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Randomized, Double-blinded, Placebo-controlled Phase II Study of Vandetanib (ZactimaTM) Maintenance for Locally Advanced or Metastatic Non-small-cell Lung Carcinoma (NSCLC) Following Platinum-doublet Chemotherapy


Phase 2
18 Years
N/A
Not Enrolling
Both
NSCLC

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Trial Information

Randomized, Double-blinded, Placebo-controlled Phase II Study of Vandetanib (ZactimaTM) Maintenance for Locally Advanced or Metastatic Non-small-cell Lung Carcinoma (NSCLC) Following Platinum-doublet Chemotherapy


Inclusion Criteria:



- 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 Criteria:

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Progression-free Survival (PFS) Rate at 3 Months

Outcome Description:

Progression-free survival (PFS) rate at 3 months is defined as the number of patients without evidence of progression or death after 3 months from randomisation among the PFS-evaluable patients.

Outcome Time Frame:

12 weeks

Safety Issue:

No

Principal Investigator

MyungJu Ahn

Investigator Role:

Principal Investigator

Investigator Affiliation:

Samsung Medical Center

Authority:

South Korea: Korea Food and Drug Administration (KFDA)

Study ID:

D4200C00077

NCT ID:

NCT00777179

Start Date:

October 2008

Completion Date:

December 2011

Related Keywords:

  • NSCLC
  • Vandetanib, NSCLC, Maintenance, Phase II
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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