
• Inability to take oral medications
• Participant has had radiation therapy encompassing > 20% of the bone marrow within 2 weeks; or any radiation therapy within 1 week prior to day 1 of protocol therapy
• Participant must not have a known hypersensitivity to components or excipients of niraparib or panitumumab
• Participant must not have received a transfusion (platelets or red blood cells) =< 4 weeks prior to initiating protocol therapy
• Participant must not have received colony stimulating factors (e.g., granulocyte colony-stimulating factor, granulocyte macrophage colony stimulating factor, or recombinant erythropoietin) within 4 weeks prior initiating protocol therapy
• Participant has had any known grade 3 or 4 anemia, neutropenia or thrombocytopenia due to prior chemotherapy that persisted > 4 weeks and was related to the most recent treatment
• Participant must not have any known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia m(AML)
• Participant must not have a serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent
• Known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies)
• Participant must not have had diagnosis, detection, or treatment of another type of cancer =< 2 years prior to initiating protocol therapy (except basal or squamous cell carcinoma of the skin and cervical cancer that has been definitively treated)
• Participant must not have known active, symptomatic brain or leptomeningeal metastases. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging [CT/MRI] for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability