A Phase 2 interventional study of CP-4055 (ELACYT) in Malignant Melanoma and Neoplasm Metastasis, sponsored by Clavis Pharma. Completed at 3 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-07-10.
Sponsored by Clavis Pharma · Phase 2, Interventional, and Treatment
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.
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A patient will continue treatment until complete response or until (s)he is withdrawn from the Clinical Study because of disease progression, unacceptable toxicity or any other reason described in the clinical study protocol.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:
3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.
This study's planned enrollment of 42 is above the median of 38 across 2,351 interventional studies indexed under Melanoma.
Browse Melanoma studies →Clavis Pharma is the lead sponsor of 11 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adequate haematological and biological functions:
Bone marrow function:
Hepatic function:
Renal function:
Exclusion Criteria:
Requirement of concomitant treatment with a non-permitted medication:
Objective tumour response
Time to progression
Duration of tumour response
Safety and tolerability of treatment
This study is completed, as verified in Jul 2007. You cannot join it, but the record below documents what was studied.
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Clavis Pharma