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

Brief 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.

Condition or disease Intervention/treatment Phase
Malignant Melanoma Drug: CP-4055 Drug: Sorafenib (Nexavar) Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicentre, Dose Finding, Phase II Study of CP-4055 in Combination With Sorafenib in Patients With Metastatic Malignant Melanoma
Study Start Date : March 2007
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Intervention Details:
  • 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

Primary Outcome Measures :
  1. • Objective tumour response [ Time Frame: October 2008 ]

Secondary Outcome Measures :
  1. • Time to progression [ Time Frame: October 2008 ]
  2. • Duration of tumour response [ Time Frame: October 2008 ]
  3. • Safety and tolerability of treatment [ Time Frame: October 2008 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00498836

United States, Pennsylvania
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15232
United States, Texas
Cancer Therapy and Research Center, Institute for Drug Development
San Antonio, Texas, United States, 78229
The Norwegian Radium Hospital
Oslo, Norway, NO-0310
Lund University Hospital
Lund, Sweden, SE-221 85
Umeå University Hospital
Umeå, Sweden
Uppsala University Hospital
Uppsala, Sweden, SE-751 85
Sponsors and Collaborators
Clavis Pharma
Principal Investigator: Svein Dueland, MD The Norwegian Radium Hospital, Oslo, Norway

Responsible Party: Clavis Pharma Identifier: NCT00498836     History of Changes
Other Study ID Numbers: CP4055-203
First Posted: July 10, 2007    Key Record Dates
Last Update Posted: September 12, 2013
Last Verified: August 2013

Keywords provided by Clavis Pharma:
Malignant melanoma
Combination treatment

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors