Back to resultsZD6474(Vandetanib) + Alimta Combo Study
Primary Purpose
Carcinoma, Non-Small Cell Lung, Lung Cancer
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
ZD6474 (vandetanib) 100mg
pemetrexed
ZD6474 (vandetanib) 300mg
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma focused on measuring Non-small cell lung cancer, lung cancer, alimta, vandetanib, phase 1
Eligibility Criteria
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:
- Previous chemotherapy or radiotherapy within 4 weeks
- Significant cardiac events, arrythmias or other cardiac conditions
- Unacceptable laboratory measurements
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
ZD6474 (vandetanib) 100mg
ZD6474 (vandetanib) 300mg
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT00506051
First Posted
July 3, 2007
Last Updated
August 24, 2016
Sponsor
Genzyme, a Sanofi Company
1. Study Identification
Unique Protocol Identification Number
NCT00506051
Brief Title
ZD6474(Vandetanib) + Alimta Combo Study
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genzyme, a Sanofi Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small Cell Lung, Lung Cancer
Keywords
Non-small cell lung cancer, lung cancer, alimta, vandetanib, phase 1
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ZD6474 (vandetanib) 100mg
Arm Type
Experimental
Arm Title
ZD6474 (vandetanib) 300mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ZD6474 (vandetanib) 100mg
Other Intervention Name(s)
ZACTIMA™
Intervention Description
once daily oral tablet
Intervention Type
Drug
Intervention Name(s)
pemetrexed
Other Intervention Name(s)
Alimta®
Intervention Description
intravenous infusion
Intervention Type
Drug
Intervention Name(s)
ZD6474 (vandetanib) 300mg
Other Intervention Name(s)
ZACTIMA™
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
Previous chemotherapy or radiotherapy within 4 weeks
Significant cardiac events, arrythmias or other cardiac conditions
Unacceptable laboratory measurements
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
19088171
Citation
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.
Results Reference
background
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1428&filename=CSR-D4200C00041.pdf
Description
Related Info
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1428&filename=CSR-D4200C00041.pdf
Description
CSR-D4200C00041.pdf
Learn more about this trial
ZD6474(Vandetanib) + Alimta Combo Study
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