Pancreatic NeoplasmsPhase 2NCT00813163
Study of PEP02 as a Second Line Therapy for Metastatic Pancreatic Cancer
A Phase 2 study testing PEP02 in people with Pancreatic Neoplasms, run by PharmaEngine at 3 sites in 2 countries.
Trial summary
The purpose of this study is to see the effect of PEP02 in the treatment of metastatic pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Neoplasms
- What is being tested?
- PEP02
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jan 2009to Jul 2012
- 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
- Histologically or cytologically confirmed adenocarcinoma of exocrine pancreas
- Metastatic disease
- Documented disease progression after treatment with 1 line of prior gemcitabine-based regimen
- Karnofsky performance status equal or more than 70
Who cannot join
- With active CNS metastases
- With clinically significant gastrointestinal disorder (e.g., bleeding, inflammation, occlusion, or diarrhea > grade 1)
- Major surgery or radiotherapy within 4 weeks
- Prior participation in any investigational drug study within 4 weeks
- With prior irinotecan treatment
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Taiwan2 sites
National Health Research Institutes/National Chen-Kung Uiversity Hospital
Tainan, 704
National Taiwan University Hospital
Taipei, 100
United States1 site
Comprehensive Cancer Center, UCSF
San Francisco, California, 94115
About this study
Official title: A Phase II Study of PEP02 as a Second Line Therapy for Patients With Metastatic Pancreatic Cancer
The purpose of this study is to see the effect of PEP02 in the treatment of metastatic pancreatic cancer.
Read the detailed description
Gemcitabine monotherapy or a gemcitabine-based combination regimen is the standard first line therapy for advanced pancreatic cancer. After disease progression, there is no standard treatment available. In animal studies and a previous phase I trial, PEP02 has shown anti-tumor activity and preliminary efficacy in pancreatic cancer. In addition, a phase II study of free-form irinotecan single agent has already shown encouraging activity as second-line treatment for patients with advanced pancreatic cancer refractory to gemcitabine. The liposome formulation of PEP02 theoretically has therapeutic advantages over free-form irinotecan, such as site-specific delivery and extended release of drug. Hence PEP02 may be able to provide better efficacy than free-form irinotecan.
The primary purpose of this phase II study is to evaluate the activity of PEP02 as a second-line therapy in patients with metastatic pancreatic cancer failed to gemcitabine treatment. The primary goal is to measure the 3-month survival rate. An optimal Simon's 2-stage design will be used for this exploratory phase II study.
- Conditions
- Pancreatic Neoplasms
- Being tested
- PEP02
- Keywords
- Phase II study, Second line, Pancreatic cancer, Metastatic
- Medical subject headings
- Pancreatic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEP02Drug
Also called Liposome irinotecan
120 mg/m2, IV infusion for 90 minutes on day 1 of each 21 days as a treatment cycle.
Number of Cycles: until progression or unacceptable toxicity develops.
| Study group | Role | What they receive |
|---|---|---|
| PEP02 | Experimental | Liposome Irinotecan Receives: Drug: PEP02 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival Rate
Survival rate at 3 months
Measured: 3-month
Secondary outcomes (3)
other efficacy endpoints
objective tumor response, PFS, duration of response, overall survival, tumor marker response of CA19-9, clinical benefit response
Measured: 6-8 weeks
toxicities
All adverse events
Measured: 36 months
pharmacogenetics
UGT1A1 polymorphism
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2008 (estimated)
- Study startJan 2009
- Primary completionDec 2010
- Study completionJul 2012
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 NeoplasmsStudies 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
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- PharmaEngine
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Li-Tzong Chen, M.D., Principal investigator, National Health Research Institutes, TaiwanAndrew H Ko, M.D., Principal investigator, University of California, San FranciscoYu-Lin Lin, M.D., Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00813163
- Sponsor's protocol ID
- PEP0208
- Status last verified
- Aug 2019
- First submitted
- 18 Dec 2008
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Ko AH, Tempero MA, Shan YS, Su WC, Lin YL, Dito E, Ong A, Wang YW, Yeh CG, Chen LT. A multinational phase 2 study of nanoliposomal irinotecan sucrosofate (PEP02, MM-398) for patients with gemcitabine-refractory metastatic pancreatic cancer. Br J Cancer. 2013 Aug 20;109(4):920-5. doi: 10.1038/bjc.2013.408. Epub 2013 Jul 23.
PubMed 23880820
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of PEP02 as a Second Line Therapy for Patients With Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT00813163
- Acronym / sponsor ID
- PEP0208
- Conditions
- Pancreatic Neoplasms
- Keywords
- Phase II study, Second line, Pancreatic cancer, Metastatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- PharmaEngineIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 22 Dec 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 see the effect of PEP02 in the treatment of metastatic pancreatic cancer.
Detailed description
Gemcitabine monotherapy or a gemcitabine-based combination regimen is the standard first line therapy for advanced pancreatic cancer. After disease progression, there is no standard treatment available. In animal studies and a previous phase I trial, PEP02 has shown anti-tumor activity and preliminary efficacy in pancreatic cancer. In addition, a phase II study of free-form irinotecan single agent has already shown encouraging activity as second-line treatment for patients with advanced pancreatic cancer refractory to gemcitabine. The liposome formulation of PEP02 theoretically has therapeutic advantages over free-form irinotecan, such as site-specific delivery and extended release of drug. Hence PEP02 may be able to provide better efficacy than free-form irinotecan.
The primary purpose of this phase II study is to evaluate the activity of PEP02 as a second-line therapy in patients with metastatic pancreatic cancer failed to gemcitabine treatment. The primary goal is to measure the 3-month survival rate. An optimal Simon's 2-stage design will be used for this exploratory phase II study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PEP02 | Experimental | Drug: PEP02Liposome Irinotecan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically or cytologically confirmed adenocarcinoma of exocrine pancreas
- Metastatic disease
- Documented disease progression after treatment with 1 line of prior gemcitabine-based regimen
- Karnofsky performance status equal or more than 70
Key exclusion criteria (5 listed)
- With active CNS metastases
- With clinically significant gastrointestinal disorder (e.g., bleeding, inflammation, occlusion, or diarrhea > grade 1)
- Major surgery or radiotherapy within 4 weeks
- Prior participation in any investigational drug study within 4 weeks
- With prior irinotecan treatment
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 |
|---|---|---|
| PEP02Also: Liposome irinotecan120 mg/m2, IV infusion for 90 minutes on day 1 of each 21 days as a treatment cycle. Number of Cycles: until progression or unacceptable toxicity develops. | Drug | PEP02 |
Primary outcome
Survival Rate
Time frame: 3-month
Survival rate at 3 months
3 secondary outcomes
other efficacy endpoints
Time frame: 6-8 weeks
toxicities
Time frame: 36 months
pharmacogenetics
Time frame: 24 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 6 Sep 2019.
- Derived from this study: PubMed 23880820Ko AH, Tempero MA, Shan YS, Su WC, Lin YL, Dito E, Ong A, Wang YW, Yeh CG, Chen LT. A multinational phase 2 study of nanoliposomal irinotecan sucrosofate (PEP02, MM-398) for patients with gemcitabine-refractory metastatic pancreatic cancer. Br J Cancer. 2013 Aug 20;109(4):920-5. doi: 10.1038/bjc.2013.408. Epub 2013 Jul 23.
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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.
Li-Tzong Chen, M.D. principal investigator
National Health Research Institutes, Taiwan
Andrew H Ko, M.D. principal investigator
University of California, San Francisco
Yu-Lin Lin, M.D. principal investigator
National Taiwan University Hospital
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 PEP02 in people with Pancreatic Neoplasms, run by PharmaEngine 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 4 inclusion and 5 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 6 Sep 2019. 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 Taiwan, United States. 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?
Survival Rate (time frame: 3-month). 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 NCT00813163, 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 6 Sep 2019.