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Multicentre, Dose Finding, Ph II,CP-4055 in Comb. With Sorafenib - Patients With Metastatic Malignant Melanoma | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Multicentre, Dose Finding, Ph II,CP-4055 in Comb. With Sorafenib - Patients With Metastatic Malignant Melanoma

A Multicentre, Dose Finding, Phase II Study of CP-4055 in Combination With Sorafenib in Patients With Metastatic Malignant Melanoma

NCT00498836•Clavis Pharma

View on ClinicalTrials.gov

Summary

Patients with metastatic malignant melanoma will receive CP-4055 200 mg/m2/day intravenously (IV) on Day 1-5 every four weeks and sorafenib 400 mg b.i.d. (twice daily) every day until complete response or disease worsening/progressing.

Detailed Description

This is a multicentre clinical study conducted in the USA and in Europe. It is an open label study designed to investigate objective tumor response, the time to progression (TTP) and the duration of tumor response in patients with metastatic malignant melanoma when treated with CP-4055 in combination with sorafenib (Nexavar®). The safety and tolerability of the treatment will also be assessed.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients with histological or cytological confirmed stage IV or unresectable stage III non-ocular malignant melanoma who have or have not undergone prior chemotherapy for the treatment of melanoma
•2. Measurable disease according to Response Criteria In Solid Tumors (RECIST)
•3. Performance Status 0 - 1 according to ECOG (Eastern Cooperative Oncology Group) Performance Status
•4. Age 18 years or more
•5. Life expectancy \> 3 months
•6. Signed informed consent
•7. Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must have a negative serum or urine pregnancy test within 2 weeks prior to beginning treatment on this study
•8. Male and female patients must use acceptable contraceptive methods for the duration of time on study, and males also for 3 months after the last CP-4055 dose
•9. Adequate haematological and biological functions

Exclusion Criteria

•1. Known brain metastases
•2. Diagnosis of ocular malignant melanoma
•3. Radiotherapy to more than 30 % of bone marrow
•4. Participation in another therapeutic clinical study within 30 days of enrolment or during this clinical study
•5. Requirement of concomitant treatment with a non-permitted medication:
•* Alternative drugs
•* High doses of vitamins
•6. History of allergic reactions to ara-C or egg
•7. History of allergic reactions attributed to compounds of similar chemical or biological composition to sorafenib
•8. Presence of any serious concomitant systemic disorders incompatible with the clinical study (e.g. uncontrolled inter-current illness including ongoing or active infection)
+15 more criteria

Locations (6)

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, United States

Cancer Therapy and Research Center, Institute for Drug Development

San Antonio, Texas, United States

The Norwegian Radium Hospital

Oslo, Norway

Lund University Hospital

Lund, Sweden

Umeå University Hospital

Umeå, Sweden

Uppsala University Hospital

Uppsala, Sweden

Key Dates

Start Date

March 1, 2007

Primary Completion Date

October 1, 2008

Completion Date

October 1, 2008

Last Updated

September 12, 2013

Enrollment

ACTUAL participants

Conditions

Malignant Melanoma

Interventions

CP-4055

DRUG

Sorafenib (Nexavar)

DRUG

An Phase Ib/II Clinical Trial of TCC1727 Combination Therapy in Advanced Solid Tumors

NCT07371663

Solid CancersNSCLC (Advanced Non-small Cell Lung Cancer)+3 more

View study

RECRUITINGPHASE1/PHASE2

Modified Vaccine for High Risk or Low Residual Melanoma Patients

NCT01898039

Malignant Melanoma

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 12, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Multicentre, Dose Finding, Ph II,CP-4055 in Comb. With Sorafenib - Patients With Metastatic Malignant Melanoma

Inclusion Criteria

Exclusion Criteria

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