Advanced Adenocarcinoma of PancreasPhase 2NCT00913198
A Study of CP-4126 in Patients With Advanced Pancreatic Cancer
A Phase 2 study testing IV CP-4126 in people with Advanced Adenocarcinoma of Pancreas, run by Clavis Pharma at 3 sites in 2 countries.
Trial summary
The main objective of this study is to assess the biological activity of CP-4126 in patients with advanced pancreatic cancer. In addition, the correlation between hENT1 (human equilibrative nucleoside transporter 1) and overall survival will be studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Adenocarcinoma of Pancreas
- What is being tested?
- IV CP-4126
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Apr 2009to Sep 2011
- Phase
- Phase 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological or cytological confirmed advanced pancreatic cancer*
- Not eligible for curative resection
- Performance Status (ECOG) 0-2
- Estimated life expectancy of at least 12 weeks
- Age ≥ 18 years
- Adequate haematological and biological functions:
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- Neutrophils ≥ 1.5 x 109/L
- Platelets > 100.0 x 109/L
- Hb ≥ 10 g/dL
- AST/ALT and alkaline phosphatase (ALP) ≤ 2.5 x institutional upper limit of normal (ULN), if liver metastases
- AST/ALT ≤ 5 x institutional ULN and ALP ≤ 4 x institutional ULN
- Bilirubin ≤ 1.5 times institutional ULN, if liver metastases ≤ 3 x institutional ULN
- Serum creatinine ≤ 1.5 times institutional ULN
- Signed informed consent
Who cannot join
- Prior chemotherapy for metastatic disease
- Symptomatic brain metastases
- Participation in another therapeutic clinical study within 30 days of enrolment or during this clinical study
- Requirement of concomitant treatment with a non-permitted medication, including high doses of vitamins and alternative drugs
- History of allergic reactions to gemcitabine or egg
- Presence of any serious concomitant systemic disorders incompatible with the clinical study (e.g. uncontrolled inter-current illness including ongoing or active infection)
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- Presence of any significant central nervous system or psychiatric disorder(s) that would hamper the patient's compliance
- Pregnant or breastfeeding women
- Absence of adequate contraception for both male and female fertile patients for the duration of the study; and also for three months after last treatment
- Known positive status for HIV
- Any reason why, in the investigator's opinion, the patient should not participate in the study.
- Drug or alcohol abuse
- Prior radical resection, but exploratory laparotomy as well palliative (e.g bypass) surgery are allowed
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Norway2 sites
Oslo University Hospital, The Norwegian Radium Hospital,
Oslo, 0310
Oslo University Hospital, Ullevål
Oslo, 0407
Belgium1 site
Clinique d'Oncologie Médicale, Institut Jules Bordet
Brussels, 1000
About this study
Official title: A Phase II Study of CP-4126 in Patients With Advanced Pancreatic Cancer.
The main objective of this study is to assess the biological activity of CP-4126 in patients with advanced pancreatic cancer. In addition, the correlation between hENT1 (human equilibrative nucleoside transporter 1) and overall survival will be studied.
- Conditions
- Advanced Adenocarcinoma of Pancreas
- Being tested
- IV CP-4126
- Keywords
- Pancreas, Advanced adenocarcinoma, CP-4126
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV CP-4126Drug
1250 mg/m2/d, IV (in the vein) on day 1, 8 and 15 of each 4 week cycle. Number of Cycles: until progression or unacceptable toxicity develops.
| Study group | Role | What they receive |
|---|---|---|
| IV CP-4126 | Experimental | Not described Receives: Drug: IV CP-4126 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biological activity of CP-4126 in patients with advanced pancreatic cancer.
Measured: Every second cycle
Secondary outcomes (1)
Overall survival, Objective response rate.
Measured: Every second cycle - study length
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2009 (estimated)
- Study startApr 2009
- Primary completionJun 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Adenocarcinoma of PancreasStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clavis Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00913198
- Sponsor's protocol ID
- CP4126-201
- Status last verified
- Feb 2012
- First submitted
- 3 Jun 2009
- Last updated
- 10 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of CP-4126 in Patients With Advanced Pancreatic Cancer.
- ClinicalTrials.gov ID
- NCT00913198
- Acronym / sponsor ID
- CP4126-201
- Conditions
- Advanced Adenocarcinoma of Pancreas
- Keywords
- Pancreas, Advanced adenocarcinoma, CP-4126
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Clavis PharmaIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 4 Jun 2009 (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 objective of this study is to assess the biological activity of CP-4126 in patients with advanced pancreatic cancer. In addition, the correlation between hENT1 (human equilibrative nucleoside transporter 1) and overall survival will be studied.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IV CP-4126 | Experimental | Drug: IV CP-4126 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histological or cytological confirmed advanced pancreatic cancer*
- Not eligible for curative resection
- Performance Status (ECOG) 0-2
- Estimated life expectancy of at least 12 weeks
- Age ≥ 18 years
Key exclusion criteria (13 listed)
- Prior chemotherapy for metastatic disease
- Symptomatic brain metastases
- Participation in another therapeutic clinical study within 30 days of enrolment or during this clinical study
- Requirement of concomitant treatment with a non-permitted medication, including high doses of vitamins and alternative drugs
- History of allergic reactions to gemcitabine or egg
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 |
|---|---|---|
| IV CP-41261250 mg/m2/d, IV (in the vein) on day 1, 8 and 15 of each 4 week cycle. Number of Cycles: until progression or unacceptable toxicity develops. | Drug | IV CP-4126 |
Primary outcome
Biological activity of CP-4126 in patients with advanced pancreatic cancer.
Time frame: Every second cycle
1 secondary outcome
Overall survival, Objective response rate.
Time frame: Every second cycle - study length
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 10 Feb 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IV CP-4126 in people with Advanced Adenocarcinoma of Pancreas, run by Clavis Pharma at 3 sites in 2 countries.
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 14 inclusion and 13 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 10 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Norway, Belgium. 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 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?
Biological activity of CP-4126 in patients with advanced pancreatic cancer. (time frame: Every second cycle). 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 10 Feb 2012.