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

Malignant Melanoma Clinical Trial

Official title:

A Multicentre, Dose Finding, Phase II Study of CP-4055 in Combination With Sorafenib in Patients With Metastatic Malignant Melanoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00498836
• Other study ID #: CP4055-203
• Status: Completed
• Phase: Phase 2
• First received: July 9, 2007
• Last updated: August 28, 2013
• Start date: March 2007
• Est. completion date: October 2008

Study information

• Verified date: August 2013
• Source: Clavis Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines AgencySweden: Medical Products AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malignant Melanoma
• Melanoma

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Norway	The Norwegian Radium Hospital	Oslo
Sweden	Lund University Hospital	Lund
Sweden	Umeå University Hospital	Umeå
Sweden	Uppsala University Hospital	Uppsala
United States	University of Pittsburgh Cancer Institute	Pittsburgh	Pennsylvania
United States	Cancer Therapy and Research Center, Institute for Drug Development	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Clavis Pharma

Countries where clinical trial is conducted

United States,  Norway,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• Objective tumour response		October 2008	No
Secondary	• Time to progression		October 2008	No
Secondary	• Duration of tumour response		October 2008	No
Secondary	• Safety and tolerability of treatment		October 2008	Yes