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Study Complete
Sponsor ID
20101128

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

Sponsor ID
20101128
Clinicaltrials.gov ID
NCT01666977
EUCTIS ID
N/A
EudraCT ID
2011-001111-31
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Study Details

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

Additional Study Details

Phase
Phase 1/2
Product
AMG 386
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
36
Additional Study Details

Protocol Summary

Primary Outcome Measures

Progression Free Survival

Timeframe: Incidence of adverse events and clinical laboratory abnormalities defined as a DLT

Secondary Outcome Measures
Not Available

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

Location
Status
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Location
Research Site
Greenville, SC, United States, 29605
Status
Recruiting
Location
Research Site
Palm Springs, CA, United States, 92262
Status
Completed
Location
Research Site
Santa Monica, CA, United States, 90403
Status
Recruiting
Location
Research Site
Heidelberg, VIC, Australia, 3084
Status
Recruiting
Location
Research Site
Camperdown, NSW, Australia, 2050
Status
Recruiting
Location
Research Site
Paducah, KY, United States, 42003
Status
Completed
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Study Info
Age
18 - 95 Years
Condition
  • Lung Cancer - Non-Small Cell
    • Sex
    All
    Trial Dates
    Aug 2012 - Nov 2015
    Inclusion and Exclusion 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