Niraparib and Panitumumab in Patients With Advanced or Metastatic Colorectal Cancer

Program Status

Active, not recruiting

Phase

Phase 2

Prior Immunotherapy Allowed

Yes

CRC-directed Trial

Yes

Drugs

Niraparib, panitumumab, Vectibix, Zejula

Tags

MSS/ MMRp

Comments

No-immunotherapy combination trial for MSS and MSI-H.Only KRAS wild patients, who had not anti EGFR yet. Two FDA approved agents:
Niraparib: PARP inhibitor, oral (Zejula)
Panitumumab: EGFR inhibitor (Vectibix)
Key inclusion/exclusion criteria:
-At least one prior line of systemic chemotherapy.
-Patients who are currently on first line (Folfox) 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.
– Not prior PARP inhibitors or EGFR inhibitors (cetuximab, panitumumab) allowed.
– No mention of measurable disease as requisite for inclusion.

Location Location Status
United States
Emory University Hospital Midtown
Atlanta, Georgia 30308
Active, not recruiting
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia 30322
Active, not recruiting
Emory Saint Joseph's Hospital
Atlanta, Georgia 30342
Active, not recruiting

Inclusion Criteria

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 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
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
Participant must be able to provide written informed consent

Exclusion Criteria

Exclusion Criteria:

Participant must not be simultaneously enrolled in any interventional clinical trial
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 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.

NCT ID

NCT03983993

Date Trial Added

2019-06-12

Updated Date

2023-05-03