Multicentre, Dose Finding, Ph II,CP-4055 in Comb. With Sorafenib - Patients With Metastatic Malignant Melanoma
NCT ID: NCT00498836
Last Updated: 2013-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
18 participants
INTERVENTIONAL
2007-03-31
2008-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CP-4055
CP-4055 5mg/mL for infusion, dose: 200 mg/m2/day, schedule d1-5 q4w, 30 minutes IV infusion
Sorafenib (Nexavar)
Sorafenib 200 mg tablets, dose: 400 mg/day, daily dosing
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Clavis Pharma
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Svein Dueland, MD
Role: PRINCIPAL_INVESTIGATOR
The Norwegian Radium Hospital, Oslo, Norway
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States
Cancer Therapy and Research Center, Institute for Drug Development
San Antonio, Texas, United States
The Norwegian Radium Hospital
Oslo, , Norway
Lund University Hospital
Lund, , Sweden
Umeå University Hospital
Umeå, , Sweden
Uppsala University Hospital
Uppsala, , Sweden
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CP4055-203
Identifier Type: -
Identifier Source: org_study_id