E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Capecitabine in combination with chemotherapy in patients with advanced and/or metastatic gastric cancer suitable to be treated with a fluoropirimidine based regimen to assess the safety profile specifically the incidence of Hand –Foot Syndrom. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10017758 |
E.1.2 | Term | Gastric cancer |
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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 assess the safety profile of capecitabine when combined with chemotherapy as first-line treatment of advanced and/or metastatic gastric cancer, specifically the incidence of Hand –Foot Syndrom. |
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E.2.2 | Secondary objectives of the trial |
To assess the efficacy profile (overall response rate, survival time, duration of response, time to response). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Signed inform consent prior to any study specific procedure. 2. Advanced or metastatic gastric Adenocarcinoma histológically confirmed. 3. Age> 18. 4. Creatinina clearance > 60 mi/min, measured at baseline based on Cockroff – Gault formula (In case that the creatinitn clearance calculated by the formula is < 60 ml/min, it should be calculated again by collecting 24 hours urine. If the value is > 60 ml/min, the patient is elegible). 5. ECOG <2 6. Life expectancy of at least 3 months. 7. Be willing an able to comply with protocol requerimient. 8. Patients with measurable and non-measurable disease could be included.
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E.4 | Principal exclusion criteria |
1. Pregnancy or lactatig woman. Woman with reproductive potential unless using an effective method of contraception (Postmenopausic woman must have been amenorreic during at least 12 months). 2. Previous chemotherapy (except if administered as adjuvant or neoadyuvant treatment and was finalized at least 6 months prior recruitment) 3. Organ transplant (liver and kidney) 4. Cardiac disease clinically significant (for example, congestive heart failure, clinically significant valvular heart disease, high risk uncontrollable arrithmias) or myocardial infarction during the last 12 months. 5. Evidence of metastasis in the central nervous system (CNS). 6. History of any other neoplasia during the last 5 years at exception of cellular basal carcinoma of skin already cured and in-situ carcinoma of the cérvix uterus already cured. 7. Laboratory values:: • neutrófils < 1.5 x 109 /L, platelets < 100 x 109 /L • serum bilirrubina > 1.5 x upper normal limit. • ALT, AST > 2.5 x upper normal limit o > 5 x upper normal limit in case of hepatic metastasis. • Alkaline Phosphatase > 2.5 upper normal limit o 5 x upper normal limit in case of hepatic metastasis o > 10 x upper normal limit in case of bone disease) 8. Major surgery within 4 weeks of start of study treatment, without complete recovery. 9. Receive any investigational drug treatment within 4 weeks of start of study treatment. 10. Intercurrent infections uncontrolled. 11. Patients with serious malabsortion syndrome.
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E.5 End points |
E.5.1 | Primary end point(s) |
To assess the incidence of Hand Foot Syndrom of capecitabine when combined with chemotherapy as first-line treatment of advanced and/or metastatic gastric cancer |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
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 | 51 |
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 recruitment period is expected to be 9 - 10 months. All patients will be offered at least 6 weeks of treatment. Duration will depend on response and tolerance. Patients who are responding or in stable disease, and are tolerating treatment, will be treated until disease progression. Patients who are responding or in stable disease will continue to be followed until disease progression. |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |