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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00498836
Recruitment Status : Completed
First Posted : July 10, 2007
Last Update Posted : September 12, 2013
Information provided by (Responsible Party):
Clavis Pharma

July 9, 2007
July 10, 2007
September 12, 2013
March 2007
October 2008   (Final data collection date for primary outcome measure)
• Objective tumour response [ Time Frame: October 2008 ]
• Objective tumour response
Complete list of historical versions of study NCT00498836 on Archive Site
  • • Time to progression [ Time Frame: October 2008 ]
  • • Duration of tumour response [ Time Frame: October 2008 ]
  • • Safety and tolerability of treatment [ Time Frame: October 2008 ]
  • • Time to progression
  • • Duration of tumour response
  • • Safety and tolerability of treatment
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Not Provided
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
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.
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.
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Malignant Melanoma
  • Drug: CP-4055
    CP-4055 5mg/mL for infusion, dose: 200 mg/m2/day, schedule d1-5 q4w, 30 minutes IV infusion
    Other Name: ELACYT (TM)
  • Drug: Sorafenib (Nexavar)
    Sorafenib 200 mg tablets, dose: 400 mg/day, daily dosing
    Other Name: Nexavar
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
October 2008
October 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Norway,   Sweden,   United States
Not Provided
Not Provided
Clavis Pharma
Clavis Pharma
Not Provided
Principal Investigator: Svein Dueland, MD The Norwegian Radium Hospital, Oslo, Norway
Clavis Pharma
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP