Study of M2ES in Patients With Advanced Pancreatic Cancer After Gemcitabine Treatment Failure

Pancreatic Cancer Clinical Trial

Official title:

Phase I Study of M2ES in Patients With Advanced Pancreatic Cancer After Gemcitabine Treatment Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01219192
• Other study ID #: M2ES2010-2
• Status: Recruiting
• Phase: Phase 1
• First received: October 8, 2010
• Last updated: October 27, 2010
• Start date: August 2010
• Est. completion date: December 2011

Study information

• Verified date: October 2010
• Source: Protgen Ltd
• Contact: Long CHENG, master
• Phone: 8610629792458
• Email: chenglong.bj[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. histologically or cytologically confirmed pancreatic adenocarcinoma that was not amenable to potentially curative surgery.

2. All patients must have developed progressive disease (PD) while receiving or within 6 months after discontinuing palliative gemcitabine-based chemotherapy

3. Prior radiation therapy was allowed provided that the only sites of measurable disease were not located within the radiation port.

4. 18 years of age or older

5. Karnofsky performance status (KPS) of 60-100 points

6. measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria

7. 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,

8. life expectancy of at least 12 weeks

Exclusion Criteria:

1. patients had clinically apparent CNS metastases or carcinomatous meningitis

2. 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

3. more than 3 weeks intervals between the last administration of the prior chemotherapy regimen and study entry

4. more than 4 weeks intervals between the last administration of the targeted therapy regimen and study entry

5. major surgery within the prior 6 weeks;

6. Pregnant or lactating women

7. tumor involvement of major blood vessels

8. uncontrolled intercurrent illness

9. A history of myocardial infarction or stroke within the last 6 months, uncontrolled hypertension, unstable angina

10. clinically significant cardiac disease (eg, congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication, or myocardial infarction)

11. urine protein = 500 mg in 24 hours;

12. evidence of bleeding diathesis or coagulopathy

13. Patients on therapeutic doses of low-molecular weight heparin

14. Patients who received thrombolytic agents within the previous month or who required full-dose anticoagulation.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• M2ES
M2ES IV D1,8,15,21 every 28 days a cycle
• M2ES
M2ES IV D1,8,15,21, every 28days a cyce.
• M2ES
M2ES 45mg IV D1,8,15,22 28days a cycle
• M2ES 60mg
M2ES 60mg IV D1,8,15,22 every 28days a cycle

Locations

Country	Name	City	State
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Protgen Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MDT	The maximum tolerable dosage	3 weeks	Yes
Secondary	PFS	progress free survival	4 months	No