Study of CS-7017 in Colorectal Cancer Patients Who Have Achieved Disease Control Following First-Line Chemotherapy
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: CS-7017; Placebo
Intervention description: CS-7017; Placebo
Intervention MeSH terms: Efatutazone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 84.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Monotherapy treatment with CS-7017 to assess progression-free-survival (PFS) of subjects who
      achieved an objective response of Disease Control on first line therapy with Folinic acid
      (leucovorin), Fluorouracil (5-FU), Oxaliplatin (Eloxatin) known as FOLFOX; or Folinic acid
      (leucovorin), Fluorouracil (5-FU), irinotecan (Camptosar) known as FOLFIRI.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with histologically confirmed, metastatic CRC that have achieved confirmed
             maximal benefit of DC following treatment with standard first line chemotherapy of a
             5-fluoropyrimidine plus either oxaliplatin or irinotecan. Patients should be entered
             onto this trial within 8 weeks of completing first line therapy;

          -  If CR was not achieved: measurable disease, i.e. at minimum one
             unidimensionally-measurable target lesion according to RECIST (Response Evaluation
             Criteria in Solid Tumors);

          -  Age >= 18 years and Eastern Cooperative Oncology Group (ECOG) performance status (PS)
             =< 2 at study entry;

          -  Resolution of any toxic effects of prior therapy (except alopecia) to NCI CTCAE,
             Version 3.0, grade =< 1;

          -  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 <2.5 x ULN if without liver metastasis and =< 5.0 x
                  ULN if liver metastasis;

               -  Total bilirubin =< 2.0 x ULN;

               -  Prothrombin time (PT)/International Normalised Ratio (INR) within normal limits
                  (WNL) unless therapeutically anticoagulated;

          -  Women of childbearing potential and men must be willing to consent to using highly
             effective methods of contraception (eg, hormonal contraceptives, bilateral tubal
             ligation, barrier with spermicide, intrauterine device) while on treatment and for at
             least 3 months thereafter;

          -  Males with the potential to father children must use two of the following methods of
             contraception acceptable for the study (e.g. hormonal contraceptives, bilateral tubal
             ligation, barrier with spermicide, intrauterine device) while on trial treatment and
             for at least 3 months thereafter.

          -  All female subjects of childbearing potential must have a negative pregnancy test
             (plasma or urine) result within 7 days before initiating study treatment;

          -  Baseline laboratory tests and tumor assessments must have been performed within 2
             weeks before initiating study treatment;

          -  Subjects must be fully informed about their illness and the investigational nature of
             the study protocol (including foreseeable risks and possible side effects) and must
             sign and date an IEC-approved ICF before performance of any study specific procedures
             or tests.

        Exclusion Criteria:

          -  Anticipation of need for a major surgical procedure or RT during the study;

          -  Treatment 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.

          -  History of any of the following conditions: diabetes mellitus requiring treatment with
             insulin or oral agents;

          -  Concomitant use of other TZDs;

          -  Myocardial infarction with significant impairment of cardiac function (e.g., ejection
             fraction =< 50%); severe/unstable angina pectoris; coronary/peripheral artery bypass
             graft; congestive heart failure; cerebrovascular accident (CVA) or transient ischemic
             attack (TIA), pulmonary embolism, or other clinically significant thromboembolic
             event; clinically significant pulmonary disease (e.g., severe chronic obstructive
             pulmonary disease [COPD] or asthma);

          -  Brain metastasis; an uncontrolled seizure disorder; spinal cord compression; or
             carcinomatous meningitis;

          -  Pleural or pericardial effusion. Subjects with minimal pleural effusion may be
             eligible upon request by Investigator and approval by Sponsor;

          -  Clinically significant active infection that requires antibiotic therapy or Human
             Immunodeficiency Virus (HIV) positive subjects receiving antiretroviral therapy;

          -  Pregnant or breast feeding;

          -  Known history of severe hypersensitivity reactions to any of the components of CS 7017
             formulations;

          -  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;