E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Stage IV Colorectal Cancer |
|
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 | 10010035 |
E.1.2 | Term | Colorectal cancer stage IV |
|
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 the progression free survival (PFS) rate of colorectal cancer patients treated with CS-7017 or placebo at 18 weeks in patients who had achieved a response of CR, PR or SD from first line therapy with FOLFOX or FOLFIRI. |
|
E.2.2 | Secondary objectives of the trial |
1. Compare the overall PFS and overall survival (OS) of patients treated with CS-7017 or placebo; and 2. Compare the safety of patients treated with CS-7017 or placebo Exploratory Objectives: The exploratory objectives of the study are to: 1. Evaluate changes relative to study treatment for plasma/serum biomarkers associated with the activity of PPAR-gamma including adiponectin, VEGF and caspase 3/7; 2. Evaluate the expression of baseline tumor biomarkers including PPAR-gamma/retinoid X receptor (RXR), adiponectin receptor, p21, pErk and pAkt using archive tumor; 3. Profile critical genes in tumor using archived tumor (mRNA expression and DNA mutation analysis), e |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients with histologically-confirmed, metastatic or advanced CRC; Patients will have received first line combination chemotherapy (folinic acid + fluoropyrimidine + oxaliplatin (FOLFOX) or folinic acid + fluoropyrimidine + Irinotecan (FOLFIRI)), until maximal benefit has been reached, i.e. one cycle after which they have achieved their best response, CR, PR or stable disease (SD). Patients will enter the trial within 8 weeks after completing 1st line therapy. A minimum of one unidimensionally measurable target lesion according to RECIST unless CR was achieved; Age ≥ 18 years and ECOG performance status (PS) ≤ 2 at study entry; Female subjects must be surgically sterile, postmenopausal, or using acceptable non-hormonal contraception; Adequate organ and bone marrow function as assessed by clinical laboratory evaluations. |
|
E.4 | Principal exclusion criteria |
Anticipation of a need for major surgery or radiotherapy during the treatment period; Any of the following clinically significant conditions within 6 months before enrolment: myocardial infarction, NYHA Class II or higher severe/unstable angina pectoris, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, or other clinically significant thromboembolic event; clinically significant pulmonary disease (e.g., severe COPD or asthma); clinically significant pulmonary oedema; Brain metastasis; Clinically significant pleural or pericardial effusions; Clinically significant active infection requiring antibiotic or antiretroviral therapy; Medical history of diabetes mellitus requiring treatment with insulin or oral agents; malabsorption syndrome, chronic diarrhoea (lasting ≥ 4 weeks duration), inflammatory bowel disease, or partial bowel obstruction; Concomitant use of other thiazolidinediones (TZDs); Serious intercurrent medical illnesses which, in the opinion of the Investigator, would impair the ability to give informed consent or unacceptably reduce the safety of the proposed treatment. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint for this study is the rate of progression free survival (PFS) at 18 weeks. |
|
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 | 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 | Yes |
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 | 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
| 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 | 28 |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 6 |