Safety of AMG 706 Plus Panitumumab Plus Chemotherapy in the Treatment of Subjects With Metastatic Colorectal Cancer

• Status: Completed
• Trial end date: 2011-12-01
• 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 either FOLFIRI or FOLFOX4 chemotherapy regimens. This is a Phase 1b clinical study.

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

Details

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

Criteria

For complete inclusion and exclusion criteria, please refer to the investigator. Inclusion Criteria

1. Competent to comprehend, sign, and date an Institutional Review Board (IRB) approved informed consent form

2. Diagnosis of metastatic colorectal adenocarcinoma (may have received 1 prior chemotherapy regimen for metastatic CRC)

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

4. Adequate hematological function

5. Adequate renal function

6. Adequate hepatic function

7. Life expectancy of greater than or equal to 3 months as documented by the investigator

Exclusion Criteria:

1. More than 1 prior chemotherapy regimen for metastatic CRC

2. Central nervous system (CNS) metastases

3. History of venous thrombosis

4. Myocardial infarction, cerebrovascular accident, transient ischemic attack, grade 2 or greater peripheral vascular disease, congestive heart failure, ongoing arrhythmias requiring medication, or unstable angina within 1 year before study enrollment

5. History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on screening chest computed tomograph (CT) scan

6. Average systolic blood pressure > 150mm Hg or average diastolic blood pressure of > 90mm Hg

7. Radiotherapy within 28 days of study enrollment or within 14 days of study enrollment for peripheral lesions

8. Prior AMG 706, oral inhibitors of AMG706, panitumumab, or another anti-EGFr monoclonal antibody (mAb) (e.g., cetuximab [Erbitux®] or EMD 72000)

9. Systemic chemotherapy within 28 days before study enrollment

10. Major surgery within 28 days or minor surgery within 7days of study enrollment

11. History of life threatening ventricular arrhythmia (eg, sustained ventricular tachycardia)

12. Female and male subjects of childbearing potential not using adequate contraceptive precautions

13. Participation in therapeutic clinical trials within 30 days before study enrollment

14. Not recovered from all previous therapies

15. Clinically significant open would, ulcer or fracture

16. Any co-morbid medical condition that would increase the risk of toxicity