Status:
TERMINATED
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.
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This single arm study in patients with advanced Stage IIIb/IV NSCLC who have progressive disease after deriving clinical benefit (defined as response or stable disease after 12 weeks) from second or t...
Eligibility Criteria
Inclusion
- male or female patients \>=18 years with histologically documented inoperable, locally advanced or metastatic (stage IIIB or IV) NSCLC;
- 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
- patients with active CNS lesions;
- 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.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00773383
Start Date
November 1 2008
End Date
February 1 2010
Last Update
June 24 2013
Active Locations (16)
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1
Santa Monica, California, United States, 90404
2
Miami, Florida, United States, 33101
3
Boston, Massachusetts, United States, 02114
4
Boston, Massachusetts, United States, 02115