Previously treated metastatic pancreatic adenocarcinoma MedDRA version: 7.0 Level: LLT Classification code 10033599
Conditions
Interventions
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 des
Sponsors
Threshold Pharmaceuticals
Eligibility
Sex/Gender
All
Inclusion 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
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 ;Primary end point(s): Overall survival and safety. | — |
Countries
Czech Republic
Outcome results
None listed