E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Metastatic prostate cancer |
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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 | 10036909 |
E.1.2 | Term | Prostate cancer metastatic |
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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 determine the efficacy of the combination of ridaforolimus and bicalutamide compared to placebo and bicalutamide by PSA decline within 12 weeks, a surrogate measurement of overall survival efficacy in prostate cancer therapy trials.
To determine the safety and tolerability of ridaforolimus when combined with bicalutamide.
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E.2.2 | Secondary objectives of the trial |
To determine the efficacy of the combination of ridaforolimus and bicalutamide compared to placebo and bicalutamide by PSA response rate.
To determine the efficacy of the combination of ridaforolimus and bicalutamide compared to placebo and bicalutamide by progression free survival (PFS) analysis.
To determine the efficacy of the combination of ridaforolimus and bicalutamide compared to placebo and bicalutamide by time to PSA progression.
To evaluate the pharmacokinetic profile of ridaforolimus when administered in combination with bicalutamide
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patient has histologically confirmed adenocarcinomas of the prostate. 2. Archival pathological material is available for submission to central laboratory. 3. Patient has evidence of metastatic disease at protocol entry or at the time of prior hormonal manipulation, determined radiographically by the presence of at least 2 bone scan lesions consistent with metastases or abdominal/pelvic lymph nodes > 2 cm on longest axial measurement. Solitary or ambiguous bone lesions should be confirmed with plain radiographs or magnetic resonance imaging (MRI). 4. Patient has evidence of disease progression despite castrate levels of testosterone (< 50 ng/dl) following orchiectomy or during therapy with a luteinizing hormone releasing hormone (LHRH) agonist or antagonist (with or without an anti-androgen). Evidence of disease progression must include one of the following: a) Levels of PSA are defined as increasing when at least three consecutive measurements, obtained at least one week apart, show increases. (The minimum starting PSA level for trial entry is 7 ng/mL.) b) Progressive lymph node disease is defined per Response Evaluation Criteria in Solid Tumors (RECIST) criteria. The longest diameter of any node must measure at least 2 cm on spiral computed tomography (CT) to qualify as a target lesion. c) Worsening bone scan is defined as an increase of 2 or more lesions from a previous bone scan. Solitary or ambiguous bone lesions should be confirmed with plain radiographs or MRI. 5. Patient has a PSA >= 7 ng/ml. |
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E.4 | Principal exclusion criteria |
1. Patient has received bicalutamide, flutamide, nilutamide or cyproterone within the past 12 months, except for use of less than 30 days duration during the initiation of LHRH analog therapy. 2. Patient has received prior chemotherapy for metastatic prostate cancer. 3. Patient has previously received rapamycin or rapamycin analogs, including deforolimus, temsirolimus, or everolimus. 4. Patient is receiving corticosteroids administered at doses greater than those used for normal replacement therapy. . 5. Patient is receiving an opioid or narcotic analgesic prescribed for pain due to prostate cancer. 6. In the opinion of the investigator, the patient has pain related to metastatic prostate cancer that warrants the initiation of chemotherapy.
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E.5 End points |
E.5.1 | Primary end point(s) |
Efficacy: 30% PSA decline with 12 weeks: defined as a >=30% decline from baseline with the first 12 weeks of study treatment. The decline is determined by the lowest post-baseline PSA value with the first 12 weeks.
Safety: Tolerability will be assessed by clinical review of all relevant adverse experiences and monitoring variables related to laboratory measurements, physical examinations, and vital signs. |
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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 | 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 | 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 | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 26 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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
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Last Visit of Last Patient |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 10 |
E.8.9.2 | In all countries concerned by the trial days | 0 |