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An Open-label, Dose-finding Study to Evaluate the Safety and Pharmacokinetics (PK) of AMG 706 With Carboplatin/Paclitaxel, AMG 706 With Panitumumab and AMG 706 With Panitumumab and Carboplatin/Paclitaxel in the Treatment of Subjects With Advanced Non-Small Cell Lung Cancer (NSCLC)


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer, Non-small Cell Lung Cancer

Thank you

Trial Information

An Open-label, Dose-finding Study to Evaluate the Safety and Pharmacokinetics (PK) of AMG 706 With Carboplatin/Paclitaxel, AMG 706 With Panitumumab and AMG 706 With Panitumumab and Carboplatin/Paclitaxel in the Treatment of Subjects With Advanced Non-Small Cell Lung Cancer (NSCLC)


Inclusion Criteria:



- Diagnosis of unresectable stage IIIB or IV non-small cell lung cancer (NSCLC)

- No more than one prior chemotherapy

- Adequate hematologic, renal and hepatic function

- Measurable disease or evaluable disease on CAT scan or MRI

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

- Able to fast for 10 hrs twice during the study - Able to tolerate oral medications

- Life expectancy of at least 3 months

Exclusion Criteria:

- Symptomatic or untreated central nervous system metastases requiring current
treatment

- History of arterial thrombosis within 1 year prior to enrollment

- Anticoagulant therapy, except for warfarin of less than 2mg per day

- Symptomatic peripheral neuropathy

- History of pulmonary hemorrhage or hemoptysis

- Myocardial infarction within 1 year before enrollment

- Uncontrolled hypertension [diastolic greater than 85 mmHg; systolic greater than 145
mmHg]

- History of other cancer, unless treated with no known active disease for longer than
3 years

- Previous treatment with AMG 706 or panitumumab, previous treatment with inhibitors of
VEGF or EGF

- No antibody treatment for 6 weeks prior to enrollment

- Known HIV positive, hepatitis C positive or hepatitis B surface antigen positive

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To characterize the safety profile of AMG 706 when used in combination with carboplatin/paclitaxel (CP), with panitumumab or with CP and panitumumab in subjects with advanced non-small cell lung cancer (NSCLC).

Outcome Time Frame:

Incidence of adverse events and clinical laboratory abnormalities defined as dose limiting toxicities

Safety Issue:

Yes

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

United States: Food and Drug Administration

Study ID:

20040153

NCT ID:

NCT00094835

Start Date:

January 2005

Completion Date:

March 2007

Related Keywords:

  • Lung Cancer
  • Non-Small Cell Lung Cancer
  • Lung cancer, Non-small cell lung cancer, NSCLC
  • Immunex, Abgenix, Amgen
  • Stage IIIB, Stage IV, Unresectable
  • Clinical Trial, Panitumumab, AMG 706
  • Anti-angiogenesis
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Research Site Anaheim, California  
Research Site Arlington Heights, Illinois  
Research Site Battle Kreek, Michigan  
Research Site Charleston, South Carolina  
Research Site Chattanooga, Tennessee  
Research Site Abilene, Texas