Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Study of IMC-11F8 in Participants With Colorectal Cancer

Summary: The purpose of this study is to determine if IMC-11F8 in combination with chemotherapy is effective in treating colorectal cancer (CRC).

Detailed description: The purpose of this study is to evaluate the anti-tumor activity (best overall response) of the anti-epidermal growth factor receptor (EGFR) monoclonal antibody IMC-11F8 administered in combination with mFOLFOX-6 chemotherapy regimen in treatment-naive, locally-advanced or metastatic CRC participants.

Eligibility: Inclusion Criteria:
  -  Histologically-confirmed, EGFR-detectable or EGFR-undetectable CRC
  -  Locally-advanced unresectable or metastatic adenocarcinoma of the colon or rectum
  -  At least 1 unidimensional-measurable target lesion by computed tomography (CT) scan or magnetic resonance imaging (MRI); target lesion(s) must not lie within an irradiated area
  -  Age ≥18 years
  -  Life expectancy of ≥6 months
  -  Eastern Cooperative Oncology Group (ECOG) performance status ≤2 at study entry
  -  Adequate hematologic function, as evidenced by an absolute neutrophil count (ANC) ≥1.5 x 10^9 liter (L), hemoglobin ≥10 grams per deciliter (g/dL), and platelets ≥100 x 10^9/L
  -  Adequate hepatic function as defined by a total bilirubin ≤1.5 milligrams per deciliter (mg/dL), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x upper limit of normal (ULN) (or 5.0 x ULN in the case of liver metastases), and alkaline phosphatase (AP) ≤2.5 x ULN (or 5.0 x ULN in the case of liver metastases)
  -  Adequate renal function as defined by a serum creatinine ≤1.5 x ULN, creatinine clearance ≥ 60 milliliters per minute (mL/min), or serum albumin ≥lower limit of normal (LLN)
  -  Participant's relevant toxicities/effects of prior therapy [surgery/radiation therapy (RT)] must have recovered to a stable or chronic level
  -  Participant agrees to use adequate contraception during the study period and for 4 weeks after the last dose of study treatment. Participants must notify the principal investigator if they themselves or their partner becomes pregnant.
  -  Participant has provided signed Informed Consent
  Exclusion Criteria:
  -  Has received prior systemic chemotherapy for locally-advanced unresectable or metastatic CRC.
  -  Has received prior radiotherapy to >25% of bone marrow
  -  Has documented and/or symptomatic brain metastases
  -  Has participated in clinical studies of non-approved experimental agents or procedures within 12 weeks of study entry
  -  Has received previous therapy with monoclonal antibodies
  -  Has received previous therapy with any agent that targets the EGFR
  -  Has serious concomitant medical conditions including active uncontrolled infection or cardiac disease, which in the opinion of the investigator, could compromise the participant or study.
  -  On chronic non-topical corticosteroid treatment for >6 months at doses >10 milligrams per day (mg/day) of prednisolone or equivalent before study entry, which in the opinion of the investigator could compromise the participant or the study
  -  Has a known dihydropyrimidine dehydrogenase deficiency
  -  Has a known allergy to any of the treatment components
  -  Has an acute or subacute intestinal occlusion
  -  Has peripheral neuropathy ≥Grade 2
  -  Has a history of other malignancies, with the exception of curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix
  -  If female, is pregnant (confirmed by urine or serum beta human chorionic gonadotropin test) or breast-feeding
  -  Has received a prior autologous or allogeneic organ or tissue transplantation
  -  Has interstitial pneumonia or interstitial fibrosis of the lung
  -  Has pleural effusion or ascites that causes ≥Grade 2 dyspnea
  -  Has psychological, familial, sociological, or geographical conditions which do not permit adequate study follow-up, compliance with the protocol, or signature of Informed Consent

Relevance to patient case: not relevant