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Clinical Trial 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.

Clinical Trial 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 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A patient will continue treatment until complete response or until (s)he is withdrawn from the Clinical Study because of disease progression, unacceptable toxicity or any other reason described in the clinical study protocol.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) ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

NCT number NCT00232726
Study type Interventional
Source Clavis Pharma
Status Completed
Phase Phase 2
Start date September 2005
Completion date July 2007

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