E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
oral mucositis in renal cell carcinoma, hepatocellular carcinoma, and gastrointestinal stromal tumor |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10028127 |
E.1.2 | Term | Mucositis |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10042128 |
E.1.2 | Term | Stomatitis |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10042128 |
E.1.2 | Term | Stomatitis |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10031009 |
E.1.2 | Term | Oral pain |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10031009 |
E.1.2 | Term | Oral pain |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10013911 |
E.1.2 | Term | Dysgeusia |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10013911 |
E.1.2 | Term | Dysgeusia |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10013950 |
E.1.2 | Term | Dysphagia |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10013950 |
E.1.2 | Term | Dysphagia |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10013781 |
E.1.2 | Term | Dry mouth |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10013781 |
E.1.2 | Term | Dry mouth |
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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 Caphosol® oral rinse on clinical outcomes of selected oral symptom burden (oral mucositis/stomatitis (aphthous-like), oral pain, taste change (dysgeusia), difficulty swallowing (dysphagia), difficulty oral intake, and dry mouth) associated with incidence of grade ≥ 1 oral adverse events and the anticancer therapy cessation in patients treated with selected targeted anticancer therapy in selected tumors. |
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E.2.2 | Secondary objectives of the trial |
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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 |
Explorative analysis of polymorphism for Matrix metalloproteinases (MMPs) and genes encoding for pharmacokinetic and pharmacodynamic variables related to the pharmacodynamics of the targeted anticancer agents
A blood sample will be obtained during a routine vena puncture planned for other medical reasons, so no extra vena puncture is necessary (see study flow chart). We will draw one EDTA tube (5 cc) when the patient enters onto the study. DNA will be isolated for the purpose of a pathway genotype analysis of enzymes and transporters with putative relevance for targeted agents pharmacokinetics/dynamics, as outlined above. So genetic testing related to inheritable disease risk will be performed.
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E.3 | Principal inclusion criteria |
Male and female subjects ≥18 years of age Histological proof of RCC, HCC or GIST Oral adverse events > grade 0 due to sunitinib, sorafenib, pazopanib, temsirolimus, or everolimus in mono therapy at study entry Written informed consent Eastern Co-operative Oncology Group (ECOG) performance status ≤ 2 Able to perform oral rinsing Able to complete questionnaires by themselves or with assistance
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E.4 | Principal exclusion criteria |
Subjects meeting any of the following criteria will be excluded from the study: Any previous systemic antineoplastic treatment within 4 weeks of initiation of current targeted anticancer therapy Current antineoplastic combination cytotoxic chemotherapy therapy Physiologic condition that precludes the use of an oral rinse Hypersensitivity to Caphosol ingredients Use of palifermin, oral cryotherapy, low level laser therapy, topical oral steroids within 3 weeks of current targeted anticancer therapy Oral abnormalities defined as baseline oral assessment of NCI-CTCAE v4.0 grade > 0 Current use of agents that are known to be strong inducers or inhibitors of CYP3A4 that can not be stopped
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E.5 End points |
E.5.1 | Primary end point(s) |
Assess the severity of patient-reported oral adverse events as determined by the change in the VHNSS2.0 score 3 times a week, from onset of oral mucositis, stomatitis (aphthous-like), oral pain, taste change (dysgeusia), difficulty swallowing (dysphagia), difficulty oral intake, or dry mouth during the active oral rinse period with Caphosol® oral rinse versus NaCl 0.9% oral rinse, 4 times daily, 2 minutes with 30 ml solution |
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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 | No |
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 | 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) | 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 | Yes |
E.8.1.6 | Cross over | Yes |
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.8.4.1 | 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 | 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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Since all patients rinse two periods for each two weeks we expect all patients to reach the end of the trial. If oral mucositis/stomatitis doesn't re-appear, and a patient can't start with te second rinse periode, this will be noted. |
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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 | 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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |