Pancreatic CancerPhase 1NCT00681798
Dose Escalation Study With Zactima and Chemotherapy in Metastatic Pancreas Carcinoma
A Phase 1 study testing Vandetanib in people with Pancreatic Cancer, run by Sanofi at 2 sites in Switzerland.
Trial summary
The purpose of this study is to define th Maximum Tolerated Dose (MTD) and the recommended dose (RD) of ZD6474 in combination with a fixed standard dose of gemcitabine and capecitabine Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Vandetanib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Jul 2006to Jun 2009
- 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 diagnosis of locally advanced unresectable or metastatic pancreatic adenocarcinoma
- ECOG performance status <1
- Measurable disease
Who cannot join
- Severe or uncontrolled systemic disease
- Clinically significant cardiac event such as myocardial infarction
- Any concomitant medication that may cause OTc prolongation, include Torsades de Pointes
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Research Site
Bellinzona
Research Site
Sankt Gallen, Canton of St. Gallen
About this study
Official title: Dose Escalation Study of the Combination of ZD6474, Gemcitabine and Capecitabine in Locally Advanced Unresectable or Metastatic Pancreatic Adenocarcinoma
The purpose of this study is to define th Maximum Tolerated Dose (MTD) and the recommended dose (RD) of ZD6474 in combination with a fixed standard dose of gemcitabine and capecitabine
- Conditions
- Pancreatic Cancer
- Being tested
- Vandetanib
- Keywords
- pancreatic cancer, pancreatic adenocarcinoma, pancreas cancer, dose escalation study, locally advanced unresectable pancreatic adenocarcinoma, Zactima, Vandetanib, ZD6474
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VandetanibDrug
Also called Zactima
100mg/300mg
| Study group | Role | What they receive |
|---|---|---|
| Dose level 1 | Active comparator | Vandetanib 100mg/day plus Gemcitabine Receives: Drug: Vandetanib |
| Dose level 2 | Active comparator | Vandetanib 300mg/day plus Gemcitabine Receives: Drug: Vandetanib |
| Dose level 3 | Active comparator | Vandetanib 100mg/day plus Gemcitabine plus CapecitabineDose Receives: Drug: Vandetanib |
| Dose level 4 | Active comparator | Vandetanib 300mg/day plus Gemcitabine plus CapectiabineDose Receives: Drug: Vandetanib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Define Maximum Tolerated Dose (MTD)
Measured: during whole study
Define Recommended Dose (RD)
Measured: during whole study
Secondary outcomes (2)
Evaluate safety profile
Measured: during whole study
Determine antitumour activity as determined by overall response rate (RR), progression free survival (PFS), disease control rate and duration of response
Measured: every 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2008 (estimated)
- Study startJul 2006
- Primary completionJun 2009
- Study completionJun 2009
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 Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- 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
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00681798
- Sponsor's protocol ID
- D4200L00003
- Status last verified
- Aug 2016
- First submitted
- 20 May 2008
- Last updated
- 29 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Saletti P, Sessa C, De Dosso S, Cerny T, Renggli V, Koeberle D. Phase I dose-finding study of vandetanib in combination with gemcitabine in locally advanced unresectable or metastatic pancreatic adenocarcinoma. Oncology. 2011;81(1):50-4. doi: 10.1159/000330769. Epub 2011 Sep 15.
PubMed 21921646
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Escalation Study of the Combination of ZD6474, Gemcitabine and Capecitabine in Locally Advanced Unresectable or Metastatic Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT00681798
- Acronym / sponsor ID
- D4200L00003
- Conditions
- Pancreatic Cancer
- Keywords
- pancreatic cancer, pancreatic adenocarcinoma, pancreas cancer, dose escalation study, locally advanced unresectable pancreatic adenocarcinoma, Zactima, Vandetanib, ZD6474
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 21 May 2008 (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 purpose of this study is to define th Maximum Tolerated Dose (MTD) and the recommended dose (RD) of ZD6474 in combination with a fixed standard dose of gemcitabine and capecitabine
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose level 1 | Active comparator | Drug: VandetanibVandetanib 100mg/day plus Gemcitabine |
| Dose level 2 | Active comparator | Drug: VandetanibVandetanib 300mg/day plus Gemcitabine |
| Dose level 3 | Active comparator | Drug: VandetanibVandetanib 100mg/day plus Gemcitabine plus CapecitabineDose |
| Dose level 4 | Active comparator | Drug: VandetanibVandetanib 300mg/day plus Gemcitabine plus CapectiabineDose |
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 diagnosis of locally advanced unresectable or metastatic pancreatic adenocarcinoma
- ECOG performance status <1
- Measurable disease
Key exclusion criteria (3 listed)
- Severe or uncontrolled systemic disease
- Clinically significant cardiac event such as myocardial infarction
- Any concomitant medication that may cause OTc prolongation, include Torsades de Pointes
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 |
|---|---|---|
| VandetanibAlso: Zactima100mg/300mg | Drug | Dose level 1, Dose level 2, Dose level 3, Dose level 4 |
Primary outcome
Define Maximum Tolerated Dose (MTD)
Time frame: during whole study
Define Recommended Dose (RD)
Time frame: during whole study
2 secondary outcomes
Evaluate safety profile
Time frame: during whole study
Determine antitumour activity as determined by overall response rate (RR), progression free survival (PFS), disease control rate and duration of response
Time frame: every 2 months
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 29 Aug 2016.
- Background: PubMed 21921646Saletti P, Sessa C, De Dosso S, Cerny T, Renggli V, Koeberle D. Phase I dose-finding study of vandetanib in combination with gemcitabine in locally advanced unresectable or metastatic pancreatic adenocarcinoma. Oncology. 2011;81(1):50-4. doi: 10.1159/000330769. Epub 2011 Sep 15.
- D4200L00003 CSR SynopsisLink 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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vandetanib in people with Pancreatic Cancer, run by Sanofi at 2 sites in Switzerland.
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 29 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 2 sites in Switzerland. 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 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?
Define Maximum Tolerated Dose (MTD) (time frame: during whole study). The study lists 2 primary outcomes in all. 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 NCT00681798, 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 29 Aug 2016.