E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Previously treated metastatic pancreatic adenocarcinoma |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 7.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10033599 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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
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E.2.2 | Secondary objectives of the trial |
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
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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
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E.4 | Principal 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
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E.5 End points |
E.5.1 | Primary end point(s) |
Overall survival and safety. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Survival follow-up every 3 months until death. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |