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Study of CS-7017 in Colorectal Cancer Patients Who Have Achieved Disease Control Following First-Line Chemotherapy

This study has been completed.
Information provided by (Responsible Party):
Daiichi Sankyo, Inc. Identifier:
First received: September 29, 2009
Last updated: April 13, 2015
Last verified: April 2015
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.

Condition Intervention Phase
Colorectal Cancer Drug: CS-7017 Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind Placebo-Controlled Phase 2 Study of CS-7017 in Colorectal Cancer Patients Who Have Achieved Disease Control Following First-Line Chemotherapy

Resource links provided by NLM:

Further study details as provided by Daiichi Sankyo, Inc.:

Primary Outcome Measures:
  • Compare PFS rate of participants treated with CS-7017 versus placebo. [ Time Frame: 18 weeks ]

Secondary Outcome Measures:
  • Compare overall PFS of participants treated with CS-7017 versus placebo. [ Time Frame: 18 weeks ]
  • Compare overall survival of participants treated with CS-7017 versus placebo. [ Time Frame: 18 weeks ]

Enrollment: 86
Study Start Date: July 2009
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CS-7017 Drug: CS-7017
Placebo Comparator: Placebo
Placebo matching CS-7017
Drug: Placebo


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00986440

  Show 39 Study Locations
Sponsors and Collaborators
Daiichi Sankyo, Inc.
  More Information

Responsible Party: Daiichi Sankyo, Inc. Identifier: NCT00986440     History of Changes
Other Study ID Numbers: CS7017-A-E201
Study First Received: September 29, 2009
Last Updated: April 13, 2015

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antineoplastic Agents processed this record on September 21, 2017