Status:
COMPLETED
Phase II of Zactima Maintenance for Locally Advanced or Metastatic Non-small-cell Lung Carcinoma (NSCLC) Following Platinum-doublet Chemotherapy
Lead Sponsor:
Genzyme, a Sanofi Company
Conditions:
NSCLC
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study is multicenter, randomized, double-blinded, placebo-controlled Phase II study comparing vandetanib (300mg daily) plus best supportive care (BSC) to placebo plus BSC as maintenance treatment...
Eligibility Criteria
Inclusion
- Histologic or cytologic confirmation of locally advanced or metastatic NSCLC (IIIb-IV) at the time of original diagnosis.
- Completion of 4 cycles of chemotherapy of gemcitabine (1,000 or 1250mg/m\^2/day on day 1 and 8) and cisplatin (70-80mg/m\^2/day on day 1) every 3 weeks and have shown response, Complete Response(CR), Partial Response (PR) or stable disease (SD) by RECIST.
- WHO PS 0-1
- No prior radiotherapy to chest, immunotherapy or biologic therapy
Exclusion
- Mixed small cell and non small-cell lung cancer history.
- Prior treatment with EGFR TKIs or VEGFR TKIs (prior treatment with cetuximab \[Erbitux\] or bevacizumab \[Avastin\] is not permitted.)
- Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the study or which would jeopardize compliance with the protocol.
- Radiation therapy within 4 weeks before the start of study therapy. Major surgery within 4 weeks, or incomplete healed surgical incision before starting study therapy.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
117 Patients enrolled
Trial Details
Trial ID
NCT00777179
Start Date
October 1 2008
End Date
December 1 2011
Last Update
October 10 2016
Active Locations (5)
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1
Research Site
Cheongju-si, Republic of Korea, South Korea
2
Research Site
Gyeonggi-do, Republic of Korea, South Korea
3
Research Site
Gyeongsangnam-Do, Republic of Korea, South Korea
4
Research Site
Incheon, Republic of Korea, South Korea