Clinical trial NCT00630786 (phase 1/phase 2, status: completed)
Conditions: colon cancer, colorectal cancer, rectal cancer, metastatic colorectal cancer, oncology
ICD codes: C18.2, C18.4, C18.6, C18.7, C18.9, D12.2, D12.3, C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2, C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2, C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: panitumumab, conatumumab
SMILES: NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)C1(F)F
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed metastatic adenocarcinoma of the colon or
             rectum

          -  Radiographically documented disease progression per modified Response Evaluation
             Criteria in Solid Tumors (RECIST) during or following treatment with fluoropyrimidine,
             irinotecan, and/or oxaliplatin chemotherapy for Metastatic Colorectal Cancer.
             Progressive disease must be documented during or ≤ 6 months after the last dose of the
             most recent chemotherapy regimen prior to enrollment.

          -  At least 1 uni-dimensionally measurable lesion measuring ≥ 20 mm in one dimension per
             modified RECIST. Lesion must not be chosen from a previously irradiated field, unless
             there has been documented disease progression in that field after irradiation and
             prior to enrollment. All sites of disease must be evaluated.

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          -  Available archived paraffin-embedded tumor tissue from the primary tumor or metastasis
             for submission to the central laboratory

          -  Man or woman ≥ 18 years of age at the time of enrollment

          -  Hematologic function within the following limits:

               -  Absolute neutrophil count (ANC) > 1.0 x 10^9 cells/L

               -  Platelets ≥ 100 x 10^9/L

          -  Renal function within the following limits:

               -  Creatinine < 2.0 mg/dL

          -  Hepatic function within the following limits:

               -  Aspartate aminotransferase (AST) ≤ 2.5 x upper limit of normal (ULN) (≤ 5 x ULN
                  if liver metastases)

               -  Alanine aminotransferase (ALT) ≤ 2.5 x ULN (≤ 5 x ULN if liver metastases)

               -  Bilirubin ≤ 2 x ULN

          -  Metabolic function within the following limits:

               -  Amylase ≤ 2 x ULN

               -  Lipase ≤ 2 x ULN

               -  Magnesium ≥ lower limit of normal

          -  Negative pregnancy test ≤ 72 hours before enrollment (for woman of childbearing
             potential only)

          -  Must have received 1, 2, or 3 prior chemotherapy regimens for Metastatic Colorectal
             Cancer

          -  Competent to comprehend, sign, and date the independent ethics committee/institutional
             review board (IEC/IRB) approved written informed consent

        Exclusion Criteria:

          -  History of other primary cancer, unless:

               -  Curatively resected non-melanomatous skin cancer

               -  Curatively treated cervical carcinoma in situ

               -  Other primary solid tumor curatively treated with no known active disease present
                  and no treatment administered for ≥ 5 years before enrollment

          -  Prior treatment with anti-epidermal growth factor receptor (EGFr) inhibitors (eg,
             cetuximab, erlotinib, gefitinib), unless treatment was received in the adjuvant
             setting ≥ 6 months before enrollment

          -  Use of systemic chemotherapy and radiotherapy ≤ 30 days before enrollment

          -  Use of prior anti-tumor therapies with a short serum half-life (less than 1 week)
             including prior experimental agents or approved anti-tumor small molecules ≤ 30 days
             before enrollment

          -  Use of anti-tumor therapies with a longer serum half-life (eg, bevacizumab) including
             prior experimental or approved protein/antibodies ≤ 42 days before enrollment

          -  Any investigational agent or therapy ≤ 30 days before enrollment

          -  Known allergy or hypersensitivity to any component of panitumumab and/or AMG 655

          -  History of or known presence of central nervous system (CNS) metastases

          -  History of interstitial lung disease (eg, pneumonitis, pulmonary fibrosis) or evidence
             of interstitial lung disease on baseline chest computerized tomography (CT) scan

          -  Clinically significant cardiovascular disease (including myocardial infarction,
             unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac
             arrhythmia) ≤ 1 year before enrollment

          -  Active inflammatory bowel disease or other active bowel disease causing chronic
             diarrhea (defined as ≥ Common Terminology Criteria for Adverse Events [CTCAE] grade 2
             [CTCAE version 3.0])

          -  Known positive test for human immunodeficiency virus (HIV) infection, hepatitis C
             virus, acute or chronic hepatitis B infection

          -  Any co-morbid disease or condition that could increase the risk of toxicity (eg,
             significant ascites, significant pleural effusion)

          -  Any uncontrolled concurrent illness (eg, infection, bleeding) or history of any
             medical condition that may interfere with the interpretation of the study results

          -  Major surgical procedure (requiring general anesthesia) ≤ 28 days or minor surgical
             procedure (excluding central venous catheter placement) ≤ 14 days before enrollment.
             Patients must have recovered from surgery related toxicities.

          -  Other investigational procedures are excluded

          -  Patient is currently pregnant or breast feeding

          -  Man or woman of childbearing potential who is not willing to use adequate
             contraceptive precautions during treatment and for 6 months (for women) or 1 month
             (for men) after the last investigational product administration. Adequate
             contraceptive precautions includes double barrier contraceptive methods (eg, diaphragm
             and condom) or abstinence.

          -  Previously enrolled into this study

          -  Patient unwilling or unable to comply with study requirements