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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 SiteAnaheim, California  
Research SiteArlington Heights, Illinois  
Research SiteBattle Kreek, Michigan  
Research SiteCharleston, South Carolina  
Research SiteChattanooga, Tennessee  
Research SiteAbilene, Texas