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Phase II of Zactima Maintenance for Locally Advanced or Metastatic Non-small-cell Lung Carcinoma (NSCLC) Following Platinum-doublet Chemotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00777179
Recruitment Status : Completed
First Posted : October 22, 2008
Results First Posted : July 8, 2011
Last Update Posted : October 10, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Tracking Information
First Submitted Date  ICMJE October 21, 2008
First Posted Date  ICMJE October 22, 2008
Results First Submitted Date  ICMJE April 27, 2011
Results First Posted Date  ICMJE July 8, 2011
Last Update Posted Date October 10, 2016
Study Start Date  ICMJE October 2008
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2012)
Progression-free Survival (PFS) Rate at 3 Months [ Time Frame: 12 weeks ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 21, 2008)
Progression-free survival (PFS) at 3 months [ Time Frame: Response assessment with CT scans using RECIST will be performed every 4 weeks until 12 weeks following randomization and then every 8 weeks until progression ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 14, 2012)
  • Progression-free Survival (PFS) [ Time Frame: Performed at baseline, every 4 weeks until Week 12 following randomization and then every 8 weeks until objective disease progression. ]
    Progression-free survival (PFS) defined as the median time from randomization to death from any cause or first observed disease progression.
  • Overall Survival (OS) [ Time Frame: Every 12 weeks unless the patient withdraws consent ]
    Overall survival (OS) defined as the median time from randomization to death from any cause.
  • Disease of Response (DOR) [ Time Frame: Performed at baseline, every 4 weeks until Week 12 following randomization and then every 8 weeks until objective disease progression. ]
    Number of patients showing Complete Response (CR), Partial Response (PR) or Stable Disease (SD) based on RECIST for the best response. Number of patients showing Complete Response (CR, disappearance of all target lesions), Partial Response (PR, at least a 30% decrease in the sum of longest diameter of target lesions taking as reference the baseline sum longest diameter) or Stable Disease (SD, Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum longest diameter since the treatment started) based on RECIST Criteria Version 1.0 (assessed by CT and/or MRI) for the best response
  • Objective Response Rate (ORR) [ Time Frame: Performed at baseline, every 4 weeks until Week 12 following randomization and then every 8 weeks until objective disease progression. ]
    Number of patients showing Complete Response (CR) or Partial Response (PR) based on RECIST for the best response. Number of patients showing Complete Response (CR, disappearance of all target lesions) or Partial Response (PR, at least a 30% decrease in the sum of longest diameter of target lesions taking as reference the baseline sum longest diameter) based on RECIST Criteria Version 1.0 (assessed by CT and/or MRI) for the best response.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 21, 2008)
  • Progression-free Survival (PFS) [ Time Frame: Response assessment with CT scans using RECIST will be performed every 4 weeks until 12 weeks following randomization and then every 8 weeks until progression ]
  • Overall survivial (OS) [ Time Frame: Assessment of survival will be checked every treament visit, follow-up visit and then every 12 weeks unless the patient withdraws consent. ]
  • Disease of Response (DOR) [ Time Frame: Response assessment with CT scans using RECIST will be performed every 4 weeks until 12 weeks following randomization and then every 8 weeks until progression ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase II of Zactima Maintenance for Locally Advanced or Metastatic Non-small-cell Lung Carcinoma (NSCLC) Following Platinum-doublet Chemotherapy
Official Title  ICMJE 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
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 in patients with locally advanced or metastatic NSCLC, who have received and responded to prior platinum-doublet systemic chemotherapy. The primary objective of the study is to compare the Progression Free Survival (PFS) rate at 3 months in locally advanced or metastatic NSCLC patients with or without vandetanib maintenance.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE NSCLC
Intervention  ICMJE
  • Drug: Vandetanib
    Tablet, oral, daily
    Other Name: Zactima TM
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: Vandetanib
    Intervention: Drug: Vandetanib
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 29, 2016)
117
Original Estimated Enrollment  ICMJE
 (submitted: October 21, 2008)
126
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00777179
Other Study ID Numbers  ICMJE D4200C00077
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi ( Genzyme, a Sanofi Company )
Study Sponsor  ICMJE Genzyme, a Sanofi Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi
PRS Account Sanofi
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP