E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Metastatic Castration Refractory Prostate Cancer |
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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 | 10007453 |
E.1.2 | Term | Carcinoma of the prostate 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 |
The primary objective of this study is to compare treatment Arm A (IMC-3G3 plus mitoxantrone plus prednisone) and Arm B (mitoxantrone plus prednisone) in terms of progression-free survival (PFS). |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of this study are to: Compare the overall survival (OS) of both arms Compare the objective response rate (ORR), according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v.1.1) of both arms Evaluate the prostate-specific androgen (PSA) doubling time in both arms and evaluate the PSA response rate according to two definitions: 1) response manifested by a 50% decline in pretreatment PSA and 2) response defined by a 30% decline in pretreatment PSA at 12 weeks Assess the safety and tolerability of IMC-3G3 (with prednisone) with and without mitoxantrone Explore circulating tumor cells (CTC) in whole blood and PDGFRα expression, and their associations with efficacy endpoints Examine the pharmacokinetics (PK) of IMC-3G3 in combination with mitoxantrone and prednisone and immunogenicity of IMC-3G3. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. The patient has histologically-confirmed adenocarcinoma of the prostate. 2. The patient has radiographic evidence of metastatic prostate cancer (stage M1 or D2). 3. The patient has prostate cancer unresponsive or refractory to medical or surgical castration with a serum testosterone level of < 50 ng/mL (castration-refractory). If the method of castration is luteinizing hormone releasing hormone (LHRH) agonists, the patient must be willing to continue the use of LHRH agonists during protocol treatment. |
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E.4 | Principal exclusion criteria |
1. The patient has a concurrent active malignancy other than adequately treated nonmelanomatous skin cancer or other noninvasive or in situ neoplasms. A patient with previous history of malignancy is eligible provided that there has been no evidence of disease recurrence during the prior 3 years. 2. The patient has received more than 1 prior cytotoxic chemotherapy regimen for metastatic disease. (Patients who have had a treatment break followed by a second docetaxel-based regimen with subsequent disease progression are eligible.) 3. The patient has received prior therapy with mitoxantrone for advanced prostate cancer. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Progression-Free survival |
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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 | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
patient-reported outcomes, explanatory biomarker analyses |
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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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
arm B patients can transfer to 3G3 + prednisone after progression of disease |
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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 | Yes |
E.8.2.3.1 | Comparator description |
Standard of care Mitoxantrone and Prednisone |
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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 | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 50 |
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 | 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
|
Lo studio sara`a considerate finito quando lo studio sara` terminato da ImClone o quando uno dei criteri descitti nel protocollo saranno incontrati |
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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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
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 |