NCT01218880

Brief Summary

Phase I trail will be conducted to evaluate the safety of M2ES in combination with gemcitabine in locally advanced or metastatic pancreatic cancer.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
21

participants targeted

Target at P25-P50 for phase_1 pancreatic-cancer

Timeline
Completed

Started Jun 2010

Shorter than P25 for phase_1 pancreatic-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 11, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

October 19, 2010

Status Verified

September 1, 2010

Enrollment Period

1.1 years

First QC Date

October 8, 2010

Last Update Submit

October 18, 2010

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

  • Maximum tolerant dose

    8 week

Secondary Outcomes (1)

  • objective response rate

    8 weeks

Study Arms (4)

M2ES-A

EXPERIMENTAL
Drug: M2ES 7.5mg

M2ES-B

EXPERIMENTAL
Drug: M2ES 15mg

M2ES-C

EXPERIMENTAL
Drug: M2ES 30mg

M2ES-D

EXPERIMENTAL
Drug: M2ES 45mg

Interventions

M2ES 7.5mgDRUG

M2ES Dosage：7.5mg/m2

Also known as: M2ES
M2ES-A
M2ES 15mgDRUG

M2ES Dosage：15mg/m2

Also known as: M2ES
M2ES-B
M2ES 30mgDRUG

M2ES Dosage：30mg/m2

Also known as: M2ES
M2ES-C
M2ES 45mgDRUG

M2ES Dosage：45mg/m2

Also known as: M2ES
M2ES-D

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • patients had histologically or cytologically confirmed pancreatic adenocarcinoma that was not amenable to potentially curative surgery.
  • No prior chemotherapy was allowed.
  • Prior radiation therapy was allowed provided that the only sites of measurable disease were not located within the radiation port.
  • to 60 years of age
  • Karnofsky performance status (KPS) of 60-100 points
  • Unidimensionally 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 ≥4×109/L, absolute neutrophil count ≥ 1.5×109/L, platelet count ≥100×109/L, hemoglobin ≥ 9g/dL, total bilirubin ≤2 upper limit of normal \[ULN\],AST ≤ 1.5 ULN, or ≤ 3 ULN if there was evidence of liver metastases; alkaline phosphatase ≤ 1.5 ULN, or ≤ 3 ULN if there was evidence of liver Metastases; creatinine clearance ≥50 mL/min.
  • life expectancy of at least 12 weeks.
  • All patients provided written informed consent according to federal and institutional guidelines.

You may not qualify if:

  • patients had clinically apparent CNS disease ( primary brain tumors, tumor related apoplexy, CNS metastases, 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 4 weeks intervals between the last administration of the targeted therapy regimen and study entry.
  • radiation therapy have not been completed 4 weeks before enrollment.
  • major surgery within the prior 4 weeks;
  • participating any clinical trial within the prior 4 weeks;
  • Pregnant or lactating women.
  • tumor involvement of major blood vessels
  • uncontrolled intercurrent illness as following: prior or ongoing uncontrolled hypertension;angina pectoris; congestive cardiac failure; myocardial ischemia, infarction, uncompensated coronary artery disease within the past 6 months; Uncontrolled arrhythmia; Uncontrolled diabetes mellitus; Uncontrolled infection.
  • chronic renal disease.
  • urine protein ≥ 500 mg in 24 hours;
  • prior history of gastrointestinal bleeding, hemoptysis, bleeding diathesis.
  • pulmonary embolus, or deep venous thrombosis
  • ECG: QTC ≥ 480 ms
  • Patients on therapeutic doses of heparin or antiplatelet agents.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Zhaosheng Li, MD

    Shanghai Changhai Hosptial

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhaosheng Li, MD

CONTACT

8621-81873241zhsli@81890.net

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 11, 2010

Study Start

June 1, 2010

Primary Completion

July 1, 2011

Study Completion

December 1, 2011

Last Updated

October 19, 2010

Record last verified: 2010-09

Locations

CN(1)