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

August 28, 2013 updated by: Clavis Pharma

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.

Study Overview

Status

Completed

Conditions

Malignant Melanoma

Intervention / Treatment

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

Enrollment (Actual)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Norway
- - Oslo, Norway, NO-0310
    - The Norwegian Radium Hospital
Sweden
- - Lund, Sweden, SE-221 85
    - Lund University Hospital
  - Umeå, Sweden
    - Umeå University Hospital
  - Uppsala, Sweden, SE-751 85
    - Uppsala University Hospital
United States
- Pennsylvania
  - Pittsburgh, Pennsylvania, United States, 15232
    - University of Pittsburgh Cancer Institute
- Texas
  - San Antonio, Texas, United States, 78229
    - Cancer Therapy and Research Center, Institute for Drug Development

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

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
Measurable disease according to Response Criteria In Solid Tumors (RECIST)
Performance Status 0 - 1 according to ECOG (Eastern Cooperative Oncology Group) Performance Status
Age 18 years or more
Life expectancy > 3 months
Signed informed consent
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
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
Adequate haematological and biological functions

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
Requirement of concomitant treatment with a non-permitted medication:
- Alternative drugs
- High doses of vitamins
History of allergic reactions to ara-C or egg
History of allergic reactions attributed to compounds of similar chemical or biological composition to sorafenib
Presence of any serious concomitant systemic disorders incompatible with the clinical study (e.g. uncontrolled inter-current 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
Prior treatment with CP-4055 and/or sorafenib
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
Condition that impairs ability to swallow pills
Tendency of bleeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
• Objective tumour response Time Frame: October 2008	October 2008

Secondary Outcome Measures

Outcome Measure	Time Frame
• Time to progression Time Frame: October 2008	October 2008
• Duration of tumour response Time Frame: October 2008	October 2008
• Safety and tolerability of treatment Time Frame: October 2008	October 2008

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clavis Pharma

Investigators

Principal Investigator: Svein Dueland, MD, The Norwegian Radium Hospital, Oslo, Norway

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)