Open Label Extension Study of Conatumumab and Ganitumab (AMG 479)
Condition: Advanced Solid Tumors; Carcinoid; Colorectal Cancer; Locally Advanced; Lymphoma; Metastatic Cancer; Non-Small Cell Lung Cancer; Sarcoma; Solid Tumors
MeSH terms: Neoplasms; Neoplasm Metastasis; Carcinoid Tumor
Intervention: Modified FOLFOX6; Conatumumab; Ganitumab; Bevacizumab
Intervention description: The mFOLFOX6 regimen is a combination therapy of oxaliplatin 85 mg/m² administered as a 2-hour intravenous (IV) infusion on day 1 and leucovorin 400 mg/m² racemate or 200 mg/m² levo-leucovorin administered as a 2-hour infusion on day 1, followed by a loading dose of 5-fluorouracil (5-FU) 400 mg/m² IV bolus administered on day 1, then 5-FU 2400 mg/m² via ambulatory pump administered for a period of 46 to 48 hours every 14 days.; Administered by intravenous infusion Q2W or Q3W.; Administered by intravenous infusion Q3W or Q4W.; Administered at a dose of 5 mg/kg by intravenous infusion on day 1 of each 14 day cycle.
Intervention MeSH terms: Leucovorin; Bevacizumab; Conatumumab; Fluorouracil; Oxaliplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: AMG 655; AMG 479; Apoptosis; Monoclonal Antibody; Tumor Necrosis Factor; Insulin-like Growth Factor; Bevacizumab; Modified FOLFOX6; mFOLFOX6; FOLFOX; Lymphoma; Trail Receptor; ganitumab; conatumumab

Summary:

      The purpose of this protocol is to allow continued treatment with conatumumab and/or
      ganitumab, with or without chemotherapy, to participants who completed a separate
      Amgen-sponsored conatumumab or ganitumab study without disease progression whose previous
      studies were closed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  To be enrolled in this study, subjects must be currently enrolled in a prior
             Amgen-sponsored conatumumab or AMG 479 study and are eligible according to the parent
             study to receive their next dose of conatumumab (with or without co-therapy), or AMG
             479 alone.

        Subjects must have their eligibility assessed for this study and be enrolled within 30 days
        of their last treatment on the parent protocol

        Exclusion Criteria:

          -  Discontinued from a conatumumab study due to an adverse event considered by the
             investigator to be related to conatumumab treatment, including intolerance to
             conatumumab

          -  Subjects determined to have disease progression during their participation in the
             parent Amgen study

          -  Woman or man with partner of childbearing potential not consenting to use adequate
             contraceptive precautions ie, double barrier contraceptive methods (eg, diaphragm plus
             condom), or abstinence during the course of the study and for 6 months after the last
             dose of protocol-specified therapy administration

          -  Subject is pregnant or breast feeding, or planning to become pregnant within 6 months
             after the last dose of protocol-specified therapy administration

          -  Male subject with a pregnant partner who is not willing to use a condom during
             treatment and for an additional 6 months after the last dose of protocol-specified
             therapy administration

          -  Subject has previously entered this study

          -  Subject will not be available for protocol required study visits, to the best of the
             subject and investigator's knowledge

          -  Subject has any kind of disorder that, in the opinion of the investigator, may
             compromise the ability of the subject to give written informed consent and/or to
             comply with all required study procedures