Clinical Study of Previously Untreated Patients With Malignant Melanoma

Completed · Phase 2

Conditions studied: Malignant Melanoma, Neoplasm Metastasis

In brief

Previously untreated patients with malignant melanoma receive a new chemotherapy drug currently under development. CP-4055 is given intravenously on days 1-5 every four weeks until complete response or disease progression.

Key facts

Study ID

NCT00232726

Run by

Clavis Pharma

People needed

42

Starts

2005-09-01

Expected to finish

2007-07-01

Last updated by the study team

2007-07-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with histologically or cytologically confirmed stage IV or unresectable stage III non-ocular malignant melanoma who have not undergone prior chemotherapy for the treatment of melanoma (chemotherapy-naïve)
• 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:
• Neutrophils ≥ 1.5 x 10\^9/L
• Platelets ≥ 100 x 10\^9/L
• Hemoglobin (Hb) ≥ 10 g/dL
• Hepatic function:
• AST/ALT ≤ 2.5 times institutional upper limit of normal (ULN). If liver metastases, ≤ 5 times institutional ULN.
• Serum bilirubin and alkaline phosphatase ≤ 1.5 times institutional ULN
• Renal function:
• Creatinine ≤ 1.5 times institutional ULN

You may not qualify if…

• Known brain metastases
• 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

Where it is running

• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• The Norwegian Radium Hospital — Oslo, Norway
• University Hospital — Lund, Sweden

Full record on ClinicalTrials.gov

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