CClinicalTrials.gg
CompletedNCT00506051Updated Aug 25, 2016

ZD6474(Vandetanib) + Alimta Combo Study

A Phase 1 interventional study of ZD6474 (vandetanib) 100mg and pemetrexed in Carcinoma, Non-Small Cell Lung and Lung Cancer, sponsored by Genzyme, a Sanofi Company. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-08-25.

Sponsored by Genzyme, a Sanofi Company · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
21
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

The main purpose of this trial is to look to see if adding ZD6474 (100 mg or 300mg tablets) to Alimta chemotherapy in patients with non-small cell lung cancer is safe and will help control their symptoms and disease better than the chemotherapy alone.

02

Conditions studied

  • Carcinoma
  • Non-Small Cell Lung
  • Lung Cancer

Browse trials for

Keywords

  • Non-small cell lung cancer
  • lung cancer
  • alimta
  • vandetanib
  • phase 1
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 21 is below 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
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Confirmed advanced or metastatic non-small cell lung cancer
  • Failure of first-line chemotherapy
  • 1 or more measurable lesion by RECIST

Exclusion criteria

Exclusion Criteria:

  • Previous chemotherapy or radiotherapy within 4 weeks
  • Significant cardiac events, arrythmias or other cardiac conditions
  • Unacceptable laboratory measurements
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
21 participants (actual)

Study arms

  • Experimental
    ZD6474 (vandetanib) 100mg

    Drug: ZD6474 (vandetanib) 100mg · Drug: pemetrexed

  • Experimental
    ZD6474 (vandetanib) 300mg

    Drug: pemetrexed · Drug: ZD6474 (vandetanib) 300mg

Interventions

  • DrugZD6474 (vandetanib) 100mg

    once daily oral tablet

    Also known as: ZACTIMA™

  • Drugpemetrexed

    intravenous infusion

    Also known as: Alimta®

  • DrugZD6474 (vandetanib) 300mg

    Also known as: ZACTIMA™

06

What researchers measure

Primary outcomes

  1. To establish the safety & tolerability of ZD6474 when administered in combination w/Pemetrexed (Alimta) to patients w/locally advanced or metastatic NSCLC after failure of prior chemo, by assessment of AEs, vital signs, lab, ECG and physical exam.

    Time frame: assessed at each visit

Secondary outcomes

  1. To investigate the pharmacokinetics of ZD6474 and Pemetrexed when given in combination to patients with locally advanced or metastatic NSCLC after failure of prior chemotherapy, by assessment of appropriate pharmacokinetic (PK) parameters.

    Time frame: assessed at each visit

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • de Boer R, Humblet Y, Wolf J, Nogova L, Ruffert K, Milenkova T, Smith R, Godwood A, Vansteenkiste J. An open-label study of vandetanib with pemetrexed in patients with previously treated non-small-cell lung cancer. Ann Oncol. 2009 Mar;20(3):486-91. doi: 10.1093/annonc/mdn674. Epub 2008 Dec 16. PubMed 19088171 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 25, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00506051
Lead sponsor
Genzyme, a Sanofi Company
Responsible party
Sponsor
First posted
Jul 25, 2007
Start date
Jul 2005
Primary completion
May 2006
Completion
Oct 2011
Last update
Aug 25, 2016

Study contacts

Clinical Sciences & Operations
study director · Sanofi

Oversight

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

Not currently enrolling

This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion