E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Metastatic Colorectal Adenocarcinoma. -----------------------------------------------
Adenocarcinoma Colorectal Metastásico. |
|
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 | 10052362 |
E.1.2 | Term | Metastatic colorectal cancer |
|
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 compare overall survival (OS) with TroVax vs. Placebo in patients with metastatic colorectal cancer receiving standard of care (SOC) in first line treatment. |
|
E.2.2 | Secondary objectives of the trial |
- To compare PFS between TroVax and Placebo arms. - To compare Objective Response rate (ORR) between TroVax and Placebo arms. - To assess the safety and tolerability of TroVax and Placebo arms. |
|
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 |
Exploratory endpoint of the main protocol, version 2.0 dated on 19-11-2007: - To assess the immunologic response (5T4 and MVA antibody titers and T-cells) in a subgroup of this patient population (in selected centers). |
|
E.3 | Principal inclusion criteria |
- Patients with histology/cytology confirmed colorectal adenocarcinoma - Metastatic colorectal cancer - No prior palliative chemotherapy - Patient's informed consent obtained, signed and dated. |
|
E.4 | Principal exclusion criteria |
* Related to study methodology - Age < 18 years old - ECOG performance status > 2 - (Neo)Adjuvant chemotherapy if <6 months between end of chemotherapy and relapse. - Prior Radiotherapy (< 6 weeks) or surgery (< 3 weeks) before randomization - Patients with resectable liver or lung metastasis - Known brain metastasis or leptomeningeal disease - History of other neoplasms - Life expectancy < 3 months - Any contraindication to administer the chosen SOC
* Exclusion criteria related to Standard of Care
* Exclusion criteria related to TroVax - Lymphocytes < 1 x 10e9/L - Serious infection within 28 days prior to randomization - History of hypersensitivity to vaccinia vaccination, egg protein or neomycin - Known positive test to HIV or active and/or requiring treatment hepatitis B or C - Active eczema with lesions on the skin |
|
E.5 End points |
E.5.1 | Primary end point(s) |
- Overall survival defined as the time interval from the date of randomization to the date of death due to any cause. In absence of confirmation of death, survival time will be censored at the earlier of the last date the patient is known to be alive and the study cut-off date. |
|
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 | Yes |
E.6.13.1 | Other scope of the trial description |
|
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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
| 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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 63 |
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 |
|
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
|
The termination of the study and the final cut-off date for survival will be the date when it is determined that approximately 844 deaths have occurred. |
|
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 |
E.8.9.2 | In all countries concerned by the trial years | 5 |
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 |