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

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.

Study Overview

• Status: Unknown
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Drug: M2ES; Drug: M2ES; Drug: M2ES; Drug: M2ES 60mg

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 Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Long CHENG, master; Phone Number: 8610629792458; Email: chenglong.bj@gmail.com
• Study Contact Backup: Name: Fei WU, master; Phone Number: 8610629792458

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300060
      • Recruiting
      • Tianjin Medical University Cancer Institute and Hospital
      • Contact: Jihui HAO, MD; Phone Number: 862223359929

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: M2ES 15mg	Drug: M2ES; M2ES IV D1,8,15,21 every 28 days a cycle; Other Names: M2ES 15mg intervention; Drug: M2ES; M2ES IV D1,8,15,21, every 28days a cyce.; Other Names: M2ES 30mg intervention; Drug: M2ES; M2ES 45mg IV D1,8,15,22 28days a cycle; Other Names: M2ES 45mg intervention
Experimental: M2ES 30mg	Drug: M2ES; M2ES IV D1,8,15,21 every 28 days a cycle; Other Names: M2ES 15mg intervention; Drug: M2ES; M2ES IV D1,8,15,21, every 28days a cyce.; Other Names: M2ES 30mg intervention; Drug: M2ES; M2ES 45mg IV D1,8,15,22 28days a cycle; Other Names: M2ES 45mg intervention
Experimental: M2ES 45mg	Drug: M2ES; M2ES IV D1,8,15,21 every 28 days a cycle; Other Names: M2ES 15mg intervention; Drug: M2ES; M2ES IV D1,8,15,21, every 28days a cyce.; Other Names: M2ES 30mg intervention; Drug: M2ES; M2ES 45mg IV D1,8,15,22 28days a cycle; Other Names: M2ES 45mg intervention
Experimental: M2ES 60mg	Drug: M2ES 60mg; M2ES 60mg IV D1,8,15,22 every 28days a cycle; Other Names: M2ES 60mg intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MDT	The maximum tolerable dosage	3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	progress free survival	4 months

Collaborators and Investigators

• Sponsor: Protgen Ltd
• Investigators: Principal Investigator: Shunchang Jiao, MD, Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Anticipated): December 1, 2011
• Study Completion (Anticipated): December 1, 2011

Study Registration Dates

• First Submitted: October 8, 2010
• First Submitted That Met QC Criteria: October 8, 2010
• First Posted (Estimate): October 13, 2010

Study Record Updates

• Last Update Posted (Estimate): October 28, 2010
• Last Update Submitted That Met QC Criteria: October 27, 2010
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: M2ES2010-2