Study of Safety and Efficacy of Glufosfamide in Combination With Gemcitabine in Cancer
NCT ID: NCT00102752
Last Updated: 2009-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
47 participants
INTERVENTIONAL
2004-12-31
2007-07-31
Brief Summary
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Detailed Description
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Study Hypothesis: Glufosfamide in combination with gemcitabine may provide benefits in survival to patients with advanced solid tumors or metastatic pancreatic cancer.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Glufosfamide
Gemcitabine
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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PPD Development, LP
INDUSTRY
Threshold Pharmaceuticals
INDUSTRY
Locations
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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
Countries
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Related Links
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Threshold Pharmaceuticals Website
Other Identifiers
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TH-CR-301
Identifier Type: -
Identifier Source: org_study_id