Clinical Study of Previously Untreated Patients With 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: NCT00232726
Recruitment Status : Completed
First Posted : October 5, 2005
Last Update Posted : July 10, 2007
Information provided by:
Clavis Pharma

Brief Summary:
Previously untreated patients with malignant melanoma receive a new chemotherapy drug currently under development. CP-4055 is given intravenously on days 1-5 every four weeks until complete response or disease progression.

Condition or disease Intervention/treatment Phase
Malignant Melanoma Neoplasm Metastasis Drug: CP-4055 (ELACYT) Phase 2

Detailed Description:

This is an international multicentre phase II clinical study conducted in the USA and Europe. Previously untreated patients over 18 years, with metastatic malignant melanoma are eligible for inclusion if they fulfil all inclusion- and exclusion criteria. 16 or 42 patients will be enrolled in Pittsburgh USA, Lund Sweden and Oslo Norway.

The new development drug CP-4055 is administered for five consecutive days (Day 1 to 5) in a 4 week schedule (one cycle). The dose is 200 mg/m2/day.

A patient will continue treatment until complete response or until (s)he is withdrawn from the Clinical Study because of disease progression, unacceptable toxicity or any other reason described in the clinical study protocol.

Efficacy is assessed at baseline and end of every second cycle with CT or MRI.

Safety assessments are done at each visit. Blood samples are taken and haematological and biochemical parameters are assessed for safety.

Any adverse events are recorded and reported.

The clinical study has been approved by the relevant Independent Ethical Committees/Institutional Review Boards and Concerned Regulatory Authority as appropriate. It is conducted according to ICH Good Clinical Practice, the Declaration of Helsinki, and applicable national law and regulations.

Patients who give an additional consent will have two additional, and not mandatory, procedures performed:

  • Biopsy (tissue sample) from particular tumours (taken only at baseline for identification of tumour genes)
  • Serum samples (from blood drawn at baseline and at end of the cycle 2 for protein sequences analyses, proteomics)

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Non-Randomised, Multicentre, Phase II Clinical Study of CP-4055 in Chemotherapy-Naïve Patients With Metastatic Malignant Melanoma
Study Start Date : September 2005
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
U.S. FDA Resources

Primary Outcome Measures :
  1. Objective tumour response

Secondary Outcome Measures :
  1. Time to progression
  2. Duration of tumour response
  3. Safety and tolerability of treatment

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Patients with histologically or cytologically confirmed stage IV or unresectable stage III non-ocular malignant melanoma who have not undergone prior chemotherapy for the treatment of melanoma (chemotherapy-naïve)
  • Measurable disease according to Response Criteria in Solid Tumours (RECIST)
  • Performance Status 0 – 2 according to ECOG (Eastern Cooperative Oncology Group) Performance Status
  • Age 18 years or more
  • Life expectancy > 3 months
  • Signed informed consent
  • Adequate haematological and biological functions:

    • Bone marrow function:

      1. Neutrophils ≥ 1.5 x 10^9/L
      2. Platelets ≥ 100 x 10^9/L
      3. Hemoglobin (Hb) ≥ 10 g/dL
    • Hepatic function:

      1. AST/ALT ≤ 2.5 times institutional upper limit of normal (ULN). If liver metastases, ≤ 5 times institutional ULN.
      2. Serum bilirubin and alkaline phosphatase ≤ 1.5 times institutional ULN
    • Renal function:

      • Creatinine ≤ 1.5 times institutional ULN

Exclusion Criteria:

  • 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
  • Prior immunotherapy and/or chemotherapy for the treatment of melanoma
  • Requirement of concomitant treatment with a non-permitted medication:

    • Alternative drugs
    • High doses of vitamins
  • History of allergic reactions to Ara-C or egg
  • Presence of any serious concomitant systemic disorders incompatible with the clinical study (e.g. uncontrolled intercurrent 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

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): NCT00232726

United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213-2584
The Norwegian Radium Hospital
Oslo, Norway, NO-0310
University Hospital
Lund, Sweden, SE-221 85
Sponsors and Collaborators
Clavis Pharma
Principal Investigator: Svein Dueland, MD, Ph.D The Norwegian Radium Hospital, Montebello, NO-0310 Oslo, Norway

Additional Information: Identifier: NCT00232726     History of Changes
Other Study ID Numbers: CP4055-201
First Posted: October 5, 2005    Key Record Dates
Last Update Posted: July 10, 2007
Last Verified: July 2007

Keywords provided by Clavis Pharma:
Malignant melanoma
Chemotherapy-naïve patients
Phase II
Chemotherapy-naive patients
Metastatic malignant melanoma

Additional relevant MeSH terms:
Neoplasm Metastasis
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplastic Processes
Pathologic Processes