A Study of the Effect of R1507 in Combination With Tarceva (Erlotinib) on Progression-Free Survival in Patients With Stage IIIb/IV Non-Small Cell Lung Cancer (NSCLC) Having Received Tarceva Monotherapy.
NCT ID: NCT00773383
Last Updated: 2013-06-24
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
35 participants
INTERVENTIONAL
2008-11-30
2010-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
RG1507
iv 9mg/kg weekly
erlotinib [Tarceva]
150mg oral daily
Interventions
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RG1507
iv 9mg/kg weekly
erlotinib [Tarceva]
150mg oral daily
Eligibility Criteria
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Inclusion Criteria
* currently receiving Tarceva monotherapy and having failed at least one standard chemotherapy regimens;
* prior response or stable disease 12 weeks from start of Tarceva;
* documented progressive disease at enrollment;
* measurable disease according to the RECIST criteria;
* ECOG performance status 0-2;
* life expectancy \>12 weeks.
Exclusion Criteria
* prior treatment with agents acting via IGF-1R inhibition or EGFR targeting;
* administration with high doses of systemic corticosteroids;
* radiotherapy in the 4 weeks prior to study start;
* surgery or significant traumatic injury with in the last 2 weeks prior to study start.
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Santa Monica, California, United States
Miami, Florida, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Hickory, North Carolina, United States
Calgary, Alberta, Canada
Ottawa, Ontario, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Marseille, , France
Paris, , France
Villejuif, , France
Gdansk, , Poland
Lublin, , Poland
Poznan, , Poland
Countries
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Other Identifiers
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2008-001762-85
Identifier Type: -
Identifier Source: secondary_id
NO21746
Identifier Type: -
Identifier Source: org_study_id
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