A phase II Clinical Study of CP-4055 in patients with metastatic melanoma not previous treated with chemotherapy - CP4055-201
- Conditions
- A phase II clinical study of CP-4055 in patients with metastatic melanoma not previous treated with chemotherapy
- Registration Number
- EUCTR2005-000690-22-SE
- Lead Sponsor
- Clavis Pharma as
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 42
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>- Time to progression<br>- Duration of tumour response<br>- Safety and tolerability <br>of the CP-4055 treatment<br>;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.<br>The Response Rate (= PR + CR) will be estimated and a 95 % confidence interval calculated. <br>
- Secondary Outcome Measures
Name Time Method