E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Pancreatic ductal adenocarcinoma, non resectable |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10033600 |
E.1.2 | Term | Pancreatic adenocarcinoma non-resectable |
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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 |
To investigate the feasibility and safety of combined Sulfasalazine/Gemcitabine treatment.
The primary parameter is: Number of treatment days defined as the number of days from the first dose of Sulfasalazine to the last dose of either Sulfasalzine or Gemcitabine. |
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E.2.2 | Secondary objectives of the trial |
To investigate the efficacy of combined Sulfasalazine / Gemcitabine treatment.
The secondary parameters are:
Complete remission time, defined as the number of days from the documented start of complete remission to observed progression of disease.
Survival time, defined as number of days from the first dose of Gemcitabine to date of death.
Progressionfree time, definined as the number of days from the first dose of Gemcitabine to documented progression of disease |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Male or female adult patient, age >18 years Women of childbearing potential must have a negative pregnancy test prior to enrollment and be willing to use appropiate contraception during the entire trial Histologically diagnosed advanced non resectable pancreatic ductal adenocarcinoma Presence of a two-dimensional measurable tumor lesion Expected survival time > 12 weeks Haemoglobin ≥ 9 g/dl White Blood Cell Count > 3500/µl Platelet count > 100.000/µl Total number of granulocytes > 1000/µl Bilirubin < 2 mg/dl Creatinin < 1,5 xULN ECOG performance status ≤ 2 Written informed consent |
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E.4 | Principal exclusion criteria |
Other malignant diseases Chemo- or radiotherapy prior to enrollment History of hypersensitivity to sulfonamides, salicylates or gemcitabine or any of the addivites used in the study drugs Immunsuppressed or HIV-seropositive patients Clinically important infection Psychiatric disease Porphyria Impaires hepatic or renal function Hepatitis History of alcohol or drug abuse Ileus Erythema exsudativum multiforme Glucose-6-phosphate-dehydrogenase-deficiency Bronchial asthma Concomitant treatment with ampicilline, neomycine, rifampicin, ethambutol, hexamethylentetramin, cholestyramine, colestipol, methotrexate, sulfonylurea, iron , phenylbutazone or Sulfinpyrazone Inability of taking part in planned study visits Pregnant or nursing women Participation in other clinical trials during the last 4 weeks prior to enrollment
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E.5 End points |
E.5.1 | Primary end point(s) |
Number of treatment days defined as the number of days from the first dose of Sulfasalazine to the last dose of either Sulfasalzine or Gemcitabine.
Patients will be discontinued from the trial for safety, feasibility and/or ethical reasons.
Feasibility and safety reasons are:
Progression of tumor Inaceptable toxic reaction (CTCAE Grade 4)
Safety and ethical reasons are :
Withdrawal of informed consent More beneficial treatment available, desicion taken by responsible physician Presence of exclusion criteria
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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 | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
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 | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
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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End of trial is the last visit of the last subject undergoing the trial. |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |