Dose Escalation and PK Study of M2ES in Subjects With Advanced Solid Tumors
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Protgen Ltd.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Protgen Ltd
Information provided by:
Protgen Ltd
ClinicalTrials.gov Identifier:
NCT01226030
First received: October 9, 2010
Last updated: October 20, 2010
Last verified: October 2010
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Purpose
This study is dose-escalation open-label study to determine the MTD of M2ES in Subjects With Advanced Solid Tumors the recommended Phase II dose.The recommended dose and regimen of M2ES will be selected to perform the pharmacokinetic study profiles.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Solid Tumors |
Drug: M2ES 7.5mg Drug: M2ES 15mg Drug: M2ES 30mg Drug: M2ES 60mg |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Dose Escalation and PK Study of M2ES in Subjects With Advanced Solid Tumors |
Resource links provided by NLM:
Further study details as provided by Protgen Ltd:
Primary Outcome Measures:
- The maximum tolerate dosage [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]The maxium tolerate dosage
Secondary Outcome Measures:
- Pharmacokinetic (PK) behavior of M2ES in tumor subject [ Time Frame: 4 week ] [ Designated as safety issue: Yes ]Pharmacokinetic (PK) behavior of different doses of M2ES in Subjects With Advanced Solid Tumors
- The incidence rate of adverse event [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]The incidence rate of adverse event
| Estimated Enrollment: | 24 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | June 2011 |
| Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: M2ES 7.5mg
M2ES 7.5mg
|
Drug: M2ES 7.5mg
M2ES 7.5mg
Other Name: M2ES 7.5mg IV D1,8,15,22, every 28days a cycle.
|
|
Experimental: M2ES 15mg
M2ES 15mg
|
Drug: M2ES 15mg
M2ES 15mg
Other Name: M2ES 15mg IV D1,8,15,22, every 28days a cycle.
|
|
Experimental: M2ES 30mg
M2ES 30mg
|
Drug: M2ES 30mg
M2ES 30mg
Other Name: M2ES 30mg IV D1,8,15,22, every 28days a cycle.
|
|
Experimental: M2ES 60mg
M2ES 60mg
|
Drug: M2ES 60mg
M2ES 60mg
Other Name: M2ES 60mg IV D1,8,15,22, every 28days a cycle.
|
Detailed Description:
This study is a Phase I dose-escalation open-label study to determine the MTD of M2ES in Subjects With Advanced Solid Tumors the recommended Phase II dose.The recommended dose and regimen of M2ES will be selected to perform the pharmacokinetic study profiles.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 18 to 60 years of age
- patients had histologically or cytologically confirmed solid tumors that was refractory to standard therapy.
- life expectancy of at least 3 months.
- ECOGPS ≤ 1
- Adequate hematologic, renal, and hepatic function was required as determined by the following: WBC ≥4×109/L, absolute neutrophil count ≥ 1.5×109/L, platelet count ≥100×109/L, hemoglobin ≥ 9g/dL, total bilirubin ≤1.5 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.
Exclusion Criteria:
- Pregnant and latent women, no contraception for women of childbearing age
- Have taken other treatments
- Be allergic to endostatin and other ingredient
- Gastrointestinal Hemorrhage
- Have Participated any clinical trail during the last 4 week
- ECG: QTC ≥ 480 ms
- patients had clinically apparent CNS disease ( primary brain tumors, tumor related apoplexy, CNS metastases, carcinomatous meningitis.)
- Cardiovascular and mental disease
- HIV-1 infected
- HBV, HBV infected ,Hepatitis B surface antigen positive
- Patients on therapeutic doses of heparin or antiplatelet agents.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01226030
Contacts
| Contact: Su LI, PhD | 8620-87343571 | lisusu@126.com |
Locations
| China, Guangdong | |
| Sun Yat-Sen University Cancer Center | Recruiting |
| Guangzhou, Guangdong, China | |
| Contact: Su Li, PhD 8620-87343571 lisusu@126.com | |
| Principal Investigator: LI Zhang, master | |
Sponsors and Collaborators
Protgen Ltd
Investigators
| Principal Investigator: | Li Zhang, master | Sun Yat-sen University |
More Information
No publications provided
| Responsible Party: | Guodong Chang, Protgen Ltd |
| ClinicalTrials.gov Identifier: | NCT01226030 History of Changes |
| Other Study ID Numbers: | PG-2008-2 |
| Study First Received: | October 9, 2010 |
| Last Updated: | October 20, 2010 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Protgen Ltd:
|
Advanced Solid Tumors |
Additional relevant MeSH terms:
|
Neoplasms |
ClinicalTrials.gov processed this record on May 19, 2013