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COMPLETEDPHASE1/PHASE2

Study of Safety and Efficacy of Glufosfamide in Combination With Gemcitabine in Cancer

A Phase 1/2 Dose-Escalation Study of the Safety, Efficacy and Pharmacokinetics of Glufosfamide in Combination With Gemcitabine in Advanced Solid Tumors and Pancreatic Adenocarcinoma

NCT00102752•Threshold Pharmaceuticals

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine the safety of glufosfamide when administered in combination with gemcitabine.

Detailed Description

This study, TH-CR-301, is a Phase 1/2 study that will evaluate the efficacy and safety of glufosfamide in combination with gemcitabine in advanced solid tumors or in first line treatment of pancreatic cancer. Study Hypothesis: Glufosfamide in combination with gemcitabine may provide benefits in survival to patients with advanced solid tumors or metastatic pancreatic cancer.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•At least 18 years of age
•Histologically or cytologically confirmed, locally advanced or metastatic solid malignancy; previously treated with at least one chemotherapy regimen for advanced or metastatic disease or no effective standard treatment is available OR
•Metastatic and/or locally advanced, inoperable pancreatic adenocarcinoma proven either by histology (surgical biopsy) or cytology (CT- or endoscopic-guided)
•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
•Women of childbearing potential and men to use effective means of contraception from entry into the study through 6 months after the last dose
•Ability to understand the purposes and risks of the study and provide written informed consent.

Exclusion Criteria

•Prior chemotherapy for metastatic/locally advanced pancreatic cancer
•Prior administration of gemcitabine
•Radiation therapy within 28 days prior to study start
•Hormonal therapy, biologic therapy, chemotherapy or other systemic anti-tumor therapy for cancer within 21 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
•History or symptoms of cardiovascular disease (NYHA Class 3 or 4)
•Other primary malignancies (other than treated non-melanoma skin cancer or treated in situ cancer) within the past 5 years
•Major surgery within 3 weeks of the start of study treatment, without complete recovery
+12 more criteria

Locations (9)

Arizona Cancer Center

Tucson, Arizona, United States

Indiana Cancer Center

Indianapolis, Indiana, United States

Norton Healthcare Cancer Center

Louisville, Kentucky, United States

Hospital de Doenças Cardiovasculares - Biocor

Nova Lima, BH, Brazil

Hospital Mãe de Deus

Porto Alegre, Rio Grande do Sul, Brazil

Hospital Nossa Senhora da Conceição

Porto Alegre, Rio Grande do Sul, Brazil

Fundação Pio XII - Hospital de Câncer de Barretos

Barretos, São Paulo, Brazil

Universidade Federal de São Paulo - Hospital São Paulo

São Paulo, São Paulo, Brazil

Hospital Israelita Albert Einstein

São Paulo, São Paulo, Brazil

Key Dates

Start Date

December 1, 2004

Primary Completion Date

July 1, 2007

Completion Date

July 1, 2007

Last Updated

April 30, 2009

Enrollment

Estimated participants

Conditions

NeoplasmsPancreatic Neoplasms

Interventions

Glufosfamide

DRUG

Gemcitabine

DRUG

Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease

NCT00026884

Malignant NeoplasmsHereditary Neoplastic Syndromes+3 more

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RECRUITINGPHASE3

A Two-Part Phase 3 Study of Sofetabart Mipitecan (LY4170156) in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Part B) Ovarian Cancer

NCT07213804

Ovarian NeoplasmsFallopian Tube Neoplasms+2 more

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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 Safety and Efficacy of Glufosfamide in Combination With Gemcitabine in Cancer

Inclusion Criteria

Exclusion Criteria

Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease

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