Pancreatic CancerPhase 1/2NCT00288925
Z-360 in Unresectable Advanced Pancreatic Cancer in Combination With Gemcitabine Treatment
A Phase 1/2 study testing Z-360 in people with Pancreatic Cancer, run by Zeria Pharmaceutical at 1 site in United Kingdom.
Trial summary
To evaluate the safety of two doses of Z-360 with Gemcitabine administration for subjects with unresectable advanced pancreatic cancer in order to determine the optimal dosage for PhaseII study Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Z-360
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2005to Dec 2007
- Phase
- Phase 1/2
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with unresectable locally advanced or metastatic pancreatic cancer
- KPS > 70%
- Life expectancy of at least 3 months
Who cannot join
- received previous chemotherapy for the current indication
- received previous radiotherapy for the current indication
- Currently receiving chemotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase Ib/IIa, to Evaluate the Safety and Pharmacokinetics of Z-360 in Subjects With Unresectable Advanced Pancreatic Cancer in Combination With Gemcitabine Treatment
To evaluate the safety of two doses of Z-360 with Gemcitabine administration for subjects with unresectable advanced pancreatic cancer in order to determine the optimal dosage for PhaseII study
- Conditions
- Pancreatic Cancer
- Being tested
- Z-360
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Z-360Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety, Pharmacokinetics
Secondary outcomes (1)
Tumour shrinkage, Tumour objective response rate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2006 (estimated)
- Study startSep 2005
- Primary completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Zeria Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Tim Meyer, PhD, MD, Principal investigator, Royal Free Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00288925
- Sponsor's protocol ID
- 01010106E
- Status last verified
- May 2009
- First submitted
- 6 Feb 2006
- Last updated
- 1 Jun 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib/IIa, to Evaluate the Safety and Pharmacokinetics of Z-360 in Subjects With Unresectable Advanced Pancreatic Cancer in Combination With Gemcitabine Treatment
- ClinicalTrials.gov ID
- NCT00288925
- Acronym / sponsor ID
- 01010106E
- Conditions
- Pancreatic Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- Zeria PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Dec 2007 (actual)
- First posted
- 8 Feb 2006 (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.
To evaluate the safety of two doses of Z-360 with Gemcitabine administration for subjects with unresectable advanced pancreatic cancer in order to determine the optimal dosage for PhaseII study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects with unresectable locally advanced or metastatic pancreatic cancer
- KPS > 70%
- Life expectancy of at least 3 months
Key exclusion criteria (3 listed)
- received previous chemotherapy for the current indication
- received previous radiotherapy for the current indication
- Currently receiving chemotherapy
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 |
|---|---|---|
| Z-360 | Drug | – |
Primary outcome
Safety, Pharmacokinetics
1 secondary outcome
Tumour shrinkage, Tumour objective response rate
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 1 Jun 2009.
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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.
Tim Meyer, PhD, MD principal investigator
Royal Free Hospital NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Z-360 in people with Pancreatic Cancer, run by Zeria Pharmaceutical at 1 site in United Kingdom.
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 1 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Safety, Pharmacokinetics. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jun 2009.