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

Completed · Phase 1/Phase 2

Conditions studied: Neoplasms, Pancreatic Neoplasms

In brief

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

Key facts

Study ID

NCT00102752

Run by

Threshold Pharmaceuticals

People needed

47

Starts

2004-12-01

Expected to finish

2007-07-01

Last updated by the study team

2009-04-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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
• 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),
• ANC <1500/μL,
• Platelet count <100,000/μL,
• Total bilirubin > 1.5 ×ULN,
• AST/ALT > 2.5-fold above ULN (>5-fold above ULN if liver metastases),
• Serum creatinine > 2 mg/dL,
• Creatinine clearance < 60 mL/min (calculated)
• Females who are pregnant or breast-feeding
• Participation in an investigational drug or device study within 28 days of the first day of dosing on this study
• Concomitant disease or condition that could interfere with the conduct of the study
• Unwillingness or inability to comply with the study protocol for any other reason

Where it is running

• 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

Full record on ClinicalTrials.gov

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