A phase II clinical study of ELACYT as second line therapy in patients with advanced colorectal cancer
Conditions
Interventions
Product Name: CP-4055 for infusion
Product Code: CP-4055
Pharmaceutical Form: Concentrate for solution for infusion
Sponsors
Clavis Pharma ASA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with histologically or cytologically confirmed metastatic colorectalcancer who have failed a first line chemotherapeutic regimen containing oxaliplatin and 5-fluorouracil (5-FU) (with or without bevazumiab) 2. Measurable disease according to Response Criteria for Solid Tumors (RECIST) 3. Performance Status 0 – 2 according to ECOG (Eastern Cooperative Oncology Group) Performance Status 4. Age 18 years or more 5. Life expectancy > 3 months 6. Signed informed consent 7. Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must have a negative serum or urine pregnancy test within 2 weeks prior to beginning treatment on this study. Nursing patients are excluded. 8. Male and female patients must use acceptable contraceptive methods for the duration of time on study, and males also for 3 months after the last CP-4055 dose 9. Adequate haematological and biological functions: • Bone marrow function: a. Neutrophils above or equal to 1.5 x 109/L b. Platelets above or equal to 100 x 109/L c. Hb above or equal to 10 g/dL • Hepatic function: a. AST/ALT below or equal to 2.5 times institutional upper limit of normal (ULN). If liver metastases, below or equal to 5 times institutional ULN b. Serum bilirubin below or equal to 1.5 times institutional ULN • Renal function: Creatinine below or equal to 1.5 times institutional ULN Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Known brain metastases 2. Radiotherapy to more than 30 % of bone marrow 3. Participation in another therapeutic Clinical Study within 30 days of enrolment or during this Clinical Study 4. Requirement of concomitant treatment with a non-permitted medication: • Alternative drugs • High doses of vitamins 5. History of allergic reactions to Ara-C or egg 6. Presence of any serious concomitant systemic disorders incompatible with the Clinical Study (e.g. uncontrolled inter-current illness including ongoing or active infection) 7. Presence of any significant central nervous system or psychiatric disorder(s) that would hamper the patient’s compliance 8. Pregnancy, breastfeeding or absence of adequate contraception for both male and female fertile patients 9. Known positive status for HIV and/or hepatitis B or C 10. Drug and/or alcohol abuse 11. Any reason why, in the Investigator’s opinion, the patient should not participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the objective tumour response in patients with advanced colorectal cancer when treated with CP-4055 for infusion D1-5/4w.; Secondary Objective: To evaluate the - Time to progression - Duration of response - Characterize the quantitative and qualitative toxicities of the CP-4055 treatment in this patient popoulation ; Primary end point(s): Tumour response defined as Complete Response (CR) and/or Partial Response (PR), characterized by measuring the target lesions, and according to the RECIST criteria. The Response Rate (= PR + CR) will be estimated and a 95 % confidence interval calculated. | — |
Countries
United Kingdom
Outcome results
None listed