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Study Complete
Sponsor ID
20060295

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

Sponsor ID
20060295
Clinicaltrials.gov ID
NCT00534027
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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).

Additional Study Details

Phase
Phase 1/Phase 2
Product
conatumumab
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
172
Additional Study Details

Protocol Summary

Primary Outcome Measures

Progression free survival

Timeframe: Until disease progression

Secondary Outcome Measures

Objective response rate, duration of response, time to response, overall survival and incidence of adverse events and clinical laboratory abnormalities

Timeframe: Until disease progression

Study Documents

Study Synopsis
Available Language(s): English
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Locations

No locations found.
Study Info
Age
18+ years
Condition
  • Lung Cancer - Non-Small Cell
    • Sex
    All
    Trial Dates
    Jan 2008 - Mar 2011
    Inclusion and Exclusion 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