Study to Evaluate AMG 706 With or Without Carboplatin/Paclitaxel or Panitumumab in the Treatment of Subjects With Advanced Non-Small Cell Lung Cancer (NSCLC) - Full Text View

Sponsored by:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00094835

Purpose

The purpose of this trial is: - 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). - To establish the pharmacokinetic (PK) profile of AMG 706 when it is used in combination with CP, with panitumumab, or with CP and panitumumab. - To compare the paclitaxel and AMG 706 PK profiles when the medications are administered 30 minutes (min) or approximately 48 hours (hrs) apart. - To characterize the panitumumab and paclitaxel exposure in the combination regimens of AMG 706 with CP, AMG 706 with panitumumab, or AMG 706 with CP and panitumumab. - To describe the objective response rate (ORR) in each dose cohort. - To measure the immunogenicity of panitumumab in subjects administered AMG 706 with panitumumab and AMG 706 with CP and panitumumab.

Condition	Intervention	Phase
Lung Cancer Non-Small Cell Lung Cancer	Biological: Panitumumab Drug: AMG 706	Phase I Phase II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Carboplatin Paclitaxel Immunoglobulins Globulin, Immune Motesanib Panitumumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study
Official Title:	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)

Further study details as provided by Amgen:

Primary Outcome Measures:

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). [ Time Frame: Incidence of adverse events and clinical laboratory abnormalities defined as dose limiting toxicities ] [ Designated as safety issue: Yes ]
To establish the pharmacokinetic (PK) profile of AMG 706 when it is used in combination with CP, with panitumumab, or with CP and panitumumab. [ Time Frame: Incidence of adverse events and clinical laboratory abnormalities defined as dose limiting toxicities ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To compare the paclitaxel and AMG 706 PK profiles when the medications are administered 30 minutes (min) or approximately 48 hours (hrs) apart. [ Time Frame: Incidence of adverse events and clinical laboratory abnormalities defined as dose limiting toxicities ] [ Designated as safety issue: Yes ]
To characterize the panitumumab and paclitaxel exposure in the combination regimens of AMG 706 with CP, AMG 706 with panitumumab, or AMG 706 with CP and panitumumab. [ Time Frame: Incidence of adverse events and clinical laboratory abnormalities defined as dose limiting toxicities ] [ Designated as safety issue: Yes ]
To describe the objective response rate (ORR) in each dose cohort. [ Time Frame: Nine weeks of treatment ] [ Designated as safety issue: No ]
To measure the immunogenicity of panitumumab in subjects administered AMG 706 with panitumumab and AMG 706 with CP and panitumumab. [ Time Frame: Incidence of anti-panitumumab antibody formation ] [ Designated as safety issue: Yes ]

Enrollment:	51
Study Start Date:	January 2005
Study Completion Date:	March 2007
Primary Completion Date:	March 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Segment B: Experimental Panitumumab plus AMG 706	Biological: Panitumumab High affinity fully human IgG2 monoclonal antibody directed against human EGFr. Drug: AMG 706 Small organic molecule
Segment A: Experimental Paclitaxel and carboplatin plus AMG 706.	Drug: AMG 706 Small organic molecule
Segment C: Experimental Panitumumab and AMG 706 plus carboplatin and paclitaxel	Biological: Panitumumab High affinity fully human IgG2 monoclonal antibody directed against human EGFr. Drug: AMG 706 Small organic molecule

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00094835

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

Center Watch Clinical Trials Listing Service This link exits the ClinicalTrials.gov site

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20040153
Study First Received:	October 27, 2004
Last Updated:	June 19, 2008
ClinicalTrials.gov Identifier:	NCT00094835
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

Keywords provided by Amgen:

Lung cancer, Non-small cell lung cancer, NSCLC
Immunex, Abgenix, Amgen
Stage IIIB, Stage IV, Unresectable
Clinical Trial, Panitumumab, AMG 706
Anti-angiogenesis

Study placed in the following topic categories:

Thoracic Neoplasms
Non-small cell lung cancer
Carboplatin
Carcinoma
Antibodies, Monoclonal
Signs and Symptoms
Antibodies

Respiratory Tract Diseases
Lung Neoplasms
Paclitaxel
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Immunoglobulins
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Mitosis Modulators
Tubulin Modulators
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009