Safety of AMG 706 Plus Panitumumab Plus Gemcitabine-Cisplatin in the Treatment of Patients With Advanced Cancer
Condition: Lung Cancer; Pancreatic Cancer; Esophageal Cancer
Intervention: AMG 706; Panitumumab; Gemcitabine; Cisplatin
Intervention description: AMG 706 will be provided as 25-mg and 100-mg tablets and will be continuously self-administered orally once or twice daily based on cohort assignment starting on day 1 of Cycle 1.; Panitumumab will be administered by intravenous (IV) infusion at a dose of 9 mg/kg on Day 1 of each 3-week cycle.; Gemcitabine will be administered intravenously on Day 1 and Day 8 of each 21-day cycle at a dose of 1250 mg/m^2.; Cisplatin will be administered intravenously on Day 1 of each 3-week cycle at a dose of 75 mg/m^2.
Intervention MeSH terms: Gemcitabine; Panitumumab; Motesanib diphosphate
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Advanced Cancer; AMG 706; Panitumumab; Gemcitabine-Cisplatin

Summary:

      The purpose of this study is to characterize the safety and tolerability of AMG 706 plus
      panitumumab when administered with gemcitabine and cisplatin chemotherapy. This is a Phase 1b
      clinical study.
    

Eligibility criteria:

        For complete inclusion and exclusion, please refer to the investigator.

        Inclusion Criteria:

          -  Competent to comprehend, sign, and date an Institutional Review Board (IRB) approved
             informed consent form

          -  Subjects with advanced cancer in whom the gemcitabine and cisplatin chemotherapy
             regimen is clinically indicated

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          -  Adequate hematological function

          -  Adequate renal function

          -  Adequate hepatic function

          -  Life expectancy of greater than or equal to 3 months as documented by the investigator

        Exclusion Criteria:

          -  More than 1 prior chemotherapy regimen

          -  History of venous thrombosis

          -  Myocardial infarction, cerebrovascular accident, transient ischemic attack,
             percutaneous transluminal coronary angioplasty/stent, or unstable angina within 1 year
             before study enrollment

          -  History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial
             pneumonitis or pulmonary fibrosis on screening chest computed tomograph (CT) scan

          -  Average systolic blood pressure of greater than 145 mm Hg or average diastolic blood
             pressure of greater than 85 mm Hg

          -  Radiotherapy within 28 days of study enrollment or within 14 days of study enrollment
             for peripheral lesions

          -  Prior AMG 706, panitumumab, or another anti-EGFr monoclonal antibody (mAb) (e.g.,
             cetuximab [Erbitux®] or EMD 72000)

          -  Systemic chemotherapy within 28 days before study enrollment

          -  Major surgery within 28 days or minor surgery within 14 days of study enrollment

          -  Central nervous system metastases (Exception: subjects with treated asymptomatic
             central nervous system metastases, those who have been clinically stable in the
             judgment of the investigator and off steroids for at least 30 days before the study
             enrollment are eligible)