E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Advanced pancreatic adenocarcinomas who escaped to a first ligne chemotherapy treatment based on Gemcitabine. |
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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 | 10033613 |
E.1.2 | Term | Pancreatic carcinoma recurrent |
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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 |
Evaluation of the efficacy of efavirenz as second-line monotherapy for the treatment of advanced pancreatic adeno-carcinomas in terms of non-morphological progression at 2 months. |
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E.2.2 | Secondary objectives of the trial |
· Evaluation of non-morphological progression at 4 months, · Evaluation of non biological progression at 2 and 4 months, · Evaluation of the quality of life at 2 and 4 months, · Evaluation of the overall, progression-free, and event-free survivals, · Evaluation of the tolerability and safety profile of efavirenz |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
LINE 1 methylation level measurement. Efavirenz blood level measurement. |
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E.3 | Principal inclusion criteria |
1. Provision of written informed consent prior any study-related procedures. 2. Male/Female aged 18 years and over. 3. Previously confirmed histological diagnosis of pancreas adenocarcinoma. 4. Evidence of metastases radiologically documented, in non-irradiated zone. Disease measured according to RECIST criteria. 5. Escape to a first line chemotherapy treatment based on Gemcitabine. 6. Adjuvant chemotherapy (one line only) and/or radiotherapy authorized. 7. Word Health Organisation (WHO) performance status ranged from 0 to 2 or Karnofsky > 60%. 8. Haematological function: polynuclear neutrophiles (PNN) >= 1,5 G/L, platelets (PL) >= 100 G/L, haemoglobin >= 10 g/dL. 9. Renal function: plasmatic creatinine <= 1,25 x LSN. 10. Hepatic function: alkaline phosphatises < 5N, bilirubine < 3N. 11. Negative pregnancy test (betaHCG) and contraception for women in age to procreate. 12. Clinical and biological examination within the 7 days before inclusion and start treatment. 13. Radiological TDM and/or IRM test within the 30 days before inclusion. 14. Compliance of the subjects with treatment rules and study follow-up. 15. Patients with French Social Security in compliance with the French law relating to biomedical research (Huriet Law 88-1138 and related decrees). |
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E.4 | Principal exclusion criteria |
1. Histological types of pancreatic cancer other than adenocarcinomas. 2. Disease not measurable or not measured at the inclusion. 3. Presence of metastases in the central nervous system. 4. Previous other cancer, except: · If previous cancer is older than 5 years and considered in complete remission, · In situ cervical cancer, · Basocellular cutaneous carcimomas. 5. Subjects receiving second line treatment or more. 6. Known hypersensitivity to study treatment and to their excipients. 7. Severe renal failure. 8. Severe hepatic impairment. 9. Yellow fever vaccine. 10. Concomitant treatment with terfenadine, astemizole, cisapride, midazolam, triazolam, pimozide, bepridil, rye alkaloids, voriconazole, herbal extract from St. John's wort (Hypericum perforatum). 11. Depressive status (with a score ≥ 19 on the HAD scale). 12. Pregnancy or lactation. 13. Any unresolved toxicity greater than CTC grade 1 from previous anticancer therapy. 14. Currently active diarrhoea that may affect the ability of the patient to absorb the study treatment. 15. Previous exposure or any previous treatment acting on signal transduction pathway. 16. Participation in a clinical study and / or receipt of an investigational drug during the last 30 days. 17. Previous enrolment in the present study. 18. Patient unable to follow and comply with the study procedures because of any geographical, psychiatric, social or psychological reasons. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary variable is non-morphological progression as defined by the RECIST criteria (complete response, partial response or stable disease). |
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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 | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
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 | No |
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) | 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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
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 | Yes |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 6 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |