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

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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 )

Study Description
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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.

Condition or disease Intervention/treatment Phase
NSCLC Drug: Vandetanib Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 117 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2008
Actual Primary Completion Date : January 2010
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Vandetanib

Arms and Interventions
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Arm Intervention/treatment
Experimental: Vandetanib Drug: Vandetanib
Tablet, oral, daily
Other Name: Zactima TM
Placebo Comparator: Placebo Drug: Placebo
Placebo


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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


  4. 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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00777179


Locations
Korea, Republic of
Research Site
CheongJu, Republic of Korea, Korea, Republic of
Research Site
Gyeonggi-do, Republic of Korea, Korea, Republic of
Research Site
Gyeongsangnam-Do, Republic of Korea, Korea, Republic of
Research Site
Incheon, Republic of Korea, Korea, Republic of
Research Site
Seoul, Republic of Korea, Korea, Republic of
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
Study Director: Clinical Sciences & Operations Sanofi
More Information
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Responsible Party: Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00777179     History of Changes
Other Study ID Numbers: D4200C00077
First Posted: October 22, 2008    Key Record Dates
Results First Posted: July 8, 2011
Last Update Posted: October 10, 2016
Last Verified: August 2016

Keywords provided by Sanofi ( Genzyme, a Sanofi Company ):
Vandetanib, NSCLC, Maintenance, Phase II

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms