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Study of the Efficacy and Safety of Glufosfamide Compared With Best Supportive Care in Metastatic Pancreatic Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

A Randomized Phase 3 Study of the Efficacy and Safety of Glufosfamide Compared With Best Supportive Care in Metastatic Pancreatic Adenocarcinoma Previously Treated With Gemcitabine

NCT00099294•Threshold Pharmaceuticals

View on ClinicalTrials.gov

Summary

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.

Detailed Description

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

Exclusion Criteria

•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))

Locations (111)

Augusta Oncology Associates

Los Angeles, California, United States

Kenmar Research Institute

Los Angeles, California, United States

Mile High Oncology

Denver, Colorado, United States

Northwestern Connecticut Oncology - Hematology Associates

Torrington, Connecticut, United States

Palm Beach Institute of Hematology and Oncology

Boynton Beach, Florida, United States

Hematology/Oncology of the North Shore

Skokie, Illinois, United States

Fort Wayne Medical Oncology/Hem

Fort Wayne, Indiana, United States

Norton Healthcare Center

Louisville, Kentucky, United States

West Michigan Cancer Center

Kalamazoo, Michigan, United States

Hattiesburg Clinic Oncology

Hattiesburg, Mississippi, United States

Key Dates

Start Date

September 1, 2004

Primary Completion Date

January 1, 2007

Completion Date

January 1, 2007

Last Updated

April 30, 2009

Enrollment

300

Estimated participants

Conditions

Pancreatic Cancer

Interventions

Glufosfamide

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 30, 2009Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Testing A New Anti-cancer Drug Combination, Entinostat and ZEN003694, for Advanced and Refractory Solid Tumors

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