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

Completed · Phase 2

Conditions studied: Malignant Melanoma

In brief

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.

Key facts

Study ID

NCT00498836

Run by

Clavis Pharma

People needed

18

Starts

2007-03-01

Expected to finish

2008-10-01

Last updated by the study team

2013-09-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Measurable disease according to Response Criteria In Solid Tumors (RECIST)
• Performance Status 0 - 1 according to ECOG (Eastern Cooperative Oncology Group) Performance Status
• Age 18 years or more
• Life expectancy > 3 months
• Signed informed consent
• 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
• 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
• Adequate haematological and biological functions

You may not qualify if…

• Known brain metastases
• Diagnosis of ocular malignant melanoma
• Radiotherapy to more than 30 % of bone marrow
• Participation in another therapeutic clinical study within 30 days of enrolment or during this clinical study
• Requirement of concomitant treatment with a non-permitted medication:
• Alternative drugs
• High doses of vitamins
• History of allergic reactions to ara-C or egg
• History of allergic reactions attributed to compounds of similar chemical or biological composition to sorafenib
• Presence of any serious concomitant systemic disorders incompatible with the clinical study (e.g. uncontrolled inter-current illness including ongoing or active infection)
• Presence of any significant central nervous system or psychiatric disorder(s) that would hamper the patient's compliance
• Pregnancy, breastfeeding or absence of adequate contraception for both male and female fertile patients
• Known positive status for HIV and/or hepatitis B or C
• Drug and/or alcohol abuse
• Any reason why, in the investigator's opinion, the patient should not participate
• Prior treatment with CP-4055 and/or sorafenib
• Significant history of cardiac disease, including any of the following:
• Uncontrolled hypertension
• Unstable angina pectoris
• Congestive heart failure
• Myocardial infarction within the past 6 months
• Unstable ventricular arrhythmia
• Other cardiac arrhythmia
• Condition that impairs ability to swallow pills
• Tendency of bleeding

Where it is running

• 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

Full record on ClinicalTrials.gov

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