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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

Phase 1/Phase 2
18 Years
Not Enrolling
Neoplasms, Pancreatic Neoplasms

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Trial Information

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

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.

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

- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall objective response rate


United States: Food and Drug Administration

Study ID:




Start Date:

December 2004

Completion Date:

July 2007

Related Keywords:

  • Neoplasms
  • Pancreatic Neoplasms
  • Pancreas
  • Cancer
  • Metastatic
  • Glufosfamide
  • Advanced
  • Solid
  • Tumor
  • Advanced Solid Tumors
  • Pancreatic Adenocarcinoma
  • Adenocarcinoma
  • Neoplasms
  • Pancreatic Neoplasms



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Norton Healthcare Cancer Center Louisville, Kentucky  40202-5070
Indiana Cancer Center Indianapolis, Indiana  46202