Clinical Study of Previously Untreated Patients With Malignant Melanoma
NCT ID: NCT00232726
Last Updated: 2007-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
42 participants
INTERVENTIONAL
2005-09-30
2007-07-31
Brief Summary
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Detailed Description
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The new development drug CP-4055 is administered for five consecutive days (Day 1 to 5) in a 4 week schedule (one cycle). The dose is 200 mg/m2/day.
A patient will continue treatment until complete response or until (s)he is withdrawn from the Clinical Study because of disease progression, unacceptable toxicity or any other reason described in the clinical study protocol.
Efficacy is assessed at baseline and end of every second cycle with CT or MRI.
Safety assessments are done at each visit. Blood samples are taken and haematological and biochemical parameters are assessed for safety.
Any adverse events are recorded and reported.
The clinical study has been approved by the relevant Independent Ethical Committees/Institutional Review Boards and Concerned Regulatory Authority as appropriate. It is conducted according to ICH Good Clinical Practice, the Declaration of Helsinki, and applicable national law and regulations.
Patients who give an additional consent will have two additional, and not mandatory, procedures performed:
* Biopsy (tissue sample) from particular tumours (taken only at baseline for identification of tumour genes)
* Serum samples (from blood drawn at baseline and at end of the cycle 2 for protein sequences analyses, proteomics)
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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CP-4055 (ELACYT)
Eligibility Criteria
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Inclusion Criteria
* Measurable disease according to Response Criteria in Solid Tumours (RECIST)
* Performance Status 0 - 2 according to ECOG (Eastern Cooperative Oncology Group) Performance Status
* Age 18 years or more
* Life expectancy \> 3 months
* Signed informed consent
* Adequate haematological and biological functions:
* Bone marrow function:
1. Neutrophils ≥ 1.5 x 10\^9/L
2. Platelets ≥ 100 x 10\^9/L
3. Hemoglobin (Hb) ≥ 10 g/dL
* Hepatic function:
1. AST/ALT ≤ 2.5 times institutional upper limit of normal (ULN). If liver metastases, ≤ 5 times institutional ULN.
2. Serum bilirubin and alkaline phosphatase ≤ 1.5 times institutional ULN
* Renal function:
* Creatinine ≤ 1.5 times institutional ULN
Exclusion Criteria
* Diagnosis of ocular malignant melanoma
* Radiotherapy to more than 30% of bone marrow
* Participation in another therapeutic clinical study within 30 days of enrolment or during this clinical study
* Prior immunotherapy and/or chemotherapy for the treatment of melanoma
* Requirement of concomitant treatment with a non-permitted medication:
* Alternative drugs
* High doses of vitamins
* History of allergic reactions to Ara-C or egg
* Presence of any serious concomitant systemic disorders incompatible with the clinical study (e.g. uncontrolled intercurrent illness including ongoing or active infection)
* Presence of any significant central nervous system or psychiatric disorder(s) that would hamper the patient's compliance
* Pregnancy, breastfeeding, or absence of adequate contraception for both male and female fertile patients
* Known positive status for HIV and/or hepatitis B or C
* Drug and/or alcohol abuse
* Any reason why, in the Investigator's opinion, the patient should not participate
18 Years
ALL
No
Sponsors
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Clavis Pharma
INDUSTRY
Principal Investigators
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Svein Dueland, MD, Ph.D
Role: PRINCIPAL_INVESTIGATOR
The Norwegian Radium Hospital, Montebello, NO-0310 Oslo, Norway
Locations
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University of Pittsburgh
Pittsburgh, Pennsylvania, United States
The Norwegian Radium Hospital
Oslo, , Norway
University Hospital
Lund, , Sweden
Countries
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Related Links
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Sponsor's home page
Other Identifiers
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CP4055-201
Identifier Type: -
Identifier Source: org_study_id