E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The cachexia associated with terminal gastrointestinal adenocarcinomas |
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MedDRA Classification |
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 |
The assess the ability of Thalidomide to attenuate or reverse the weight loss and weakness experienced by those with incurable gastrointestinal adenocarcinomas |
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E.2.2 | Secondary objectives of the trial |
To assess the ability of Thalidomide to extend the survival times of those with terminal gastrointestinal adenocarcinomas. The assess the effect on circulating levels of cytokines and tumour factors previously implicated in the development of cachexia. To assess the safety and tolerability in of Thalidomide in this patient group. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
·Have a histological or cytological diagnoisis of upper gastrointestinal adenocarcinoma. ·Have no curative options available that are acceptable to the patient ·Have a predicted survival of at least 4 weeks. ·Aged over 18 years at the time to entry into the trial. ·Able to understand the information given and to give written informed consent. ·Able to take oral medications. ·Agree to the conditions of use of Thalidomide as enumerated (see appendix) ·Women under the age of 54, and those over 54 but still menstruating, must have a negative urinary pregnancy test and negative pregnancy tests repeated on a monthly basis until one month after completion of the trial |
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E.4 | Principal exclusion criteria |
·Unable to provide informed consent ·Involved in any other trial during the study period ·Pregnant or breast feeding ·Unable or considered unlikely to avoid pregnancy ·Evidence of peripheral neuropathy, severe constipation, vertigo or vestibular disease ·Unable to take oral medication ·Previous adverse reaction to Thalidomide ·Any condition which is judged by the investigator to make the patient unsuitable for inclusion into the study such as severe concurrent hepatic, renal, haematological, gastrointestinal, endocrine, neurological, pulmonary, or cardiac disease ·Abnormal haematological or biochemical blood results at screening considered by the investigator to make the patient unsuitable for inclusion into the study.
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E.5 End points |
E.5.1 | Primary end point(s) |
Rate of clinical response as defined by attenuation of weight loss or improvement in quality of life. |
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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 | Information not present in EudraCT |
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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
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 | 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 | 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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The last phone call to the last subject undergoing the trial (all subjects will receive a phone call one month after their last visit) |
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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 | 0 |
E.8.9.1 | In the Member State concerned days | |