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Phase 1b/2 Trial of AMG386 With Pemetrexed and Carboplatin in Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT01666977
Recruitment Status : Completed
First Posted : August 17, 2012
Last Update Posted : June 3, 2016
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Description
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Brief Summary:
The purpose of this phase 1b/2 study is to estimate the treatment effect of study drug measuring progression free survival.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Drug: AMG 386 Drug: AMG 386 Placebo Drug: Pemetrexed Drug: Carboplatin Phase 1 Phase 2

Detailed Description:
To evaluate the incidence of adverse events and clinical laboratory abnormalities defined as dose-limiting toxicity in subjects with metastatic non-squamous non-small cell lung cancer (NSCLC) treated with AMG 386 in combination with pemetrexed and carboplatin
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1b/2 Trial of AMG 386 in Combination With Pemetrexed and Carboplatin as First Line Treatment of Metastatic Non-Squamous Non-Small Cell Lung Cancer
Study Start Date : August 2012
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm A
Arm A: AMG 386 placebo IV QW, pemetrexed 500 mg/m2 IV Q3W, carboplatin AUC 6 IV Q3W, for up to 6 cycles
 Drug: AMG 386 Placebo
AMG 386 Placebo

Drug: Pemetrexed
Pemetrexed 500 mg/m2

Drug: Carboplatin
Carboplatin AUC 6
Experimental: Arm B
Arm B: AMG 386 15 mg/kg IV QW, pemetrexed 500 mg/m2 IV Q3W, carboplatin AUC 6 IV Q3W, for up to 6 cycles
 Drug: AMG 386
15mg/kg

Drug: Pemetrexed
Pemetrexed 500 mg/m2

Drug: Carboplatin
Carboplatin AUC 6
Experimental: Arm C
Arm C: AMG 386 30 mg/kg IV QW, pemetrexed 500 mg/m2 IV Q3W, carboplatin AUC 6 IV Q3W, for up to 6 cycles
 Drug: AMG 386
30 mg/kg

Drug: Pemetrexed
Pemetrexed 500 mg/m2

Drug: Carboplatin
Carboplatin AUC 6


Outcome Measures
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Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: Incidence of adverse events and clinical laboratory abnormalities defined as a DLT ]
    Subjects will be evaluated for progression free survival.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed, unresectable stage IV non-squamous non small cell lung cancer (NSCLC)
  • Radiographically evaluable disease (measurable or non-measurable) per RECIST 1.1 with modifications
  • Adequate hematological, renal, and hepatic function, normal coagulation profile, calculated CrCL ≥ 45 mL/min
  • Other criteria may apply

Exclusion Criteria:

  • Any prior chemotherapy or targeted therapy for non-squamous NSCLC
  • Subjects with adenosquamous histology or any histology subtype containing greater than 10% squamous cells
  • Subjects with an epidermal growth factor receptor (EGFR) mutation sensitive to treatment with a tyrosine kinase inhibitor (TKI)
  • Subjects with known anaplastic lymphoma kinase (EML4-ALK) translocations
  • History or presence of central nervous system metastases
  • Central (chest) radiation therapy within 28 days prior to enrollment/randomization, radiation therapy to any other site(s) within 14 days prior to enrollment/randomization
  • History of pulmonary hemorrhage or gross hemoptysis within 6 months
  • History of arterial or venous thromboembolism within 12 months
  • History of clinically significant bleeding within 6 months
  • Clinically significant cardiovascular disease within 12 months
  • Other criteria may apply
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01666977


Locations
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United States, Arkansas
Research Site
Fayetteville, Arkansas, United States, 72703
Research Site
Hot Springs, Arkansas, United States, 71913
United States, California
Research Site
Los Angeles, California, United States, 90048
Research Site
Palm Springs, California, United States, 92262
Research Site
Pleasant Hill, California, United States, 94523
Research Site
San Diego, California, United States, 92123
Research Site
Santa Monica, California, United States, 90403
United States, Illinois
Research Site
Peoria, Illinois, United States, 61615
United States, Kentucky
Research Site
Paducah, Kentucky, United States, 42003
United States, New Hampshire
Research Site
Hannover, New Hampshire, United States, 03756
United States, New York
Research Site
Bronx, New York, United States, 10461
United States, North Dakota
Research Site
Bismarck, North Dakota, United States, 58501
United States, South Carolina
Research Site
Greenville, South Carolina, United States, 29605
Australia, New South Wales
Research Site
Camperdown, New South Wales, Australia, 2050
Research Site
Kogarah, New South Wales, Australia, 2217
Research Site
Randwick, New South Wales, Australia, 2031
Research Site
Tweed Heads, New South Wales, Australia, 2485
Australia, Queensland
Research Site
Herston, Queensland, Australia, 4029
Australia, Victoria
Research Site
Bentleigh East, Victoria, Australia, 3165
Research Site
Heidelberg, Victoria, Australia, 3084
Belgium
Research Site
Bruxelles, Belgium, 1200
Canada, Ontario
Research Site
Hamilton, Ontario, Canada, L8V 5C2
Research Site
Oshawa, Ontario, Canada, L1G 2B9
Research Site
Ottawa, Ontario, Canada, K1H 8L6
Research Site
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Research Site
Laval, Quebec, Canada, H7M 3L9
Research Site
Levis, Quebec, Canada, G6V 3Z1
Research Site
Montreal, Quebec, Canada, H2L 4M1
Greece
Research Site
Heraklion, Greece, 71110
Research Site
Larissa, Greece, 41110
Research Site
Patra, Greece, 26500
Research Site
Thessaloniki, Greece, 56429
Spain
Research Site
Málaga, Andalucía, Spain, 29010
Research Site
Zaragoza, Aragón, Spain, 50009
Research Site
Madrid, Spain, 28046
Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
More Information
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Additional Information:

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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01666977    
Other Study ID Numbers: 20101128
2011-001111-31 ( EudraCT Number )
First Posted: August 17, 2012    Key Record Dates
Last Update Posted: June 3, 2016
Last Verified: May 2016
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Carboplatin
Pemetrexed
 Trebananib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors