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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	EUCTR
Last refreshed on:	19 March 2012
Main ID:	EUCTR2005-000690-22-SE
Date of registration:	20/06/2005
Prospective Registration:	Yes
Primary sponsor:	Clavis Pharma as
Public title:	A phase II Clinical Study of CP-4055 in patients with metastatic melanoma not previous treated with chemotherapy - CP4055-201
Scientific title:	A phase II Clinical Study of CP-4055 in patients with metastatic melanoma not previous treated with chemotherapy - CP4055-201
Date of first enrolment:	16/08/2005
Target sample size:	42
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-000690-22
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: no Randomised: no Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no
Phase:

Countries of recruitment
Sweden

Contacts

Name:
Address:
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Email:
Affiliation:

Name:
Address:
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Key inclusion & exclusion 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:
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

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

A phase II clinical study of CP-4055 in patients with metastatic melanoma not previous treated with chemotherapy

Intervention(s)

Product Name: CP-4055 for infusion
Product Code: CP-4055
Pharmaceutical Form: Concentrate for solution for infusion

Primary Outcome(s)

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.

Secondary Outcome(s)

Secondary ID(s)

CP4055-201

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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