A Randomized Phase 3 Study of the Efficacy and Safety of Glufosfamide Compared with Best Supportive Care in Metastatic Pancreatic Adenocarcinoma Previously Treated with Gemcitabine

• Register: EUCTR
• Last refreshed on: 7 October 2014
• Main ID: EUCTR2004-001363-22-CZ
• Date of registration: 18/08/2004
• Prospective Registration: Yes
• Primary sponsor: Threshold Pharmaceuticals
• Public title: A Randomized Phase 3 Study of the Efficacy and Safety of Glufosfamide Compared with Best Supportive Care in Metastatic Pancreatic Adenocarcinoma Previously Treated with Gemcitabine
• Scientific title: A Randomized Phase 3 Study of the Efficacy and Safety of Glufosfamide Compared with Best Supportive Care in Metastatic Pancreatic Adenocarcinoma Previously Treated with Gemcitabine
• Date of first enrolment: 10/12/2004
• Target sample size: 306
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-001363-22
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Best Supportive Care

Countries of recruitment

Czech Republic

Key inclusion & exclusion criteria

Inclusion criteria:
? At least 18 years of age
? Pancreatic adenocarcinoma proven either by histology (surgical biopsy) or cytology (CT- or endoscopic-guided)
? Metastatic pancreatic cancer
? Disease progression during or after treatment with gemcitabine (alone or in combination with other agents; at regular, not radiosensitizing, doses) for advanced/metastatic pancreatic cancer
? 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
? All women of childbearing potential and all men must agree to use effective means of contraception (surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) from entry into the study through 3 months after the last dose
? Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator’s IRB/Ethics Committee

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
? More than one prior systemic therapy regimen for metastatic/locally advanced pancreatic cancer
? Hormonal therapy, radiation therapy, biologic therapy, chemotherapy or other systemic antitumor therapy for pancreatic cancer within 14 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 2, 3, or 4), particularly coronary artery disease, arrhythmias or conduction defects with risk of cardiovascular instability, uncontrolled hypertension, clinically significant pericardial effusion, or congestive heart failure
? No other active malignancies (other than treated non-melanoma skin cancer or treated in situ cancer) within the past year
? 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)
o Hemoglobin <9 g/dL (may receive transfusion or erythropoietin to maintain)
o ANC <1500/µL
o Platelet count <100,000/µL
o Total bilirubin > ULN
o AST/ALT > 2.5-fold above ULN (>5-fold above ULN if liver metastases)
o Serum creatinine > 2 mg/dL
o Creatinine clearance < 60 mL/min (calculated by Cockcroft-Gault formula)
? 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, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study.
? Unwillingness or inability to comply with the study protocol for any other reason



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Previously treated metastatic pancreatic adenocarcinoma
MedDRA version: 7.0 Level: LLT Classification code 10033599

Intervention(s)

Product Name: glufosfamide
Product Code: D-19575
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: glufosfamide
CAS Number: 132682-98-5
Current Sponsor code: D-19575
Other descriptive name: Beta-D-Glucopyranosyl-N,N´-di-(2-chloroethyl)-phosphoric acid diamide
Concentration unit: g gram(s)
Concentration type: equal

Primary Outcome(s)

Primary end point(s): Overall survival and safety.

Main Objective: 1) To evaluate the efficacy of glufosfamide in subjects with metastatic pancreatic adenocarcinoma previously treated with gemcitabine as measured by overall survival compared with best supportive care
2) To evaluate the safety of glufosfamide in subjects with metastatic pancreatic adenocarcinoma previously treated with gemcitabine

Secondary Objective: 1) To evaluate the efficacy of glufosfamide in subjects with metastatic pancreatic adenocarcinoma previously treated with gemcitabine as measured by objective response rate, duration of response, progression-free survival, 6-and 12-month survival, changes in performance status, changes in VAS pain score and CA 19-9 response compared with best supportive care
2) To evaluate clinical benefit response in a subset of subjects

Secondary ID(s)

TH-CR-302