E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
assessment of the effect of CR3294 in preventing oral mucositis induced by conditioning myeloablative regimens in patients undergoing high-dose chemotherapy (HDCT) and autologous HSCT. |
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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 | 10028130 |
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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 | 10017981 |
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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 effect of CR3294 in preventing oral mucositis induced by conditioning myeloablative regimens. |
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E.2.2 | Secondary objectives of the trial |
- To assess the effect of CR3294 in reducing the severity and duration of oral mucositis induced by conditioning myeloablative regimens; - To assess the effect of CR3294 in preventing rate and severity of gut MBI (intestinal mucositis) induced by conditioning myeloablative regimens; - To assess the effect of CR3294 on other outcomes of conditioning myeloablative regimens and the following HSCT; - To assess the safety of CR3294 in patients undergoing conditioning myeloablative regimens and HSCT; - To evaluate the plasma concentration of CR3294 and its metabolite(s) and the urine concentration of CR3294 in this patient population; - To identify mucositis biomarkers correlating with the efficacy of treatment. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Patients with haematological malignancies eligible for conditioning myeloablative high dose chemotherapy that require autologous HSCT; - Age ≥ 18 years; - Conditioning regimens are limited to BEAM or high-dose Melphalan (200 mg/m2) as single agent; - ECOG (Eastern Cooperative Oncology Group) performance status (PS) 0-2; - Eligibility for autologous HSCT according to institutional requirements; - Baseline creatinine level < 2 mg/dl or creatinine clearance > 50 ml/min (calculated); total serum bilirubin < 2 mg/dl; AST, ALT and AP < 2x Upper Limit of Normal-ULN (except patients with active viral hepatitis B or C); - Female patients of child-bearing potential must agree on using a contraceptive method (oral contraceptive, intra uterine device-IUD, transdermal contraceptive patch) and must have a negative pregnancy urine test at screening; - Signed informed consent. |
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E.4 | Principal exclusion criteria |
- Patients who have been treated with radiotherapy within 1 month before the screening visit; - Unhealed mucositis from any previous treatment; - Chronic inflammatory bowel disease; - Active bacterial, fungal or viral infection; - Pregnant or lactating women; - Male of child-bearing potential who do not use appropriate contraception; - Sero-positivity for HIV; - Participation in any other clinical trial within 30 days of randomization or intention to participate in another clinical trial during participation in this study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Incidence of oral mucositis grade 3 and 4 according to Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 |
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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 | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
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) | 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 | 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 | Yes |
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 | Yes |
E.8.2.3.1 | Comparator description |
- same IMP used at different dosage |
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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 | 18 |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 0 |