TolerabilityPhase 1NCT01260025
Tolerability and Pharmacokinetics of M2ES in the Treatment of Advanced Solid Tumor
A Phase 1 study testing PEDylated Recombinant Human Endostatin in people with Tolerability and Pharmacokinetics, run by Sun Yat-sen University at 1 site in China.
Trial summary
1. MTD and DLT of M2ES 2. Pharmacokinetics of M2ES Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tolerability, Pharmacokinetics, Endostatin
- What is being tested?
- PEDylated Recombinant Human Endostatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Sep 2009to Jan 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years;Genders eligible for study: both;
- Histologic diagnosis of solid malignancies ;
- Performance status of 0 or 1;
- Tumor not amenable to standard curative or palliative therapy;
- life expectancy beyond 3 months;
- Ability to give signed informed consent
Who cannot join
- Pregnancy or lactation;
- Had a history of brain metastasis or a primary brain tumor;
- An active, potentially severe autoimmune disease;
- Serum creatinine ≥1.5mg/dl or a calculated creatinine clearance <60ml/min; WBC count < 2.0×109/L，hemoglobin < 90g/L，and platelet count < 100×109/L; Total bilirubin value < 2.0 times the upper limit of normal (ULN), ALT level < 2.0 times ULN, AST < 2.0 times ULN;
- Positive of anti-HIV antibodies;
- An active infection;
Show all 9Show fewer
- had received chemotherapy or immunotherapy within the prior 4 weeks before study entry
- Participation in a clinical study during the last 28 days
- QTc with Bazett's correction unmeasurable or ≥ 480 msec on screening ECG
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dose Escalation Study of Tolerability and Pharmacokinetics of PEDylated Recombinant Human Endostatin(M2ES)in the Treatment of Advanced Solid Tumor
- MTD and DLT of M2ES
- Pharmacokinetics of M2ES
Read the detailed description
Patients received infusion of M2ES for 120 minutes weekly（d1,d8,d15）by calculated pump and underwent evaluation of vital signs including blood pressure, pulse, respiratory rate, and temperature before treatment, at intervals during infusion, and hourly for 6 hours after infusion. After infusion, patients underwent serial pharmacokinetic sampling. All patients were seen weekly during the study therapy and follow-up and underwent evaluation with physical examination including ECOG performance status, vital signs, and laboratory evaluation with complete blood count with manual differential, chemistry evaluation, prothrombin time/partial thromboplastin time, and urinalysis.
- Conditions
- Tolerability, Pharmacokinetics, Endostatin
- Being tested
- PEDylated Recombinant Human Endostatin
- Keywords
- Tolerability, Pharmacokinetics, Endostatin, antiangiogenesis, cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEDylated Recombinant Human EndostatinDrug
Also called M2ES
The initial dose of PEDylated Recombinant Human Endostatin (M2ES) will be 7.5mg/m2.Dose Escalation to a next higher level will occur when 3 patients in the same dose level complete 28 days of continuous treatment without experiencing a dose-limiting toxicity.
| Study group | Role | What they receive |
|---|---|---|
| PEDylated Recombinant Human Endostatin | Experimental | PEDylated Recombinant Human Endostatin Receives: Drug: PEDylated Recombinant Human Endostatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maxinum tolerated dose of M2ES
To assess the adverse events
Measured: one month
Secondary outcomes (3)
Tumor response rate
To assess the tumor response rate of M2ES in patients with solid, malignant tumours
Measured: one month
Pharmacokinetic effect
Pharmacokinetic effect of M2ES in patients with solid, malignant tumours
Measured: one month
DLT of M2ES
To assess the adverse events
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2010 (estimated)
- Study startSep 2009
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TolerabilityStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Zhang, Sun Yat-sen University
- Investigators
- Li Zhang, Professor, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01260025
- Sponsor's protocol ID
- 2009L01132
- Status last verified
- Feb 2012
- First submitted
- 8 Sep 2010
- Last updated
- 16 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Escalation Study of Tolerability and Pharmacokinetics of PEDylated Recombinant Human Endostatin(M2ES)in the Treatment of Advanced Solid Tumor
- ClinicalTrials.gov ID
- NCT01260025
- Acronym / sponsor ID
- 2009L01132
- Conditions
- Tolerability, Pharmacokinetics, Endostatin
- Keywords
- Tolerability, Pharmacokinetics, Endostatin, antiangiogenesis, cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 15 Dec 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.
- MTD and DLT of M2ES
- Pharmacokinetics of M2ES
Detailed description
Patients received infusion of M2ES for 120 minutes weekly（d1,d8,d15）by calculated pump and underwent evaluation of vital signs including blood pressure, pulse, respiratory rate, and temperature before treatment, at intervals during infusion, and hourly for 6 hours after infusion. After infusion, patients underwent serial pharmacokinetic sampling. All patients were seen weekly during the study therapy and follow-up and underwent evaluation with physical examination including ECOG performance status, vital signs, and laboratory evaluation with complete blood count with manual differential, chemistry evaluation, prothrombin time/partial thromboplastin time, and urinalysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PEDylated Recombinant Human Endostatin | Experimental | Drug: PEDylated Recombinant Human EndostatinPEDylated Recombinant Human Endostatin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 18 and 65 years;Genders eligible for study: both;
- Histologic diagnosis of solid malignancies ;
- Performance status of 0 or 1;
- Tumor not amenable to standard curative or palliative therapy;
- life expectancy beyond 3 months;
Key exclusion criteria (9 listed)
- Pregnancy or lactation;
- Had a history of brain metastasis or a primary brain tumor;
- An active, potentially severe autoimmune disease;
- Serum creatinine ≥1.5mg/dl or a calculated creatinine clearance <60ml/min; WBC count < 2.0×109/L，hemoglobin < 90g/L，and platelet count < 100×109/L; Total bilirubin value < 2.0 times the upper limit of normal (ULN), ALT level < 2.0 times ULN, AST < 2.0 times ULN;
- Positive of anti-HIV antibodies;
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 |
|---|---|---|
| PEDylated Recombinant Human EndostatinAlso: M2ESThe initial dose of PEDylated Recombinant Human Endostatin (M2ES) will be 7.5mg/m2.Dose Escalation to a next higher level will occur when 3 patients in the same dose level complete 28 days of continuous treatment without experiencing a dose-limiting toxicity. | Drug | PEDylated Recombinant Human Endostatin |
Primary outcome
Maxinum tolerated dose of M2ES
Time frame: one month
To assess the adverse events
3 secondary outcomes
Tumor response rate
Time frame: one month
Pharmacokinetic effect
Time frame: one month
DLT of M2ES
Time frame: one month
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 16 Feb 2012.
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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 Zhang, Professor principal investigator
Sun Yat-sen University
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 PEDylated Recombinant Human Endostatin in people with Tolerability and Pharmacokinetics, run by Sun Yat-sen University 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 6 inclusion and 9 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 16 Feb 2012. 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?
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?
Maxinum tolerated dose of M2ES (time frame: one month). 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 16 Feb 2012.