A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Phase III Study of Tariquidar + Vinorelbine as First-Line Therapy in Non-Small Cell Lung Cancer (NSCLC)
- Sponsor
- QLT Inc.
- Study ID
- NCT00042315
- Phase
- PHASE3
- Status
- Terminated
Conditions
- Stage IIIb Non-small Cell Lung Cancer
- Stage IV Non-small Cell Lung Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Chemotherapy — PROCEDURE
- tariquidar + vinorelbine — DRUG
- placebo + vinorelbine — DRUG
Study Details
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.
Key Dates
- Start date
- Jun 30, 2002
- Status verified
- May 2012
- Primary completion
- Jun 30, 2003
- Completion
- Jun 30, 2003
Study Design
- Enrollment
- 490 participants
- Allocation
- RANDOMIZED
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