Status:
COMPLETED
Clinical Study of Previously Untreated Patients With Malignant Melanoma
Lead Sponsor:
Clavis Pharma
Conditions:
Malignant Melanoma
Neoplasm Metastasis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 o...
Detailed Description
This is an international multicentre phase II clinical study conducted in the USA and Europe. Previously untreated patients over 18 years, with metastatic malignant melanoma are eligible for inclusion...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2007
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00232726
Start Date
September 1 2005
End Date
July 1 2007
Last Update
July 10 2007
Active Locations (3)
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1
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213-2584
2
The Norwegian Radium Hospital
Oslo, Norway, NO-0310
3
University Hospital
Lund, Sweden, SE-221 85