A Phase 1b/2 Study of AMG 655 in Combination With Paclitaxel and Carboplatin for the First-Line Treatment of Advanced Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00534027
First received: September 20, 2007
Last updated: August 4, 2011
Last verified: August 2011
  Purpose

Part 1 is complete. Part 2 is a multi-center, randomized, double-blind, placebo-controlled, phase 2 segment that will commence upon identification of the maximum tolerated dose in part 1. The Primary objective of Part 2 of the study is to estimate efficacy in combination with carboplatin and paclitaxel. Subjects will be randomized at a 1:1:1 ratio to 1 of 3 treatment arms. Subjects in each of the 3 arms will receive up to 6 cycles of paclitaxel/carboplatin (at the same dose and schedule in part 1) in combination with either AMG 655 at the maximum tolerated dose (Arm 1), AMG 655 at a lower dose (Arm 2), or AMG 655 placebo (Arm 3) IV Q3W. Randomization will be stratified by ECOG (0 or 1) and disease stage (IIIb or IV/recurrent).


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: AMG 655
Other: AMG 655 placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1b/2 Study of AMG 655 in Combination With Paclitaxel and Carboplatin for the First-Line Treatment of Advanced Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: Until disease progression ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response rate, duration of response, time to response, overall survival and incidence of adverse events and clinical laboratory abnormalities [ Time Frame: Until disease progression ] [ Designated as safety issue: No ]

Enrollment: 172
Study Start Date: January 2008
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 2
Low Dose AMG 655 with paclitaxel/carboplatin
Drug: AMG 655
AMG 655 is a monoclonal antibody directed against TR-2.
Other Name: Placebo
Placebo Comparator: Arm 3
Placebo with paclitaxel/carboplatin
Other: AMG 655 placebo
Inactive dummy AMG 655 (to maintain blind)
Experimental: Arm 1
AMG 655 High doseplus paclitaxel/carboplatin
Drug: AMG 655
AMG 655 is a monoclonal antibody directed against TR-2.
Other Name: Placebo

  Eligibility

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

Inclusion Criteria:

  • Disease Related

    • Histologically or cytologically confirmed non-small cell lung cancer.
    • Subjects must have advanced non-small cell lung cancer defined as stage IIIB with malignant pleural effusion or stage IV or recurrent disease.
    • Planning to receive up to 6 cycles of chemotherapy
    • Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 Demographic
    • Men or women > 18 years of age Ethical
    • Adequate Hematological, renal, hepatic and coagulation function General
    • Plan to begin protocol specific therapy < 7 days after enrollment/randomization

Exclusion Criteria:

  • Disease Related

    • Untreated or symptomatic central nervous system metastases. Subjects with a history of brain metastases are eligible if definitive therapy has been administered (surgery and/or radiation therapy), there is no planned treatment for brain metastasis and the subject is clinically stable and off corticosteroids for at least 14 days before enrollment/randomization.
    • Prior chemotherapy as follows:
    • Any prior chemotherapy for advanced non-small cell lung cancer
    • Any prior adjuvant chemotherapy for non-small cell lung cancer < 52 weeks prior to enrollment/randomization. Adjuvant chemotherapy completed > 52 weeks prior to randomization is permitted.
    • Any prior chemoradiation.
    • Central (chest) radiation therapy < 28 days prior to randomization, radiation therapy for peripheral lesions < 14 days prior to enrollment/randomization
    • Other abnormal medical conditions
    • Documented myocardial infarction or unstable/uncontrolled cardiac condition
    • History of arterial thrombosis, pulmonary embolus, deep vein thrombosis or hemorrhagic disorders
    • Major surgical procedure < 30 days prior to enrollment/randomization or not yet recovered from prior major surgery, Minor surgical procedure < 7 days prior to enrollment/randomization or not yet recovered from prior minor surgery
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00534027

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided by Amgen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00534027     History of Changes
Other Study ID Numbers: 20060295
Study First Received: September 20, 2007
Last Updated: August 4, 2011
Health Authority: Australia: Therapeutic Goods Administration
Belgium: Federal Public Service (FPS) Health, Food Chain Safety and Environment
Canada: Health Canada
Spain: Agencia Española de Medicamentos y Productos Sanitarios
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Keywords provided by Amgen:
NSCLC
Non-Small Cell Lung Cancer
Paclitaxel
Carboplatin
AMG 655

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on July 28, 2014