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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Clavis Pharma
ClinicalTrials.gov Identifier:
NCT00498836
First received: July 9, 2007
Last updated: August 28, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Malignant Melanoma
Drug: CP-4055
Drug: Sorafenib (Nexavar)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Clavis Pharma:

Primary Outcome Measures:
  • • Objective tumour response [ Time Frame: October 2008 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • • Time to progression [ Time Frame: October 2008 ] [ Designated as safety issue: No ]
  • • Duration of tumour response [ Time Frame: October 2008 ] [ Designated as safety issue: No ]
  • • Safety and tolerability of treatment [ Time Frame: October 2008 ] [ Designated as safety issue: Yes ]

Enrollment: 18
Study Start Date: March 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
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
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00498836

Locations
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
Norway
The Norwegian Radium Hospital
Oslo, Norway, NO-0310
Sweden
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
Investigators
Principal Investigator: Svein Dueland, MD The Norwegian Radium Hospital, Oslo, Norway
  More Information

No publications provided

Responsible Party: Clavis Pharma
ClinicalTrials.gov Identifier: NCT00498836     History of Changes
Other Study ID Numbers: CP4055-203
Study First Received: July 9, 2007
Last Updated: August 28, 2013
Health Authority: Norway: Norwegian Medicines Agency
Sweden: Medical Products Agency
United States: Food and Drug Administration

Keywords provided by Clavis Pharma:
CP-4055
Elacyt
Cancer
Metastatic
Malignant melanoma
Combination treatment
Sorafenib
Nexavar

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Sorafenib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014