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Non Small Cell Lung CarcinomaPhase 2NCT00252746

ZD6474 Phase IIa Dose Finding Multicentre Study

A Phase 2 study testing ZD6474 (vandetanib) 100mg, ZD6474 (vandetanib) 200mg and ZD6474 (vandetanib) 300mg in people with Non Small Cell Lung Carcinoma, run by Genzyme, a Sanofi Company at 7 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To assess the objective response rates (by RECIST) to ZD6474 100, 200 and 300 mg/day respectively Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Non Small Cell Lung Carcinoma
What is being tested?
ZD6474 (vandetanib) 100mg, ZD6474 (vandetanib) 200mg and ZD6474 (vandetanib) 300mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
7 sitesJapan
Study dates
Dec 2004to Jan 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Provision of written informed consent.
  • Life expectancy of 12 weeks or longer.

Who cannot join

  • Pregnancy, breast feeding or female patients wishing to become pregnant.
  • Treatment with a non-approved or investigational drug within 30 days before enrolment

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Japan7 sites

  • Research Site

    Isehara, Kanagawa

  • Research Site

    Matsuyama, Ehime

  • Research Site

    Okayama, Okayama-ken

  • Research Site

    Sayama, Osaka

  • Research Site

    Sunto-gun, Shizuoka

  • Research Site

    Tokyo

  • Research Site

    Toyonaka, Osaka

Other trials in Japan

About this study

Official title: A Randomised, Double-blind, Parallel-group, Dose Finding Study to Assess the Efficacy and Safety of ZD6474 in Patients With Advanced, Metastatic, or Recurrent NSCLC Who Have Failed Previous Chemotherapy Regimens, at Least One of Which Contained Platinum [Title Abbreviated]

To assess the objective response rates (by RECIST) to ZD6474 100, 200 and 300 mg/day respectively

Being tested
ZD6474 (vandetanib) 100mg, ZD6474 (vandetanib) 200mg, ZD6474 (vandetanib) 300mg
Keywords
NSCLC, Non Small Cell Lung Cancer
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ZD6474 (vandetanib) 100mgDrug

    Also called ZACTIMA™

    once daily oral dose

  • ZD6474 (vandetanib) 200mgDrug

    Also called ZACTIMA

    once daily oral dose

  • ZD6474 (vandetanib) 300mgDrug

    Also called ZACTIMA

    once daily oral dose

Study groups in NCT00252746
Study groupRoleWhat they receive
ZD6474 100mgExperimentalDaily dose
Receives: Drug: ZD6474 (vandetanib) 100mg
ZD6474 200mgExperimentaldaily dose
Receives: Drug: ZD6474 (vandetanib) 200mg
ZD6474 300mgExperimentaldaily dose
Receives: Drug: ZD6474 (vandetanib) 300mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To assess the objective response rates (by RECIST) to ZD6474 100, 200 and 300 mg/day respectively

    Measured: Every 4 weeks for the first 24 weeks of treatment and then every 8 weeks until PD is determined or withdrawal due to any reasons other than PD. If PR or CR is observed, tumour assessment will be repeated 4 weeks after for confirmation of the response

Secondary outcomes (1)

  1. To assess the tolerability, safety, disease control rate, duration of response, time to progression, changes in quality of life and tumour-related and overall symptom improvements, and to characterise the PK and PK-PD relationship

    Tumour assessments to evaluate disease control rate, duration of response, time to progression will be performed every 4 weeks for the first 24 weeks of treatment, then every 8 weeks until PD is determined or withdrawal due to any reasons other than PD. If PR or CR is observed, tumour assessment will be repeated 4 weeks after for confirmation of the response. Quality of life questionnaire - FACT-L will be given to subjects at baseline and at 4-week intervals during the study treatment (up to Week 12). Lung cancer subscale (LCS) for disease-related symptoms collection will be completed weekly (up to Week 12). Safety and tolerability will be assessed on the ongoing basis by AZ collection, and at the site visits by vital sign, ECG and lab assessments. Blood sampling for pharmacokinetics will be performed on day 8, 15, 22, 29, 57 and 85. In the event of QTc prolongation, PK sampling will continue with the additional ECG monitoring performed until the QTc has fallen below 460 msec.

    Measured: Every 4 weeks till meeting discontinuation criteria

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2005 (estimated)
  2. Study startDec 2004
  3. Primary completionJan 2007
  4. Study completionJan 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00252746
Sponsor's protocol ID
D4200C00039
Status last verified
Aug 2016
First submitted
14 Nov 2005
Last updated
25 Aug 2016
Results posted
No

Publications

  • Kiura K, Nakagawa K, Shinkai T, Eguchi K, Ohe Y, Yamamoto N, Tsuboi M, Yokota S, Seto T, Jiang H, Nishio K, Saijo N, Fukuoka M. A randomized, double-blind, phase IIa dose-finding study of Vandetanib (ZD6474) in Japanese patients with non-small cell lung cancer. J Thorac Oncol. 2008 Apr;3(4):386-93. doi: 10.1097/JTO.0b013e318168d228.

    PubMed 18379357

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ZD6474 (vandetanib) 100mg, ZD6474 (vandetanib) 200mg and ZD6474 (vandetanib) 300mg in people with Non Small Cell Lung Carcinoma, run by Genzyme, a Sanofi Company at 7 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess the objective response rates (by RECIST) to ZD6474 100, 200 and 300 mg/day respectively (time frame: Every 4 weeks for the first 24 weeks of treatment and then every 8 weeks until PD is determined or withdrawal due to any reasons other than PD. If PR or CR is observed, tumour assessment will be repeated 4 weeks after for confirmation of the response). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00252746, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2016.

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