Pancreatic CancerPhase 1NCT01219192
Study of M2ES in Patients With Advanced Pancreatic Cancer After Gemcitabine Treatment Failure
A Phase 1 study testing M2ES and M2ES 60mg in people with Pancreatic Cancer, run by Beijing Protgen Biotechnology Development Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety and tolerability and determine the recommended dosing for the treatment in patients with advanced pancreatic cancer after fist-line Gemcitabine treatment failure. 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?
- M2ES and M2ES 60mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- Aug 2010to Dec 2011
- 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
- histologically or cytologically confirmed pancreatic adenocarcinoma that was not amenable to potentially curative surgery.
- All patients must have developed progressive disease (PD) while receiving or within 6 months after discontinuing palliative gemcitabine-based chemotherapy
- Prior radiation therapy was allowed provided that the only sites of measurable disease were not located within the radiation port.
- 18 years of age or older
- Karnofsky performance status (KPS) of 60-100 points
- measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
- Adequate hematologic, renal, and hepatic function was required as deWned by the following: WBC ≥3.5×109/L, absolute neutrophil count ≥ 1.5 × 109/L, platelet count ≥100 × 109/L, hemoglobin≥9g/dL, total bilirubin ≤2.5 upper limit of normal [ULN],AST≤2.5 ULN, or≤5 ULN if there was evidence of liver metastases;alkaline phosphatase≤ 2.5 ULN, or≤ 5 ULN if there was evidence of liver Metastases creatinine clearance≤50 mL/min,
- life expectancy of at least 12 weeks
Who cannot join
- patients had clinically apparent CNS metastases or carcinomatous meningitis
- another active malignancy, or any history of other malignancy within the past 5 years except for nonmelanoma skin cancer and carcinoma in situ of the cervix
- more than 3 weeks intervals between the last administration of the prior chemotherapy regimen and study entry
- more than 4 weeks intervals between the last administration of the targeted therapy regimen and study entry
- major surgery within the prior 6 weeks;
- Pregnant or lactating women
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- tumor involvement of major blood vessels
- uncontrolled intercurrent illness
- A history of myocardial infarction or stroke within the last 6 months, uncontrolled hypertension, unstable angina
- clinically significant cardiac disease (eg, congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication, or myocardial infarction)
- urine protein ≥ 500 mg in 24 hours;
- evidence of bleeding diathesis or coagulopathy
- Patients on therapeutic doses of low-molecular weight heparin
- Patients who received thrombolytic agents within the previous month or who required full-dose anticoagulation.
Trial locations and contacts
1 site in 1 country.
Fei WU, master contact
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Jihui HAO, MD, 862223359929
About this study
Official title: Phase I Study of M2ES in Patients With Advanced Pancreatic Cancer After Gemcitabine Treatment Failure
The purpose of this study is to evaluate the safety and tolerability and determine the recommended dosing for the treatment in patients with advanced pancreatic cancer after fist-line Gemcitabine treatment failure.
Read the detailed description
To evaluate the safety and tolerability and determine the recommended dosing for the treatment in patients with advanced pancreatic cancer after fist-line Gemcitabine treatment failure.We star with the dose M2ES 15mg,then escalate to 30mg 45mg 60mg,to find the recommended dose in clinic practise.
- Conditions
- Pancreatic Cancer
- Being tested
- M2ES, M2ES 60mg
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M2ESDrug
Also called M2ES 15mg intervention
M2ES IV D1,8,15,21 every 28 days a cycle
M2ESDrug
Also called M2ES 30mg intervention
M2ES IV D1,8,15,21, every 28days a cyce.
M2ESDrug
Also called M2ES 45mg intervention
M2ES 45mg IV D1,8,15,22 28days a cycle
M2ES 60mgDrug
Also called M2ES 60mg intervention
M2ES 60mg IV D1,8,15,22 every 28days a cycle
| Study group | Role | What they receive |
|---|---|---|
| M2ES 15mg | Experimental | Not described Receives: Drug: M2ES |
| M2ES 30mg | Experimental | Not described Receives: Drug: M2ES |
| M2ES 45mg | Experimental | Not described Receives: Drug: M2ES |
| M2ES 60mg | Experimental | Not described Receives: Drug: M2ES 60mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
MDT
The maximum tolerable dosage
Measured: 3 weeks
Secondary outcomes (1)
PFS
progress free survival
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2010 (estimated)
- Study startAug 2010
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
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
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Protgen Biotechnology Development Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Shunchang JIAO, MD, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01219192
- Sponsor's protocol ID
- M2ES2010-2
- Status last verified
- Oct 2010
- First submitted
- 8 Oct 2010
- Last updated
- 28 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of M2ES in Patients With Advanced Pancreatic Cancer After Gemcitabine Treatment Failure
- ClinicalTrials.gov ID
- NCT01219192
- Acronym / sponsor ID
- M2ES2010-2
- Conditions
- Pancreatic Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Beijing Protgen Biotechnology Development Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 13 Oct 2010 (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 safety and tolerability and determine the recommended dosing for the treatment in patients with advanced pancreatic cancer after fist-line Gemcitabine treatment failure.
Detailed description
To evaluate the safety and tolerability and determine the recommended dosing for the treatment in patients with advanced pancreatic cancer after fist-line Gemcitabine treatment failure.We star with the dose M2ES 15mg,then escalate to 30mg 45mg 60mg,to find the recommended dose in clinic practise.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| M2ES 15mg | Experimental | Drug: M2ES |
| M2ES 30mg | Experimental | Drug: M2ES |
| M2ES 45mg | Experimental | Drug: M2ES |
| M2ES 60mg | Experimental | Drug: M2ES 60mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- histologically or cytologically confirmed pancreatic adenocarcinoma that was not amenable to potentially curative surgery.
- All patients must have developed progressive disease (PD) while receiving or within 6 months after discontinuing palliative gemcitabine-based chemotherapy
- Prior radiation therapy was allowed provided that the only sites of measurable disease were not located within the radiation port.
- 18 years of age or older
- Karnofsky performance status (KPS) of 60-100 points
Key exclusion criteria (14 listed)
- patients had clinically apparent CNS metastases or carcinomatous meningitis
- another active malignancy, or any history of other malignancy within the past 5 years except for nonmelanoma skin cancer and carcinoma in situ of the cervix
- more than 3 weeks intervals between the last administration of the prior chemotherapy regimen and study entry
- more than 4 weeks intervals between the last administration of the targeted therapy regimen and study entry
- major surgery within the prior 6 weeks;
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 |
|---|---|---|
| M2ESAlso: M2ES 15mg interventionM2ES IV D1,8,15,21 every 28 days a cycle | Drug | M2ES 15mg |
| M2ESAlso: M2ES 30mg interventionM2ES IV D1,8,15,21, every 28days a cyce. | Drug | M2ES 30mg |
| M2ESAlso: M2ES 45mg interventionM2ES 45mg IV D1,8,15,22 28days a cycle | Drug | M2ES 45mg |
| M2ES 60mgAlso: M2ES 60mg interventionM2ES 60mg IV D1,8,15,22 every 28days a cycle | Drug | M2ES 60mg |
Primary outcome
MDT
Time frame: 3 weeks
The maximum tolerable dosage
1 secondary outcome
PFS
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2010.
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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.
Fei WU, master contact
Shunchang JIAO, MD principal investigator
Chinese PLA General Hospital
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 M2ES and M2ES 60mg in people with Pancreatic Cancer, run by Beijing Protgen Biotechnology Development Co., Ltd. at 1 site in China.
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 14 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: status not confirmed, as of the sponsor's last update on 28 Oct 2010. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Long CHENG, master (8610629792458, chenglong.bj@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MDT (time frame: 3 weeks). 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 28 Oct 2010.