Status:
COMPLETED
Study of Safety and Efficacy of Glufosfamide in Combination With Gemcitabine in Cancer
Lead Sponsor:
Threshold Pharmaceuticals
Collaborating Sponsors:
PPD Development, LP
Conditions:
Neoplasms
Pancreatic Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
End Date :
July 1 2007
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00102752
Start Date
December 1 2004
End Date
July 1 2007
Last Update
April 30 2009
Active Locations (9)
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1
Arizona Cancer Center
Tucson, Arizona, United States, 85724
2
Indiana Cancer Center
Indianapolis, Indiana, United States, 46202
3
Norton Healthcare Cancer Center
Louisville, Kentucky, United States, 40202
4
Hospital de Doenças Cardiovasculares - Biocor
Nova Lima, BH, Brazil, 34000-000