A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Phase III Study of Tariquidar + Vinorelbine as First-Line Therapy in Non-Small Cell Lung Cancer (NSCLC)
NCT00042315 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 490
Last updated 2012-05-23
Summary
To determine whether tariquidar + first-line single agent vinorelbine chemotherapy in patients with Stage IIIb/IV NSCLC will, with an acceptable safety profile, significantly improve overall survival compared with placebo + vinorelbine. To compare the effects of tariquidar/vinorelbine with placebo/vinorelbine on tumor response, time to disease progression, performance status, symptom progression, and quality of life in patients with Stage IIIb/IV NSCLC.
Conditions
- Stage IIIb Non-small Cell Lung Cancer
- Stage IV Non-small Cell Lung Cancer
Interventions
- PROCEDURE
-
Chemotherapy
- DRUG
-
tariquidar + vinorelbine
- DRUG
-
placebo + vinorelbine
Sponsors & Collaborators
-
QLT Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2002-06-30
- Primary Completion
- 2003-06-30
- Completion
- 2003-06-30
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