Clinical Study of Previously Untreated Patients With Malignant Melanoma
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|ClinicalTrials.gov Identifier: NCT00232726|
Recruitment Status : Completed
First Posted : October 5, 2005
Last Update Posted : July 10, 2007
|Condition or disease||Intervention/treatment||Phase|
|Malignant Melanoma Neoplasm Metastasis||Drug: CP-4055 (ELACYT)||Phase 2|
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A patient will continue treatment until complete response or until (s)he is withdrawn from the Clinical Study because of disease progression, unacceptable toxicity or any other reason described in the clinical study protocol.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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Non-Randomised, Multicentre, Phase II Clinical Study of CP-4055 in Chemotherapy-Naïve Patients With Metastatic Malignant Melanoma|
|Study Start Date :||September 2005|
|Actual Study Completion Date :||July 2007|
- Objective tumour response
- Time to progression
- Duration of tumour response
- Safety and tolerability of treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00232726
|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|