Pancreatic CancerPhase 1NCT00882973
Trial to Determine the Maximum Tolerated Dose of Genexol-PM Plus Gemcitabine and Evaluate Efficacy and Safety of Genexol-PM Regimens in Subjects With Advanced Pancreatic Cancer
A Phase 1 study testing Genexol-PM in people with Pancreatic Cancer, run by Samyang Biopharmaceuticals Corporation.
Trial summary
This is a phase I/II trial to determine the maximum tolerated dose and recommended phase II dose of the combination therapy with Genexol-PM and gemcitabine (hereafter Genexol-PM plus gemcitabine) and to evaluate the efficacy and safety of Genexol-PM regimens (monotherapy and combination with gemcitabine) and… 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?
- Genexol-PM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Sep 2008to Nov 2010
- 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
- Subjects who aged 18 years or older
- Subjects whose written informed consent was obtained complying with the local regulatory requirements prior to their participation in the trial
- Subjects who have histologically or cytologically confirmed unresectable or metastatic epithelial cancer of the exocrine pancreas. High-quality contrast-enhanced CT scanning is required to evaluate resectability. Measurable disease is not required.
- Subjects with no other malignancy diagnosed within past five years except for:
- Cured non-melanoma skin cancer
- Cured cervical intraepithelial neoplasia (CIN)
- Cured In-situ cervical cancer (CIS)
- Subjects who are ECOG performance status of ≤ 1
Who cannot join
None listed.
About this study
This is a phase I/II trial to determine the maximum tolerated dose and recommended phase II dose of the combination therapy with Genexol-PM and gemcitabine (hereafter Genexol-PM plus gemcitabine) and to evaluate the efficacy and safety of Genexol-PM regimens (monotherapy and combination with gemcitabine) and gemcitabine monotherapy in subjects with locally advanced or metastatic pancreatic cancer.
- Conditions
- Pancreatic Cancer
- Being tested
- Genexol-PM
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genexol-PMDrug
Cremophor EL-free polymeric micelle of paclitaxel
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Genexol-PM 220 mg/m2 + Gemcitabine 1,250 mg/m2 Receives: Drug: Genexol-PM |
| Cohort 2 | Experimental | Genexol-PM 260 mg/m2 + Gemcitabine 1,250 mg/m2 Receives: Drug: Genexol-PM |
| Cohort 3 | Experimental | Genexol-PM 300 mg/m2 + Gemcitabine 1,250 mg/m2 Receives: Drug: Genexol-PM |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximum tolerated dose (MTD) of the combination therapy with Genexol-PM and gemcitabine
Measured: 1 year
The recommended phase II dose of the combination therapy with Genexol-PM and gemcitabine
Measured: 1 year
Secondary outcomes (4)
Objective response rate (complete response (CR) + partial response (PR))
Measured: 1 year
Time to tumor progression
Measured: 1 year
Progression free survival
Measured: 1 year
Safety profiles
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2009 (estimated)
- Study startSep 2008
- Primary completionAug 2009
- Study completionNov 2010
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samyang Biopharmaceuticals Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00882973
- Sponsor's protocol ID
- GPMPC202
- Status last verified
- May 2017
- First submitted
- 16 Apr 2009
- Last updated
- 5 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial to Determine the Maximum Tolerated Dose of Genexol-PM Plus Gemcitabine and Evaluate Efficacy and Safety of Genexol-PM Regimens in Subjects With Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT00882973
- Acronym / sponsor ID
- GPMPC202
- Conditions
- Pancreatic Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Samyang Biopharmaceuticals CorporationIndustry (pharma, biotech, devices)
- Study start
- Sep 2008 (actual)
- Primary completion
- Aug 2009 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 17 Apr 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.
This is a phase I/II trial to determine the maximum tolerated dose and recommended phase II dose of the combination therapy with Genexol-PM and gemcitabine (hereafter Genexol-PM plus gemcitabine) and to evaluate the efficacy and safety of Genexol-PM regimens (monotherapy and combination with gemcitabine) and gemcitabine monotherapy in subjects with locally advanced or metastatic pancreatic cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Genexol-PMGenexol-PM 220 mg/m2 + Gemcitabine 1,250 mg/m2 |
| Cohort 2 | Experimental | Drug: Genexol-PMGenexol-PM 260 mg/m2 + Gemcitabine 1,250 mg/m2 |
| Cohort 3 | Experimental | Drug: Genexol-PMGenexol-PM 300 mg/m2 + Gemcitabine 1,250 mg/m2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects who aged 18 years or older
- Subjects whose written informed consent was obtained complying with the local regulatory requirements prior to their participation in the trial
- Subjects who have histologically or cytologically confirmed unresectable or metastatic epithelial cancer of the exocrine pancreas. High-quality contrast-enhanced CT scanning is required to evaluate resectability. Measurable disease is not required.
- Subjects with no other malignancy diagnosed within past five years except for:
- Subjects who are ECOG performance status of ≤ 1
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Genexol-PMCremophor EL-free polymeric micelle of paclitaxel | Drug | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
The maximum tolerated dose (MTD) of the combination therapy with Genexol-PM and gemcitabine
Time frame: 1 year
The recommended phase II dose of the combination therapy with Genexol-PM and gemcitabine
Time frame: 1 year
4 secondary outcomes
Objective response rate (complete response (CR) + partial response (PR))
Time frame: 1 year
Time to tumor progression
Time frame: 1 year
Progression free survival
Time frame: 1 year
Safety profiles
Time frame: 1 year
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 5 May 2017.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Genexol-PM in people with Pancreatic Cancer, run by Samyang Biopharmaceuticals Corporation.
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 8 inclusion and 0 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 5 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The maximum tolerated dose (MTD) of the combination therapy with Genexol-PM and gemcitabine (time frame: 1 year). 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?
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 5 May 2017.