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An Open-Label, Dose-Finding Study to Evaluate the Safety of AMG 706 Plus Panitumumab Plus Gemcitabine-Cisplatin in the Treatment of Subjects With Advanced Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Lung Cancer, Pancreatic Cancer, Esophageal Cancer

Thank you

Trial Information

An Open-Label, Dose-Finding Study to Evaluate the Safety of AMG 706 Plus Panitumumab Plus Gemcitabine-Cisplatin in the Treatment of Subjects With Advanced Cancer


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)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

United States: Food and Drug Administration

Study ID:

20040206

NCT ID:

NCT00101907

Start Date:

January 2005

Completion Date:

April 2008

Related Keywords:

  • Lung Cancer
  • Pancreatic Cancer
  • Esophageal Cancer
  • Advanced Cancer
  • AMG 706
  • Panitumumab
  • Gemcitabine-Cisplatin
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Lung Neoplasms
  • Pancreatic Neoplasms
  • Neoplasms

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