Study of CS-7017 in Colorectal Cancer Patients Who Have Achieved Disease Control Following First-Line Chemotherapy
Tracking Information
Start Date ICMJE | July 2009 |
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Estimated Primary Completion Date | July 2011 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: September 29, 2009) | Compare PFS rate of participants treated with CS-7017 versus placebo. [ Time Frame: 18 weeks ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | No Changes Posted |
Current Secondary Outcome Measures ICMJE (submitted: September 29, 2009) |
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Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | Study of CS-7017 in Colorectal Cancer Patients Who Have Achieved Disease Control Following First-Line Chemotherapy |
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Official Title ICMJE | 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 |
Brief 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. |
Detailed Description | |
Study Phase | Phase II |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Condition ICMJE | Colorectal Cancer |
Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 170 |
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Estimated Completion Date | February 2012 |
Estimated Primary Completion Date | July 2011 (final data collection date for primary outcome measure) |
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both |
Ages | 18 Years and older |
Accepts Healthy Volunteers | No |
Contacts ICMJE | |
Location Countries ICMJE | Czech Republic, France, Germany, Italy, Poland, Russian Federation, Spain, Ukraine, United Kingdom |
Administrative Information
NCT ID ICMJE | NCT00986440 |
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Responsible Party | Manager, Clinical Development, Daiichi Sankyo Pharma Development |
Study ID Numbers ICMJE | CS7017-A-E201 |
Study Sponsor ICMJE | Daiichi Sankyo Inc. |
Collaborators ICMJE | |
Investigators ICMJE | |
Information Provided By | Daiichi Sankyo Inc. |
Source: http://clinicaltrials.gov/