E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with advanced hormone resistant and chemotherapy resistant prostate 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 |
To evaluate the efficacy of Sunitinib in patients with advanced hormone resistant and chemotherapy resistant prostate cancer in terms of response rate. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the efficacy of Sunitinib in patients with advanced hormone resistant and chemotherapy resistant prostate cancer in terms of Time To Progression and Survival |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Histologically or cytologically confirmed prostate cancer in relapse 2.Laboratory confirmation of hormone resistance by measuring LH, FSH, DHEA, testosterone. 3.Continued increase of PSA despite adequate androgen blockade and administration of at least one line of chemotherapy (docetaxel, vinorelbine). 4.ECOG Performance Status 0, 1 or 2 (see Appendix I) 5.Patients must be >18 and ≤80 years 6.Life expectancy ≥3 months 7.Provision of informed consent 8.Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures. Patients with both measurable and non measurable disease will be allowed to enter the trial and will be followed for response as described in Section 6.1.1 of the protocol.
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E.4 | Principal exclusion criteria |
1.Concomitant use of any other antineoplastic treatment with the exception of LHRH inhibitors and bisphosphonates for the treatment of bone metastases 2.Chronic active hepatitis or cirrhosis 3.Active infection, cachexia or serious psychiatric disease 4.Isolated recurrent disease that may be amenable to local therapy eg, surgical intervention or radiation therapy 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.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. 8.Ongoing cardiac dysrhythmias of grade 2, atrial fibrillation of any grade, or QTc interval >450 msec for males or >470 msec for females. 9.Hypertension that cannot be controlled by medications (>150/100 mm/Hg despite optimal medical therapy). 10.Current treatment with therapeutic doses of Coumadin (low dose Coumadin up to 2 mg PO daily for deep vein thrombosis prophylaxis is allowed). 11.Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness. 12.Concurrent treatment with other experimental drugs and/or anticancer agents 13.Patients must be surgically sterile, or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate. 14.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 15.Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary endpoint: • Objective Response Rate (ORR)
Secondary endpoint: • Survival • Time to Progression (TTP) • Safety
Exploratory endpoint • Plasma protein levels (including but not limited to VEGF, and sVEGFR2) that may be associated with tumor proliferation, angiogenesis, or sunitinib mechanism of action
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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 | 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) | 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 | Yes |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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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The clinical trial will be completed when sufficient number of patients will be enrolled in this trial and all they will have complete their treatment. |
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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 | 5 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |