Expired Study
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Indianapolis, Indiana 46202


Purpose:

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


Study summary:

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.


Criteria:

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 - 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


NCT ID:

NCT00102752


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Indianapolis, Indiana 46202
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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