Safety of AMG 706 Plus Panitumumab Plus Gemcitabine-Cisplatin in the Treatment of Patients With Advanced Cancer

• Status: Terminated
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Antibodies, Monoclonal; Cisplatin; Gemcitabine; Motesanib diphosphate; Niacinamide; Panitumumab

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)