E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Recurrent or metastatic non-nasopharyngeal head and neck cancer |
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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 |
Objective Response Rate (ORR) |
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E.2.2 | Secondary objectives of the trial |
Survival Time to Progression (TTP) Safety Pharmacokinetics |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. histological confirmation of evidence of squamous cell carcinoma of the head and neck diagnosed by biopsy 2. patients must have available tumour tissue for translational research studies 3. Patients could have received any treatment for locoregional disease including surgery, radiotherapy, chemotherapy or any possible combination 4. Patients must be able to ingest capsules per os. 5. female or male patients aged 18 years and over 6. life expectancy ³8 weeks 7. ECOG Performance Status 0, 1 or 2 (see Appendix I) 8. provision of informed consent 9. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
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E.4 | Principal exclusion criteria |
1. carcinomas of the post-nasal space, thyroid, sinus or salivary gland tumours 2. isolated recurrent disease that may be amenable to local therapy eg, surgical intervention or radiation therapy 3. Patients fed through a naso-gastric or a gastric tube. 4. Any prior systemic treatment for recurrent or metastatic disease 5. Major surgery, radiation therapy, or systemic therapy within 4 weeks of starting the study treatment. 6. Diagnosis of any second malignancy, except basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma that has been adequately treated with no evidence of recurrent disease for 12 months. 7. History of or known brain metastases, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease on screening CT or MRI scan. 8. Any of the following within the 12 months prior to starting the study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism. 9. Ongoing cardiac dysrhythmias of grade ³2, atrial fibrillation of any grade, or QTc interval >450 msec for males or >470 msec for females. 10. Hypertension that cannot be controlled by medications (>150/100 mm/Hg despite optimal medical therapy). 11. Current treatment with therapeutic doses of Coumadin (low dose Coumadin up to 2 mg PO daily for deep vein thrombosis prophylaxis is allowed). 12. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness. 13. Concurrent treatment with other experimental drugs and/or anticancer agents 14. Pregnancy or breastfeeding. Patients must be surgically sterile, be postmenopausal, or must agree to use effective contraception during the period of therapy. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrollment. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate. 15. Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into the trial 16. any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy 17. any third space accumulation of fluid (oedema, effusion, ascites)
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E.5 End points |
E.5.1 | Primary end point(s) |
To evaluate the activity of SUTENT in patients with recurrent or metastatic Head and Neck Cancer in terms of response rate |
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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 | Yes |
E.6.7 | Pharmacodynamic | Yes |
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 | 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) | 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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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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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 | |
E.8.9.1 | In the Member State concerned days | |