NCT00777179

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2008

Typical duration for phase_2

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

October 21, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 22, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

July 8, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

October 10, 2016

Status Verified

August 1, 2016

Enrollment Period

1.3 years

First QC Date

October 21, 2008

Results QC Date

April 27, 2011

Last Update Submit

August 29, 2016

Conditions

NSCLC

Keywords

Vandetanib, NSCLC, Maintenance, Phase II

Outcome Measures

Primary Outcomes (1)

  • Progression-free Survival (PFS) Rate at 3 Months

    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.

    12 weeks

Secondary Outcomes (4)

  • Progression-free Survival (PFS)

    Performed at baseline, every 4 weeks until Week 12 following randomization and then every 8 weeks until objective disease progression.

  • Overall Survival (OS)

    Every 12 weeks unless the patient withdraws consent

  • Disease of Response (DOR)

    Performed at baseline, every 4 weeks until Week 12 following randomization and then every 8 weeks until objective disease progression.

  • Objective Response Rate (ORR)

    Performed at baseline, every 4 weeks until Week 12 following randomization and then every 8 weeks until objective disease progression.

Study Arms (2)

Vandetanib

EXPERIMENTAL
Drug: Vandetanib

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

VandetanibDRUG

Tablet, oral, daily

Also known as: Zactima TM
Vandetanib
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Research Site

Cheongju-si, Republic of Korea, South Korea

Location

Research Site

Gyeonggi-do, Republic of Korea, South Korea

Location

Research Site

Gyeongsangnam-Do, Republic of Korea, South Korea

Location

Research Site

Incheon, Republic of Korea, South Korea

Location

Research Site

Seoul, Republic of Korea, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

vandetanib

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
Trial Transparency Team
Organization
Sanofi
Contact-US@sanofi.com

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2008

First Posted

October 22, 2008

Study Start

October 1, 2008

Primary Completion

January 1, 2010

Study Completion

December 1, 2011

Last Updated

October 10, 2016

Results First Posted

July 8, 2011

Record last verified: 2016-08

Locations

KR(5)