ZD6474(Vandetanib) + Alimta Combo Study
A Phase I, Open-Label Study to Assess the Safety and Tolerability of ZD6474 in Combination With Pemetrexed (Alimta) in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer After Failure of Prior Chemotherapy.
1 other identifier
interventional
21
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jul 2005
Longer than P75 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 3, 2007
CompletedFirst Posted
Study publicly available on registry
July 25, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedAugust 25, 2016
August 1, 2016
10 months
July 3, 2007
August 24, 2016
Conditions
Keywords
Outcome Measures
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.
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.
assessed at each visit
Study Arms (2)
ZD6474 (vandetanib) 100mg
EXPERIMENTALZD6474 (vandetanib) 300mg
EXPERIMENTALInterventions
intravenous infusion
Eligibility Criteria
You may qualify if:
- Confirmed advanced or metastatic non-small cell lung cancer
- Failure of first-line chemotherapy
- or more measurable lesion by RECIST
You may not qualify if:
- Previous chemotherapy or radiotherapy within 4 weeks
- Significant cardiac events, arrythmias or other cardiac conditions
- Unacceptable laboratory measurements
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 19088171BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Sciences & Operations
Sanofi
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 3, 2007
First Posted
July 25, 2007
Study Start
July 1, 2005
Primary Completion
May 1, 2006
Study Completion
October 1, 2011
Last Updated
August 25, 2016
Record last verified: 2016-08