Clinical Study of Previously Untreated Patients With Malignant Melanoma
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Non-Randomised, Multicentre, Phase II Clinical Study of CP-4055 in Chemotherapy-Naïve Patients With Metastatic Malignant Melanoma|
- Objective tumour response
- Time to progression
- Duration of tumour response
- Safety and tolerability of treatment
|Study Start Date:||September 2005|
|Study Completion Date:||July 2007|
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A patient will continue treatment until complete response or until (s)he is withdrawn from the Clinical Study because of disease progression, unacceptable toxicity or any other reason described in the clinical study protocol.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, 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)
|United States, Pennsylvania|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15213-2584|
|The Norwegian Radium Hospital|
|Oslo, Norway, NO-0310|
|Lund, Sweden, SE-221 85|
|Principal Investigator:||Svein Dueland, MD, Ph.D||The Norwegian Radium Hospital, Montebello, NO-0310 Oslo, Norway|