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

Phase 2
18 Years
Not Enrolling
Malignant Melanoma

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Trial Information

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

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.

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)

9. Presence of any significant central nervous system or psychiatric disorder(s) that
would hamper the patient's compliance

10. Pregnancy, breastfeeding or absence of adequate contraception for both male and
female fertile patients

11. Known positive status for HIV and/or hepatitis B or C

12. Drug and/or alcohol abuse

13. Any reason why, in the investigator's opinion, the patient should not participate

14. Prior treatment with CP-4055 and/or sorafenib

15. 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

16. Condition that impairs ability to swallow pills

17. Tendency of bleeding

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

• Objective tumour response

Outcome Time Frame:

October 2008

Safety Issue:


Principal Investigator

Svein Dueland, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Norwegian Radium Hospital, Oslo, Norway


Norway: Norwegian Medicines Agency

Study ID:




Start Date:

March 2007

Completion Date:

October 2008

Related Keywords:

  • Malignant Melanoma
  • CP-4055
  • Elacyt
  • Cancer
  • Metastatic
  • Malignant melanoma
  • Combination treatment
  • Sorafenib
  • Nexavar
  • Melanoma



University of Pittsburgh Cancer Institute Pittsburgh, Pennsylvania  15213
Cancer Therapy and Research Center, Institute for Drug Development San Antonio, Texas  78229