CS7017 in CR Cancer Patients with Disease Control post 1stLine Therapy

• Research type

  Research Study

• Full title

  A Randomised, Double-Blind, Placebo-Controlled Phase 2 Study of Cs-7017 In Colorectal Cancer Patients Who Have Achieved Disease Control Following First-Line Chemotherapy

• IRAS ID

  18597

• Eudract number

  2008-005848-16

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Approximately 50% of patients with metastatic colorectal cancer will achieve a maximal tumour response of complete response or partial response and a further 20% will attain stable disease within 3-6 months of first line standard therapy. The benefit of continued treatment beyond this point has remained somewhat controversial. The purpose of this study is to compare the progression free survival (PFS) at 18 weeks of colorectal cancer patients treated with CS-7017 or placebo who have previously achieved a response of disease control to standard first line therapy. Based on data obtained from animal trials it is thought that CS-7017 is less toxic and might prolong PFS in patients with metastatic colorectal cancer, who have achieved disease control after first line chemotherapy. To be eligible to take part in this trial amongst other factors patients must have achieved a complete response, partial response or stable disease from first line therapy and must be over the age of 18. It is estimated that 170 subjects will be enrolled and enrolment will be completed in 18-24 months. Patients will continue treatment with CS-7017 for at least 8 cycles. Patients will be randomised and will be given either CS-7017 or placebo. Patients will self-administer 2 tablets twice daily. Each treatment cycle will last for three weeks. Assessments will be performed at baseline, at the end of every 2 cycles (6 weeks), End of treatment. Treatment will continue at the study doctor??s discretion or if the patient withdraws consent to participate in the study. Patients will be followed-up for every 3 months after last dose of study drug or study discontinuation. If at the end of the study, the patient is responding well and wishes to continue treatment with CS-7017, they will have the option to enrol in an open-label CS-7017 study.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  09/H0717/34

• Date of REC Opinion

  30 Jun 2009

• REC opinion

  Further Information Favourable Opinion