E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chemo-Therapy Induced Diarrhea |
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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 |
• To determine the effectiveness of Sandostatin® LAR® in secondary prevention and to study the ability of Sandostatin® LAR® to keep the optimal dosing of planned chemotherapy by preventing the incidence of severe and/or life-threatening diarrhea. This is expressed as the fraction of patients who have received at least a second injection of Sandostatin® LAR® and who develop a less than grade II diarrhea after having received a second subsequent full dose chemotherapy to the number of patients who have received a first injection of Sandostatin® LAR® and who develop a less than grade II diarrhea after the administration of a low dose chemotherapy. |
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E.2.2 | Secondary objectives of the trial |
• To determine the incidence of chemotherapy induced diarrhea. • To determine the incidence of screening failures. • To determine the incidence of treatment failures. • To determine the impact of prevention.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Patient should be Sandostatin® or SSA naïve for at least 3 months prior to study entry (in the therapeutic phase). However, Sandostatin® s.c. is allowed after administration of the full dose chemotherapy as rescue medication. Once the first Sandostatin® LAR® is administered in the protocol, Sandostatin®s.c. is no longer needed. • Patient with histologically proven malignancy treated with chemotherapy and experiencing a more than or equal to grade II diarrhea • All chemotherapeutic regimens administered two or three weekly with or without biotherapies are allowed. (Examples of regimens chemotherapy associated with a ≥ 40 % grade II diarrhea are provided in Appendix 1). • Prior chemotherapy is allowed, even with diarrhoea • Older than 18 years • Written informed consent given • Performance status ECOG less or equal than 2
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E.4 | Principal exclusion criteria |
• Patient with infectious diarrhea or severe irritable bowel or inflammatory bowel disease • HIV positive patients • Biotherapies alone • Patient with known allergic reaction or hypersensitivity to Sandostatin® or SSA analogues • Symptomatic cholecystolithiasis • Uncontrolled diabetes • Female patients who are lactating or child bearing potential without adequate contraceptive measures • Patients who were included in another study protocol less than 30 days before entering this protocol |
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E.5 End points |
E.5.1 | Primary end point(s) |
To determine the number of patients who have received a second injection of Sandostatin® LAR® in secondary prevention and who develop a less than grade II diarrhea after returning to full dose chemotherapy. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
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 | Yes |
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 | No |
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) | No |
E.8.2.2 | Placebo | No |
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.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
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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The planned evaluation visit after the second subsequent full dose chemotherapy administration. |
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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 | |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | |