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

Sponsor

Clavis Pharma (Industry)

Overall Status

Completed

CT.gov ID

NCT00498836

Collaborator

(none)

Enrollment

Locations

19.1

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

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 :

Mar 1, 2007

Actual Primary Completion Date :

Oct 1, 2008

Actual Study Completion Date :

Oct 1, 2008

Outcome Measures

Primary Outcome Measures

• Objective tumour response [October 2008]

Secondary Outcome Measures

• Time to progression [October 2008]
• Duration of tumour response [October 2008]
• Safety and tolerability of treatment [October 2008]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pittsburgh Cancer Institute	Pittsburgh	Pennsylvania	United States	15232
2	Cancer Therapy and Research Center, Institute for Drug Development	San Antonio	Texas	United States	78229
3	The Norwegian Radium Hospital	Oslo		Norway	NO-0310
4	Lund University Hospital	Lund		Sweden	SE-221 85
5	Umeå University Hospital	Umeå		Sweden
6	Uppsala University Hospital	Uppsala		Sweden	SE-751 85