CarcinomaPhase 1NCT00506051
ZD6474(Vandetanib) + Alimta Combo Study
A Phase 1 study testing ZD6474 (vandetanib) 100mg, pemetrexed and ZD6474 (vandetanib) 300mg in people with Carcinoma and Non-Small Cell Lung, run by Genzyme, a Sanofi Company.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small Cell Lung, Lung Cancer
- What is being tested?
- ZD6474 (vandetanib) 100mg, pemetrexed and ZD6474 (vandetanib) 300mg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- Jul 2005to Oct 2011
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed advanced or metastatic non-small cell lung cancer
- Failure of first-line chemotherapy
- 1 or more measurable lesion by RECIST
Who cannot join
- Previous chemotherapy or radiotherapy within 4 weeks
- Significant cardiac events, arrythmias or other cardiac conditions
- Unacceptable laboratory measurements
About this 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.
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.
- Conditions
- Carcinoma, Non-Small Cell Lung, Lung Cancer
- Being tested
- ZD6474 (vandetanib) 100mg, pemetrexed, ZD6474 (vandetanib) 300mg
- Keywords
- Non-small cell lung cancer, lung cancer, alimta, vandetanib, phase 1
- Medical subject headings
- Carcinoma, Lung Neoplasms, 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 tablet
pemetrexedDrug
Also called Alimta®
intravenous infusion
ZD6474 (vandetanib) 300mgDrug
Also called ZACTIMA™
| Study group | Role | What they receive |
|---|---|---|
| ZD6474 (vandetanib) 100mg | Experimental | Not described Receives: Drug: ZD6474 (vandetanib) 100mg; Drug: pemetrexed |
| ZD6474 (vandetanib) 300mg | Experimental | Not described Receives: Drug: pemetrexed; Drug: ZD6474 (vandetanib) 300mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: assessed at each visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2007 (estimated)
- Study startJul 2005
- Primary completionMay 2006
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00506051
- Sponsor's protocol ID
- D4200C00041
- Status last verified
- Aug 2016
- First submitted
- 3 Jul 2007
- Last updated
- 25 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00506051
- Acronym / sponsor ID
- D4200C00041
- Conditions
- Carcinoma, Non-Small Cell Lung, Lung Cancer
- Keywords
- Non-small cell lung cancer, lung cancer, alimta, vandetanib, phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Primary completion
- May 2006 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 25 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ZD6474 (vandetanib) 100mg | Experimental | Drug: ZD6474 (vandetanib) 100mg, Drug: pemetrexed |
| ZD6474 (vandetanib) 300mg | Experimental | Drug: pemetrexed, Drug: ZD6474 (vandetanib) 300mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Confirmed advanced or metastatic non-small cell lung cancer
- Failure of first-line chemotherapy
- 1 or more measurable lesion by RECIST
Key exclusion criteria (3 listed)
- Previous chemotherapy or radiotherapy within 4 weeks
- Significant cardiac events, arrythmias or other cardiac conditions
- Unacceptable laboratory measurements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZD6474 (vandetanib) 100mgAlso: ZACTIMA™once daily oral tablet | Drug | ZD6474 (vandetanib) 100mg |
| pemetrexedAlso: Alimta®intravenous infusion | Drug | ZD6474 (vandetanib) 100mg, ZD6474 (vandetanib) 300mg |
| ZD6474 (vandetanib) 300mgAlso: ZACTIMA™ | Drug | ZD6474 (vandetanib) 300mg |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2016.
- Background: PubMed 19088171de 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.
- Related InfoLink provided by the sponsor.
- CSR-D4200C00041.pdfLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ZD6474 (vandetanib) 100mg, pemetrexed and ZD6474 (vandetanib) 300mg in people with Carcinoma and Non-Small Cell Lung, run by Genzyme, a Sanofi Company.
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 3 inclusion and 3 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.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 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). 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 NCT00506051, 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.