Study Of The Efficacy And Safety Of Glufosfamide Compared With Best Supportive Care In Metastatic Pancreatic Cancer

Study Overview

Study of the Efficacy and Safety of Glufosfamide Compared With Best Supportive Care in Metastatic Pancreatic Cancer

The primary objectives of the study is to evaluate the effectiveness and safety of glufosfamide in subjects with pancreatic cancer who have been previously treated with gemcitabine as measured by overall survival compared with best supportive care.

TH-CR-302 is a randomized Phase 3 study that will evaluate the efficacy and safety of glufosfamide plus best supportive care (BSC) compared to BSC alone for second line treatment of metastatic pancreatic cancer. BSC includes all medical or surgical interventions that a pancreatic cancer patient should receive to palliate the cancer but excludes treatment with systemic therapies intended to kill the cancer cells. Study Hypothesis: Glufosfamide will provide benefits in survival to patients with metastatic pancreatic cancer over best supportive care. Comparison: Glufosfamide versus best supportive care.

Pancreatic Cancer

DRUG: Glufosfamide

TH-CR-302

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2004-12-10	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2009-04-28
First Submitted that Met QC Criteria 2004-12-09	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2009-04-30
First Posted (ESTIMATED) 2004-12-10	Results First Posted N/A	Last Verified 2009-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Primary Outcome Measures	Measure Description	Time Frame
Overall Survival

Secondary Outcome Measures	Measure Description	Time Frame
Objective tumor response rate
Duration of objective tumor response rate
Progression-free survival
6 month and 12 month survival
Serum CA 19-9
Pain Intensity
Performance Status

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

At least 18 years of age
Pancreatic adenocarcinoma proven either by histology (surgical biopsy) or cytology (CT- or endoscopic-guided)
Metastatic pancreatic cancer
Disease progression during or after treatment with gemcitabine (alone or in combination with other agents; at regular, not radiosensitizing, doses) for advanced/metastatic pancreatic cancer
Measurable or nonmeasurable disease by RECIST criteria (at least one target or nontarget lesion)
Recovered from reversible toxicities of prior therapy
Karnofsky performance status ≥70
All women of childbearing potential and all men must agree to use effective means of contraception (surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) from entry into the study through 6 months after the last dose
Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB/Ethics Committee

More than one prior systemic therapy regimen for metastatic/locally advanced pancreatic cancer (radiosensitizing doses of 5FU or gemcitabine at the time of initial radiotherapy do not count as a prior systemic therapy regimen)
Hormonal therapy, radiation therapy, biologic therapy, chemotherapy or other systemic antitumor therapy for pancreatic cancer within 14 days prior to study start
Symptomatic brain metastases (baseline CT scan is not required in asymptomatic subjects)
Active clinically significant infection requiring antibiotics
Known HIV positive or active hepatitis B or C
Recent (one year) history or symptoms of cardiovascular disease (NYHA Class 2, 3, or 4), particularly coronary artery disease, arrhythmias or conduction defects with risk of cardiovascular instability, uncontrolled hypertension, clinically significant pericardial effusion, or congestive heart failure
No other active malignancies (other than treated non-melanoma skin cancer or treated in situ cancer) within the past year
Major surgery within 3 weeks of the start of study treatment, without complete recovery
Clinically significant abnormalities in laboratory test results (including complete blood count, chemistry panel including electrolytes, and urinalysis) (Hemoglobin <9 g/dL (may receive transfusion or erythropoietin to maintain))

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

PPD Development, LP

Investigators

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record