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

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
Sponsor:
Information provided by:
Protgen Ltd
ClinicalTrials.gov Identifier:
NCT01219192
First received: October 8, 2010
Last updated: October 27, 2010
Last verified: October 2010
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer
Drug: M2ES
Drug: M2ES 60mg
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study of M2ES in Patients With Advanced Pancreatic Cancer After Gemcitabine Treatment Failure

Resource links provided by NLM:


Further study details as provided by Protgen Ltd:

Primary Outcome Measures:
  • MDT [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
    The maximum tolerable dosage


Secondary Outcome Measures:
  • PFS [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    progress free survival


Estimated Enrollment: 24
Study Start Date: August 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: M2ES 15mg Drug: M2ES
M2ES IV D1,8,15,21 every 28 days a cycle
Other Name: M2ES 15mg intervention
Experimental: M2ES 30mg Drug: M2ES
M2ES IV D1,8,15,21, every 28days a cyce.
Other Name: M2ES 30mg intervention
Experimental: M2ES 45mg Drug: M2ES
M2ES 45mg IV D1,8,15,22 28days a cycle
Other Name: M2ES 45mg intervention
Experimental: M2ES 60mg Drug: M2ES 60mg
M2ES 60mg IV D1,8,15,22 every 28days a cycle
Other Name: M2ES 60mg intervention

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01219192

Contacts
Contact: Long CHENG, master 8610629792458 chenglong.bj@gmail.com
Contact: Fei WU, master 8610629792458

Locations
China, Tianjin
Tianjin Medical University Cancer Institute and Hospital Recruiting
Tianjin, Tianjin, China, 300060
Contact: Jihui HAO, MD    862223359929      
Sponsors and Collaborators
Protgen Ltd
Investigators
Principal Investigator: Shunchang JIAO, MD Chinese PLA General Hospital
  More Information

No publications provided

Responsible Party: Guodong CHANG, Protgen Ltd
ClinicalTrials.gov Identifier: NCT01219192     History of Changes
Other Study ID Numbers: M2ES2010-2
Study First Received: October 8, 2010
Last Updated: October 27, 2010
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 25, 2014