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CompletedNCT00753714ZELIGUpdated Oct 17, 2016Results posted

Zactima in Non Small Cell Lung Cancer (NSCLC) ELderly Patients In Combination With or Versus Gemcitabine

A Phase 2 interventional study of ZD6474, Vandetanib and Placebo to Match ZD6474, Vandetanib in Non Small Cell Lung Cancer, sponsored by Genzyme, a Sanofi Company. Completed at 15 sites in Italy. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2016-10-17.

Sponsored by Genzyme, a Sanofi Company · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
124
Allocation
Randomized
Ages
70 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Non Small Cell Lung Cancer

Keywords

  • ZD6474
  • VANDETANIB
  • ZACTIMA
  • ADVANCED
  • NSCLC
  • LUNG CANCER
  • ELDERLY PATIENTS
  • GEMCITABINE
  • PHASE II
  • RANDOMIZED
  • DOUBLE-BLIND
  • histologically or cytologically-confirmed advanced (stage IIIB with supraclavicular lymph node metastases or pleural effusion or stage IV) NSCLC
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 124 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Genzyme, a Sanofi Company is the lead sponsor of 303 studies on the registry; 5 are open to participants now.

Of its 24 completed or terminated interventional studies of FDA-regulated products, 19 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
70 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
124 participants (actual)

Study arms

  • Experimental
    A

    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, Vandetanib · Drug: Gemcitabine

  • Placebo comparator
    B

    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, Vandetanib · Drug: Gemcitabine

Interventions

  • DrugZD6474, Vandetanib

    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

  • DrugPlacebo to Match ZD6474, Vandetanib

    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

  • DrugGemcitabine

    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

06

What researchers measure

Primary outcomes

  1. Progression Free Survival

    Time frame: Oct 2008- dec 2011

Secondary outcomes

  1. Overall Survival

    Time frame: Oct 2008- dec 2011

  2. Overall Objective Response

    Time frame: Oct 2008- dec 2011

  3. Duration of Response

    Time frame: Oct 2008- dec 2011

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

    The Safety and Tolerability Profile of ZD6474 (Vandetanib) in Combination With Gemcitabine is defined as the number of Adverse Events which includes any symptoms and/or Clinically Significant Laboratory or Vital Signs Abnormalities, and/or ECGs Changes

    Time frame: Oct 2008- Dec 2011

07

Results

Posted Sep 28, 2012

Participant flow

A total of 124 patients have been enrolled in a period of 19 months in 17 actively recruiting Oncologic Medical Department in Italy.

Participant flow — Overall Study
MilestoneZD6474 (Vandetanib),GemcitabinePlacebo to Match ZD6474 (Vandetanib),Gemcitabine
Started6163
Completed11
Not completed6062
Withdrew: Lack of efficacy2134
Withdrew: Adverse event2618
Withdrew: Protocol violation10
Withdrew: Lost to follow-up01
Withdrew: Withdrawal by subject21
Withdrew: Death33
Withdrew: Other75

Outcome measures

PrimaryProgression Free Survival
Time frame:
Oct 2008- dec 2011
Reported as:
Median · days
Progression Free Survival
daysZD6474 (Vandetanib),GemcitabinePlacebo to Match ZD6474 (Vandetanib),Gemcitabine
Progression Free Survival183 (116 to 214)169 (95 to 194)
SecondaryOverall Survival
Time frame:
Oct 2008- dec 2011
Reported as:
Median · days
Overall Survival
daysZD6474 (Vandetanib),GemcitabinePlacebo to Match ZD6474 (Vandetanib),Gemcitabine
Overall Survival262 (170 to 356)305 (214 to 355)
SecondaryOverall Objective Response
Time frame:
Oct 2008- dec 2011
Reported as:
Number · Participants
Overall Objective Response
ParticipantsZD6474 ( (Vandetanib),GemcitabinePlacebo to Match ZD6474 (Vandetanib),Gemcitabine
Overall Objective Response98
SecondaryDuration of Response
Time frame:
Oct 2008- dec 2011
Reported as:
Median · days
Duration of Response
daysZD6474 (Vandetanib),GemcitabinePlacebo to Match ZD6474 (Vandetanib),Gemcitabine
Duration of Response225 (175 to NA)214 (124 to 232)
SecondaryThe Safety and Tolerability Profile of ZD6474 (Vandetanib) in Combination With Gemcitabine

The Safety and Tolerability Profile of ZD6474 (Vandetanib) in Combination With Gemcitabine is defined as the number of Adverse Events which includes any symptoms and/or Clinically Significant Laboratory or Vital Signs Abnormalities, and/or ECGs Changes

Time frame:
Oct 2008- Dec 2011
Reported as:
Number · Adverse Events
The Safety and Tolerability Profile of ZD6474 (Vandetanib) in Combination With Gemcitabine
Adverse EventsZD6474 (Vandetanib),GemcitabinePlacebo to Match ZD6474 (Vandetanib),Gemcitabine
The Safety and Tolerability Profile of ZD6474 (Vandetanib) in Combination With Gemcitabine378381

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
ZD6474 (Gemcitabine), Vandetanib—26/61 (42.6%)59/61 (96.7%)
Placebo to Match ZD6474 (Gemcitabine), Vandetanib—25/63 (39.7%)62/63 (98.4%)
Most frequent serious events
Showing 10 of 46
Most frequent serious events
EventZD6474 (Gemcitabine), VandetanibPlacebo to Match ZD6474 (Gemcitabine), Vandetanib
DyspnoeaRespiratory, thoracic and mediastinal disorders3/619/63
Pulmunary embolismRespiratory, thoracic and mediastinal disorders3/613/63
PyrexiaGeneral disorders0/613/63
PneumonitisRespiratory, thoracic and mediastinal disorders2/610/63
Pulmunary OedemaRespiratory, thoracic and mediastinal disorders2/610/63
respiratory failureRespiratory, thoracic and mediastinal disorders2/611/63
PneumoniaInfections and infestations2/611/63
Renal FailureRenal and urinary disorders2/610/63
Cerebral IschemiaNervous system disorders0/612/63
acute pulmunary oedemaRespiratory, thoracic and mediastinal disorders1/610/63
Most frequent other events
Showing 10 of 28
Most frequent other events
EventZD6474 (Gemcitabine), VandetanibPlacebo to Match ZD6474 (Gemcitabine), Vandetanib
DispnoeaRespiratory, thoracic and mediastinal disorders13/6119/63
pyrexiaGeneral disorders17/6117/63
AnorexiaMetabolism and nutrition disorders8/6117/63
RashSkin and subcutaneous tissue disorders15/615/63
FatigueGeneral disorders14/6115/63
Chest PainGeneral disorders2/6115/63
AnaemiaBlood and lymphatic system disorders8/6114/63
AstheniaGeneral disorders9/6113/63
NeutropeniaBlood and lymphatic system disorders12/6112/63
Oedema PeripheralGeneral disorders4/6112/63

Baseline characteristics

Age, Continuous
Age, Continuous(years)ZD6474 (Vandetanib),GemcitabinePlacebo to Match ZD6474 (Vandetanib),GemcitabineTotal
Mean75.03 ± 3.3475.48 ± 3.4975.25 ± 3.41
Sex: Female, Male
Sex: Female, Male(Participants)ZD6474 (Vandetanib),GemcitabinePlacebo to Match ZD6474 (Vandetanib),GemcitabineTotal
Female161834
Male454590
08

Study locations

15 sites
  • Research Site
    Meldola, (fc), Italy
  • Research Site
    Avellino, AV, Italy
  • Research Site
    Bari, BA, Italy
  • Research Site
    Treviglio, BG, Italy
  • Research Site
    Bologna, BO, Italy
  • Research Site
    Genova, GE, Italy
  • Research Site
    Taormina, ME, Italy
  • Research Site
    Milano, MI, Italy
  • Research Site
    Perugia, PG, Italy
  • Research Site
    Ravenna, RA, Italy
  • Research Site
    Trento, TN, Italy
  • Research Site
    Orbassano, TO, Italy
  • Research Site
    Udine, UD, Italy
  • Research Site
    Padova, Italy
  • Research Site
    Roma, Italy
09

References and documents

Publications

  • 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. PubMed 18165633 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 17, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00753714
Lead sponsor
Genzyme, a Sanofi Company
Responsible party
Sponsor
First posted
Sep 16, 2008
Start date
Oct 2008
Primary completion
Apr 2011
Completion
Dec 2011
Results posted
Sep 28, 2012
Last update
Oct 17, 2016

Study contacts

Clinical Sciences & Operations
study director · Sanofi

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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