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

NCT01219192 | Unknown Phase 1 DMC

• 1 other identifier: M2ES2010-2
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• MDT

  The maximum tolerable dosage

  3 weeks

Secondary Outcomes (1)

• PFS

  4 months

Study Arms (4)

M2ES 15mg

EXPERIMENTAL

Drug: M2ES

M2ES 30mg

EXPERIMENTAL

Drug: M2ES

M2ES 45mg

EXPERIMENTAL

Drug: M2ES

M2ES 60mg

EXPERIMENTAL

Drug: M2ES 60mg

Interventions

M2ES DRUG

M2ES IV D1,8,15,21 every 28 days a cycle

Also known as: M2ES 15mg intervention

M2ES 15mg

M2ES 60mg DRUG

M2ES 60mg IV D1,8,15,22 every 28days a cycle

Also known as: M2ES 60mg intervention

M2ES 60mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• histologically or cytologically confirmed pancreatic adenocarcinoma that was not amenable to potentially curative surgery.
• All patients must have developed progressive disease (PD) while receiving or within 6 months after discontinuing palliative gemcitabine-based chemotherapy
• Prior radiation therapy was allowed provided that the only sites of measurable disease were not located within the radiation port.
• years of age or older
• Karnofsky performance status (KPS) of 60-100 points
• measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
• 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,
• life expectancy of at least 12 weeks

You may not qualify if:

• patients had clinically apparent CNS metastases or carcinomatous meningitis
• 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
• more than 3 weeks intervals between the last administration of the prior chemotherapy regimen and study entry
• more than 4 weeks intervals between the last administration of the targeted therapy regimen and study entry
• major surgery within the prior 6 weeks;
• Pregnant or lactating women
• tumor involvement of major blood vessels
• uncontrolled intercurrent illness
• A history of myocardial infarction or stroke within the last 6 months, uncontrolled hypertension, unstable angina
• clinically significant cardiac disease (eg, congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication, or myocardial infarction)
• urine protein ≥ 500 mg in 24 hours;
• evidence of bleeding diathesis or coagulopathy
• Patients on therapeutic doses of low-molecular weight heparin
• Patients who received thrombolytic agents within the previous month or who required full-dose anticoagulation.

Sponsors & Collaborators

• Protgen Ltd: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Methods

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Shunchang JIAO, MD

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Long CHENG, master

CONTACT

8610629792458; chenglong.bj@gmail.com

Fei WU, master

CONTACT

8610629792458

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 8, 2010
• First Posted: October 13, 2010
• Study Start: August 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: October 28, 2010

Record last verified: 2010-10

Locations

CN (1)