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

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00102752
• Other study ID #: TH-CR-301
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 1, 2005
• Last updated: April 28, 2009
• Start date: December 2004
• Est. completion date: July 2007

Study information

• Verified date: April 2009
• Source: Threshold Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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 cancer.

Study Hypothesis: Glufosfamide in combination with gemcitabine may provide benefits in survival to patients with advanced solid tumors or metastatic pancreatic cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Neoplasms
• Pancreatic Neoplasms

Intervention

Drug:
• Glufosfamide

• Gemcitabine

Locations

Country	Name	City	State
Brazil	Fundação Pio XII - Hospital de Câncer de Barretos	Barretos	SP
Brazil	Hospital de Doenças Cardiovasculares - Biocor	Nova Lima	BH
Brazil	Hospital Mãe de Deus	Porto Alegre	RS
Brazil	Hospital Nossa Senhora da Conceição	Porto Alegre	RS
Brazil	Hospital Israelita Albert Einstein	São Paulo	SP
Brazil	Universidade Federal de São Paulo - Hospital São Paulo	São Paulo	SP
United States	Indiana Cancer Center	Indianapolis	Indiana
United States	Norton Healthcare Cancer Center	Louisville	Kentucky
United States	Arizona Cancer Center	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Threshold Pharmaceuticals	PPD

Countries where clinical trial is conducted

United States,  Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall objective response rate
Secondary	Overall survival
Secondary	6- and 12- month survival
Secondary	Progression-free survival
Secondary	Duration of objective response
Secondary	Serum CA-19-9

External Links

•   Threshold Pharmaceuticals Website