Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00232726
Status:
COMPLETED
Last Update Posted:
2007-07-10
First Post:
2005-10-04
Brief Title:
Clinical Study of Previously Untreated Patients With Malignant Melanoma
Sponsor:
Clavis Pharma
Organization:
Clavis Pharma
Study Overview
Official Title:
A Non-Randomised Multicentre Phase II Clinical Study of CP-4055 in Chemotherapy-Naïve Patients With Metastatic Malignant Melanoma
Status:
COMPLETED
Status Verified Date:
2007-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 mgm2day
A patient will continue treatment until complete response or until she is withdrawn from the Clinical Study because of disease progression unacceptable toxicity or any other reason described in the clinical study protocol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 CommitteesInstitutional 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
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 mgm2day
A patient will continue treatment until complete response or until she 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 CommitteesInstitutional 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None