Clinical Study of Previously Untreated Patients With Malignant Melanoma

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clavis Pharma

Criteria

Inclusion Criteria:

• 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:

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:

• 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