Know Cancer

or
forgot password

An Open-Label, Dose-Finding Study to Evaluate the Safety of AMG 706 Plus Panitumumab Plus Chemotherapy in the Treatment of Subjects With Metastatic Colorectal Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Rectal Cancer, Colon Cancer

Thank you

Trial Information

An Open-Label, Dose-Finding Study to Evaluate the Safety of AMG 706 Plus Panitumumab Plus Chemotherapy in the Treatment of Subjects With Metastatic Colorectal Cancer

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Part 1a - The incidence of adverse events and clinical laboratory abnormalities defined as dose-limiting toxicities

Outcome Time Frame:

First 2 cycles

Safety Issue:

Yes

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

United States: Food and Drug Administration

Study ID:

20040205

NCT ID:

NCT00101894

Start Date:

December 2004

Completion Date:

December 2011

Related Keywords:

  • Rectal Cancer
  • Colon Cancer
  • AMG 706
  • Panitumumab
  • Colonic Neoplasms
  • Rectal Neoplasms
  • Colorectal Neoplasms

Name

Location