A Non-Randomised, Multicentre, Phase II Clinical Study of CP-4055 in Chemotherapy-Naïve Patients With Metastatic Malignant Melanoma
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 if they fulfil all inclusion- and exclusion criteria. 16 or 42
patients will be enrolled in Pittsburgh USA, Lund Sweden and Oslo Norway.
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A patient will continue treatment until complete response or until (s)he is withdrawn from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,
- 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)
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective tumour response
Svein Dueland, MD, Ph.D
The Norwegian Radium Hospital, Montebello, NO-0310 Oslo, Norway
Norway: Norwegian Medicines Agency
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