A phase II clinical study of CP-4055 in patients with metastatic melanoma not previous treated with chemotherapy
Conditions
Interventions
Sponsors
Clavis Pharma as
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with histologically or cytologically confirmed stage IV or unresectable stage III non-ocular malignant melanoma who have not undergone prior chemotherapy (chemotherapy-naive) 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. 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 = 2.5 times institutional upper limit of normal (ULN). If liver metastases, = 5 times institutional ULN b. Serum bilirubin and alkaline phosphatase = 1.5 times institutional ULN • Renal function: Creatinine = 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. Diagnosis of ocular malignant melanoma 3. Radiotherapy to more than 30 % of bone marrow 4. Participation in another therapeutic Clinical Study within 30 days of enrolment or during this Clinical Study 5. Prior immuno- and/or chemotherapy including vaccines for the treatment of melanoma 6. Requirement of concomitant treatment with a non-permitted medication: • Alternative drugs • High doses of vitamins 7. History of allergic reactions to Ara-C or egg 8. Presence of any serious concomitant systemic disorders incompatible with the Clinical Study (e.g. uncontrolled inter-current illness including ongoing or active infection) 9. Presence of any significant central nervous system or psychiatric disorder(s) that would hamper the patient’s compliance 10. Pregnancy, breastfeeding or absence of adequate contraception for both male and female fertile patients 11. Known positive status for HIV and/or hepatitis B or C 12. Any reason why, in the Investigator’s opinion, the patient should not participate 13. Drug and/or alcohol abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the objective tumour response in chemotherapy-naive patients with metastatic melanoma when treated with CP-4055 for infusion D1-5/4w.;Secondary Objective: To evaluate the - Time to progression - Duration of tumour response - Safety and tolerability of the CP-4055 treatment ;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
Sweden
Outcome results
None listed