Metastatic Colorectal CancerPhase 1NCT00940758
Phase I and Pharmacokinetic Study of Biweekly PEP02 in mCRC Refractory to 1st-line Oxaliplatin Base Therapy
A Phase 1 study testing PEP02 in people with Metastatic Colorectal Cancer, run by PharmaEngine at 1 site in Taiwan.
Trial summary
The purpose of this study is to evaluate the dose-limiting toxicity (DLT), toxicity profile, maximum tolerated dose (MTD) and characterize the pharmacokinetics of biweekly PEP02 treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- PEP02
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2009to Jun 2014
- 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
- Histopathologically confirmed metastatic colorectal cancer
- Documented disease progression after first-line chemotherapy containing oxaliplatin
- Both genders, age 18 years
- ECOG performance status 0 or 1
- Adequate organ and marrow function
- Written informed consent to participate in the study
Who cannot join
- Have received irinotecan treatment
- With active CNS metastases (indicated by clinical symptoms, cerebral edema, steroid requirement, or progressive growth)
- With clinically significant gastrointestinal disorder (e.g. bleeding, inflammation, obstruction, including partial or complete obstruction secondary to peritoneal carcinomatosis, or diarrhea > grade 1)
- With uncontrolled intercurrent illness that could limit study compliance considered to be ineligible for the study by the investigators including, but NOT limited to, any of the following:ongoing or active infection requiring antibiotic treatment, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia psychiatric illness or social situation that would preclude study compliance
- With other primary malignancies, except those remain disease-free for 3 or more years after curative treatment.
- Prior chemotherapy within 3 weeks
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- Major surgery or radiotherapy within 4 weeks
- Prior participation in any investigational drug study within 3 weeks
- History of allergic reaction to liposome product
- Pregnant or breastfeeding (a urine pregnancy test must be performed on all patients who are of childbearing potential before entering the study, and the result must be negative)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I and Pharmacokinetic Study of Biweekly PEP02 (Liposome Irinotecan) in Patients With Metastatic Colorectal Cancer Refractory to First-line Oxaliplatin-based Chemotherapy
The purpose of this study is to evaluate the dose-limiting toxicity (DLT), toxicity profile, maximum tolerated dose (MTD) and characterize the pharmacokinetics of biweekly PEP02 treatment.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- PEP02
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEP02Drug
Dose escalation: 50-100 mg/m2 biweekly
| Study group | Role | What they receive |
|---|---|---|
| PEP02 | Experimental | Not described Receives: Drug: PEP02 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the DLT and the toxicity profile
Measured: 3 years
To establish the MTD
Measured: 3 years
To characterize the pharmacokinetics of biweekly PEP02 in patients with metastatic colorectal cancer who failed to first-line oxaliplatin-based chemotherapy
Measured: 3 years
Secondary outcomes (2)
To collect data for preliminary evaluation of tumor response
Measured: 3 years
To explore the association of the pharmacogenetics of PEP02 including UGT1A family - UGT1A1 and UGT1A9 with pharmacokinetic parameters and toxicity
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2009 (estimated)
- Study startJun 2009
- Primary completionMay 2012
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- PharmaEngine
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00940758
- Sponsor's protocol ID
- PIST-CRC-01
- Status last verified
- Apr 2017
- First submitted
- 15 Jul 2009
- Last updated
- 6 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I and Pharmacokinetic Study of Biweekly PEP02 (Liposome Irinotecan) in Patients With Metastatic Colorectal Cancer Refractory to First-line Oxaliplatin-based Chemotherapy
- ClinicalTrials.gov ID
- NCT00940758
- Acronym / sponsor ID
- PIST-CRC-01
- Conditions
- Metastatic Colorectal Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- PharmaEngineIndustry (pharma, biotech, devices)
- Study start
- Jun 2009 (actual)
- Primary completion
- May 2012 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 16 Jul 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 purpose of this study is to evaluate the dose-limiting toxicity (DLT), toxicity profile, maximum tolerated dose (MTD) and characterize the pharmacokinetics of biweekly PEP02 treatment.
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: PEP02 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histopathologically confirmed metastatic colorectal cancer
- Documented disease progression after first-line chemotherapy containing oxaliplatin
- Both genders, age 18 years
- ECOG performance status 0 or 1
- Adequate organ and marrow function
Key exclusion criteria (10 listed)
- Have received irinotecan treatment
- With active CNS metastases (indicated by clinical symptoms, cerebral edema, steroid requirement, or progressive growth)
- With clinically significant gastrointestinal disorder (e.g. bleeding, inflammation, obstruction, including partial or complete obstruction secondary to peritoneal carcinomatosis, or diarrhea > grade 1)
- With uncontrolled intercurrent illness that could limit study compliance considered to be ineligible for the study by the investigators including, but NOT limited to, any of the following:ongoing or active infection requiring antibiotic treatment, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia psychiatric illness or social situation that would preclude study compliance
- With other primary malignancies, except those remain disease-free for 3 or more years after curative 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 |
|---|---|---|
| PEP02Dose escalation: 50-100 mg/m2 biweekly | Drug | PEP02 |
Primary outcome
To evaluate the DLT and the toxicity profile
Time frame: 3 years
To establish the MTD
Time frame: 3 years
To characterize the pharmacokinetics of biweekly PEP02 in patients with metastatic colorectal cancer who failed to first-line oxaliplatin-based chemotherapy
Time frame: 3 years
2 secondary outcomes
To collect data for preliminary evaluation of tumor response
Time frame: 3 years
To explore the association of the pharmacogenetics of PEP02 including UGT1A family - UGT1A1 and UGT1A9 with pharmacokinetic parameters and toxicity
Time frame: 3 years
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 Apr 2017.
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CRC
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PEP02 in people with Metastatic Colorectal Cancer, run by PharmaEngine at 1 site in Taiwan.
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 6 inclusion and 10 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 Apr 2017. 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 Taiwan. 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?
To evaluate the DLT and the toxicity profile (time frame: 3 years). The study lists 3 primary outcomes in all. 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 6 Apr 2017.