NCT00753714

Brief Summary

The primary objective of this study is to demonstrate an improvement in Progression-Free Survival (PFS) for the combination of vandetanib plus gemcitabine compared with gemcitabine plus placebo in chemonaïve (not including an adjuvant regimen) patients aged ≥ 70 years with advanced NSCLC.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
124

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2008

Typical duration for phase_2

Geographic Reach
1 country

15 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

First Submitted

Initial submission to the registry

September 15, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 16, 2008

Completed
15 days until next milestone

Study Start

First participant enrolled

October 1, 2008

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
10 months until next milestone

Results Posted

Study results publicly available

September 28, 2012

Completed
Last Updated

October 17, 2016

Status Verified

August 1, 2016

Enrollment Period

2.5 years

First QC Date

September 15, 2008

Results QC Date

August 29, 2012

Last Update Submit

August 30, 2016

Conditions

Non Small Cell Lung Cancer

Keywords

ZD6474VANDETANIBZACTIMAADVANCEDNSCLCLUNG CANCERELDERLY PATIENTSGEMCITABINEPHASE IIRANDOMIZEDDOUBLE-BLINDhistologically or cytologically-confirmed advanced (stage IIIB with supraclavicular lymph node metastases or pleural effusion or stage IV) NSCLC

Outcome Measures

Primary Outcomes (1)

  • Progression Free Survival

    Oct 2008- dec 2011

Secondary Outcomes (4)

  • Overall Survival

    Oct 2008- dec 2011

  • Overall Objective Response

    Oct 2008- dec 2011

  • Duration of Response

    Oct 2008- dec 2011

  • The Safety and Tolerability Profile of ZD6474 (Vandetanib) in Combination With Gemcitabine

    Oct 2008- Dec 2011

Study Arms (2)

A

EXPERIMENTAL

Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1.Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with vandetanib alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued.

Drug: ZD6474, VandetanibDrug: Gemcitabine

B

PLACEBO COMPARATOR

Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1.Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with placebo alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued.

Drug: Placebo to Match ZD6474, VandetanibDrug: Gemcitabine

Interventions

ZD6474, VandetanibDRUG

100 mg as a once daily oral dose, from Day 1 until disease progression or unacceptable toxicity or consent withdrawal whichever occurs first

Also known as: Zactima
A
Placebo to Match ZD6474, VandetanibDRUG

100 mg as a once daily oral dose, from Day 1 UNTIL disease progression or unacceptable toxicity or consent withdrawal whichever occurs first

Also known as: Zactima
B
GemcitabineDRUG

administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle UP to 6 cycles or UNTIL disease progression or unacceptable toxicity or consent withdrawal whichever occurs first

Also known as: Gemzar
AB

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Histologic or cytologic confirmation of advanced NSCLC (stage IIIB with supraclavicular lymph node metastases or pleural effusion or stage IV) on entry into study
  • One or more measurable lesions at least 10 mm in the longest diameter (LD) by spiral CT scan or 20 mm with conventional techniques according to RECIST criteria
  • Chemotherapy-naïve (prior chemotherapy in the adjuvant setting completed more than 3 months before the trial entry is accepted).
  • Female or male aged 70 years or above

You may not qualify if:

  • Patients must not have received prior anti-cancer therapy except in the adjuvant setting
  • Inadequate end-organ function or 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 trial
  • Significant cardiovascular event (e.g. myocardial infarction, superior vena cava \[SVC\] syndrome, New York Heart Association \[NYHA\] classification of heart disease ³2) within 3 months before entry, or presence of cardiac disease that in the opinion of
  • History of arrhythmia or QTc with Bazett's correction unmeasurable or ≥ 480 msec on screening ECG

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Research Site

Meldola, (fc), Italy

Location

Research Site

Avellino, AV, Italy

Location

Research Site

Bari, BA, Italy

Location

Research Site

Treviglio, BG, Italy

Location

Research Site

Bologna, BO, Italy

Location

Research Site

Genova, GE, Italy

Location

Research Site

Taormina, ME, Italy

Location

Research Site

Milan, MI, Italy

Location

Research Site

Perugia, PG, Italy

Location

Research Site

Ravenna, RA, Italy

Location

Research Site

Roma, Roma, Italy

Location

Research Site

Trento, TN, Italy

Location

Research Site

Orbassano, TO, Italy

Location

Research Site

Udine, UD, Italy

Location

Research Site

Padua, Italy

Location

Related Publications (1)

  • Gridelli C. Treatment of advanced non small-cell lung cancer in the elderly: from best supportive care to the combination of platin-based chemotherapy and targeted therapies. J Clin Oncol. 2008 Jan 1;26(1):13-5. doi: 10.1200/JCO.2007.14.1820. No abstract available.

    PMID: 18165633BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungLung NeoplasmsPleural Effusion

Interventions

vandetanibGemcitabine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

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
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2008

First Posted

September 16, 2008

Study Start

October 1, 2008

Primary Completion

April 1, 2011

Study Completion

December 1, 2011

Last Updated

October 17, 2016

Results First Posted

September 28, 2012

Record last verified: 2016-08

Locations

IT(15)