E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Advanced hormone - and chemotherapy - resistant prostate cancer |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
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 objective response rate (ORR) of temsirolimus in patients with advanced hormone- and chemotherapy-resistant prostate cancer |
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E.2.2 | Secondary objectives of the trial |
• To evaluate the median Time To Progression (TTP) and overall survival (OS) of temsirolimus in patients with advanced hormone- and chemotherapy-resistant prostate cancer. • To evaluate the safety and tolerability of temsirolimus in this patient population
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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 |
Explore the correlations of potential biomarkers ( immunosuppressive cells and circulating tumor cells) with clinical outcome’s parameters.
Version 1.0 - Dated 2011-05-03 |
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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 0-2 (see Appendix I) 5. Patients must be >18 and ≤80 years 6. life expectancy >=3 months 7. signed informed consent 8. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures. 9. 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 or billirubin>1.5 the upper limit of normal (ULN) 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. 8. Current treatment with therapeutic doses of Coumadin (low dose Coumadin up to 2 mg PO daily for deep vein thrombosis prophylaxis is allowed). 9. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness. 10. Concurrent treatment with other experimental drugs and/or anticancer agents 11. 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. 12. 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 13. 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) |
• Objective Response Rate (ORR) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After the treatment completion |
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E.5.2 | Secondary end point(s) |
• Overall Survival (OS) • Time to Progression (TTP) • Safety
For the translational research: • Evaluation of angiogenic factors, measurement of circulating tumor cells, and enumeration of immunosuppressive cells (Tregs, MDSCs, Thy17). |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | 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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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 | No |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 24 |
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 |