Stage III and IV Colorectal Cancer MedDRA version: 13.1 Level: PT Classification code 10010035 Term: Colorectal cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: CS-7017
Product Code: CS-7017
Pharmaceutical Form: Film-coated tablet
CAS Number: 1048002-36-3
Current Sponsor code: CS-7017
Other descriptive name: CS7017
Concentration unit: mg milligr
Sponsors
Daiichi Sankyo Development Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with histologically-confirmed, metastatic or locally advanced CRC (stages III or IV) and must have received standard first line combination chemotherapy: a) Patients must receive their primary treatment until 1 cycle beyond their best response (disease control) has been reached, i.e., CR, PR or SD as determined by the Investigator; b) Patients must enter the trial within 8 weeks after completing first line therapy; c) Standard first line combination chemotherapy can consist of a fluoropyrimidine based regimen: i) FOLFOX (folinic acid + fluoropyrimidine + oxaliplatin); or ii) FOLFIRI (folinic acid + fluoropyrimidine + Irinotecan); or iii) Other fluoropyrimidine based regimens, e.g., XELOX (capecitabine + oxaliplatin) and the use of a fluoropyrimidine based regimen; iv) Also, a biological adjunct such as bevacizumab is allowed in combination with such fluoropyrimidine based regimens; 2. A minimum of one unidimensionally-measurable target lesion according to RECIST (Response Evaluation Criteria in Solid Tumors, Version 1.0);20, unless CR was achieved; 3. Age = 18 years and Eastern Cooperative Oncology Group (ECOG) performance status = 2 at study entry; 4. Resolution of any toxic effects of prior therapy (except alopecia) to NCI CTCAE, Version 3.0, grade = 1; 5. Adequate organ and bone marrow function as evidenced by: · Haemoglobin = 10 g/dL (transfusion and/or growth factor support allowed); · Absolute neutrophil count (ANC) = 1.5 x 109/L; · Platelet count = 100 x 109/L; · Serum creatinine = 1.5 x ULN or creatinine clearance >60 mL/min; · AST and alkaline phosphatase =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Anticipation of need for a major surgical procedure or radio therapy during the study; 2. Treatment for cancer with chemotherapy, hormonal therapy, minor surgery, or any investigational agent within 4 weeks before study enrolment. Treatment with immunotherapy, biological therapy, or major surgery within 6 weeks before study enrolment. Treatment with RT within 1 week before study enrolment. 3. History of any of the following conditions: diabetes mellitus requiring treatment with insulin or oral agents, malabsorption syndrome, chronic diarrhoea (lasting =4 weeks duration), inflammatory bowel disease, or partial bowel obstruction; 4. Concomitant use of other TZDs; 5. Any of the following clinically significant conditions within 6 months before enrolment: myocardial infarction, NYHA Class II or higher severe/unstable angina pectoris (See Section 17.2), 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 severe asthma); clinically significant pulmonary oedema; 6. Brain metastasis; an uncontrolled seizure disorder; spinal cord compression; or carcinomatous meningitis; 7. Clinically significant pleural or pericardial effusion. Subjects with minimal pleural effusion may be eligible upon request by Investigator and approval by Sponsor; 8. Clinically significant active infection that requires antibiotic therapy or Human Immunodeficiency Virus (HIV) positive subjects receiving antiretroviral therapy; 9. Pregnant or breast feeding; 10. Known history of severe hypersensitivity reactions to any of the components of CS 7017 formulations; 11. Serious intercurrent medical or psychiatric illnesses or any other conditions that in the opinion of the Investigator would impair the ability to give informed consent or unacceptably reduce protocol compliance or safety of the study treatment;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 18 weeks.;Main Objective: The primary objective is to compare the progression free survival (PFS) rate of colorectal cancer patients treated with CS-7017 or placebo at 18 weeks in patients who have achieved a response of disease control (complete response [CR],partial response [PR] or stable disease [SD]) to standard first line therapy.;Secondary Objective: 1/ Compare the overall PFS and overall survival (OS) of patients treated with CS-7017 or placebo and 2/ Compare the safety parameters of patients treated with CS-7017 or placebo 3/ Pharmacokinetic Objectives: The pharmacokinetic objective is to analyse the population PK of CS-7017. ;Primary end point(s): The primary endpoint for this study is the rate of progression free survival (PFS) at 18 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints for this study are PFS and overall survival and safety endpoints (ie, AEs and clinical laboratory evaluations).;Timepoint(s) of evaluation of this end point: Overall survival. | — |
Countries
Czech Republic, France, Germany, Italy, Poland, Russian Federation, Spain, Ukraine, United Kingdom
Contacts
Public ContactClinical Trial Information
Daiichi Sankyo Development Ltd
Outcome results
None listed