Phase 1b/2 Trial of AMG386 With Pemetrexed and Carboplatin in Non-Small Cell Lung Cancer
NCT ID: NCT01666977
Last Updated: 2016-06-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
36 participants
INTERVENTIONAL
2012-08-31
2015-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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
AMG 386 Placebo
AMG 386 Placebo
Pemetrexed
Pemetrexed 500 mg/m2
Carboplatin
Carboplatin AUC 6
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
AMG 386
15mg/kg
Pemetrexed
Pemetrexed 500 mg/m2
Carboplatin
Carboplatin AUC 6
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
AMG 386
30 mg/kg
Pemetrexed
Pemetrexed 500 mg/m2
Carboplatin
Carboplatin AUC 6
Interventions
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AMG 386
15mg/kg
AMG 386
30 mg/kg
AMG 386 Placebo
AMG 386 Placebo
Pemetrexed
Pemetrexed 500 mg/m2
Carboplatin
Carboplatin AUC 6
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
95 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Fayetteville, Arkansas, United States
Research Site
Hot Springs, Arkansas, United States
Research Site
Los Angeles, California, United States
Research Site
Palm Springs, California, United States
Research Site
Pleasant Hill, California, United States
Research Site
San Diego, California, United States
Research Site
Santa Monica, California, United States
Research Site
Peoria, Illinois, United States
Research Site
Paducah, Kentucky, United States
Research Site
Hannover, New Hampshire, United States
Research Site
The Bronx, New York, United States
Research Site
Bismarck, North Dakota, United States
Research Site
Greenville, South Carolina, United States
Research Site
Camperdown, New South Wales, Australia
Research Site
Kogarah, New South Wales, Australia
Research Site
Randwick, New South Wales, Australia
Research Site
Tweed Heads, New South Wales, Australia
Research Site
Herston, Queensland, Australia
Research Site
Bentleigh East, Victoria, Australia
Research Site
Heidelberg, Victoria, Australia
Research Site
Brussels, , Belgium
Research Site
Hamilton, Ontario, Canada
Research Site
Oshawa, Ontario, Canada
Research Site
Ottawa, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Laval, Quebec, Canada
Research Site
Lévis, Quebec, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Heraklion, , Greece
Research Site
Larissa, , Greece
Research Site
Pátrai, , Greece
Research Site
Thessaloniki, , Greece
Research Site
Málaga, Andalusia, Spain
Research Site
Zaragoza, Aragon, Spain
Research Site
Madrid, Madrid, Spain
Countries
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2011-001111-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20101128
Identifier Type: -
Identifier Source: org_study_id
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