Pancreatic CancerPhase 1NCT01218880
Study With M2ES and Gemcitabine for Patients With Advanced Pancreatic Cancer
A Phase 1 study testing M2ES 7.5mg, M2ES 15mg and M2ES 30mg in people with Pancreatic Cancer, run by Beijing Protgen Biotechnology Development Co., Ltd. at 1 site in China.
Trial summary
Phase I trail will be conducted to evaluate the safety of M2ES in combination with gemcitabine in locally advanced or metastatic pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- M2ES 7.5mg, M2ES 15mg and M2ES 30mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteChina
- Study dates
- Jun 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients had histologically or cytologically confirmed pancreatic adenocarcinoma that was not amenable to potentially curative surgery.
- No prior chemotherapy was allowed.
- Prior radiation therapy was allowed provided that the only sites of measurable disease were not located within the radiation port.
- 18 to 60 years of age
- Karnofsky performance status (KPS) of 60-100 points
- Unidimensionally measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
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- Adequate hematologic, renal, and hepatic function was required as deWned by the following: WBC ≥4×109/L, absolute neutrophil count ≥ 1.5×109/L, platelet count ≥100×109/L, hemoglobin ≥ 9g/dL, total bilirubin ≤2 upper limit of normal [ULN],AST ≤ 1.5 ULN, or ≤ 3 ULN if there was evidence of liver metastases; alkaline phosphatase ≤ 1.5 ULN, or ≤ 3 ULN if there was evidence of liver Metastases; creatinine clearance ≥50 mL/min.
- life expectancy of at least 12 weeks.
- All patients provided written informed consent according to federal and institutional guidelines.
Who cannot join
- patients had clinically apparent CNS disease ( primary brain tumors, tumor related apoplexy, CNS metastases, 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 4 weeks intervals between the last administration of the targeted therapy regimen and study entry.
- radiation therapy have not been completed 4 weeks before enrollment.
- major surgery within the prior 4 weeks;
- participating any clinical trial within the prior 4 weeks;
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- Pregnant or lactating women.
- tumor involvement of major blood vessels
- uncontrolled intercurrent illness as following: prior or ongoing uncontrolled hypertension;angina pectoris; congestive cardiac failure; myocardial ischemia, infarction, uncompensated coronary artery disease within the past 6 months; Uncontrolled arrhythmia; Uncontrolled diabetes mellitus; Uncontrolled infection.
- chronic renal disease.
- urine protein ≥ 500 mg in 24 hours;
- prior history of gastrointestinal bleeding, hemoptysis, bleeding diathesis.
- pulmonary embolus, or deep venous thrombosis
- ECG: QTC ≥ 480 ms
- Patients on therapeutic doses of heparin or antiplatelet agents.
- Patients who received thrombolytic agents or who required full-dose anticoagulation
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Changhai Hospital
Shanghai, Shanghai Municipality, 200433
Zhaosheng Li, MD
About this study
Official title: Phase I Study of M2ES Combined Gemcitabine in Patients With Advanced Pancreatic Cancer
Phase I trail will be conducted to evaluate the safety of M2ES in combination with gemcitabine in locally advanced or metastatic pancreatic cancer.
Read the detailed description
Phase I trail will be conducted to determine the MTD and safety of M2ES(administered intravenous infusion on Days 1,8,15,21of a 28-day cycle) in combination with gemcitabine (1000 m/m2). Gemcitabine will be administered as an intravenous infusion on Days 1, 8, and 15 of each 28-day cycle,at the same time determine the safety and efficiency of this combined regime.
- Conditions
- Pancreatic Cancer
- Being tested
- M2ES 7.5mg, M2ES 15mg, M2ES 30mg, M2ES 45mg
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M2ES 7.5mgDrug
Also called M2ES
M2ES Dosage：7.5mg/m2
M2ES 15mgDrug
Also called M2ES
M2ES Dosage：15mg/m2
M2ES 30mgDrug
Also called M2ES
M2ES Dosage：30mg/m2
M2ES 45mgDrug
Also called M2ES
M2ES Dosage：45mg/m2
| Study group | Role | What they receive |
|---|---|---|
| M2ES-A | Experimental | Not described Receives: Drug: M2ES 7.5mg |
| M2ES-B | Experimental | Not described Receives: Drug: M2ES 15mg |
| M2ES-C | Experimental | Not described Receives: Drug: M2ES 30mg |
| M2ES-D | Experimental | Not described Receives: Drug: M2ES 45mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerant dose
Measured: 8 week
Secondary outcomes (1)
objective response rate
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2010 (estimated)
- Study startJun 2010
- Primary completionJul 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
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Protgen Biotechnology Development Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Zhaosheng Li, MD, Principal investigator, Shanghai Changhai Hosptial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01218880
- Sponsor's protocol ID
- M2ES2010-1
- Status last verified
- Sep 2010
- First submitted
- 8 Oct 2010
- Last updated
- 19 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of M2ES Combined Gemcitabine in Patients With Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT01218880
- Acronym / sponsor ID
- M2ES2010-1
- Conditions
- Pancreatic Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Beijing Protgen Biotechnology Development Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Jul 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 11 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.
Phase I trail will be conducted to evaluate the safety of M2ES in combination with gemcitabine in locally advanced or metastatic pancreatic cancer.
Detailed description
Phase I trail will be conducted to determine the MTD and safety of M2ES(administered intravenous infusion on Days 1,8,15,21of a 28-day cycle) in combination with gemcitabine (1000 m/m2). Gemcitabine will be administered as an intravenous infusion on Days 1, 8, and 15 of each 28-day cycle,at the same time determine the safety and efficiency of this combined regime.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| M2ES-A | Experimental | Drug: M2ES 7.5mg |
| M2ES-B | Experimental | Drug: M2ES 15mg |
| M2ES-C | Experimental | Drug: M2ES 30mg |
| M2ES-D | Experimental | Drug: M2ES 45mg |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- patients had histologically or cytologically confirmed pancreatic adenocarcinoma that was not amenable to potentially curative surgery.
- No prior chemotherapy was allowed.
- Prior radiation therapy was allowed provided that the only sites of measurable disease were not located within the radiation port.
- 18 to 60 years of age
- Karnofsky performance status (KPS) of 60-100 points
Key exclusion criteria (16 listed)
- patients had clinically apparent CNS disease ( primary brain tumors, tumor related apoplexy, CNS metastases, 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 4 weeks intervals between the last administration of the targeted therapy regimen and study entry.
- radiation therapy have not been completed 4 weeks before enrollment.
- major surgery within the prior 4 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 |
|---|---|---|
| M2ES 7.5mgAlso: M2ESM2ES Dosage：7.5mg/m2 | Drug | M2ES-A |
| M2ES 15mgAlso: M2ESM2ES Dosage：15mg/m2 | Drug | M2ES-B |
| M2ES 30mgAlso: M2ESM2ES Dosage：30mg/m2 | Drug | M2ES-C |
| M2ES 45mgAlso: M2ESM2ES Dosage：45mg/m2 | Drug | M2ES-D |
Primary outcome
Maximum tolerant dose
Time frame: 8 week
1 secondary outcome
objective response rate
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 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.
Zhaosheng Li, MD principal investigator
Shanghai Changhai Hosptial
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 7.5mg, M2ES 15mg and M2ES 30mg 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 9 inclusion and 16 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 19 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 Zhaosheng Li, MD (8621-81873241, zhsli@81890.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerant dose (time frame: 8 week). 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 19 Oct 2010.