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

NCT00498836 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2013-09-12

No results posted yet for this study

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.

Conditions

  • Malignant Melanoma

Interventions

DRUG

CP-4055

CP-4055 5mg/mL for infusion, dose: 200 mg/m2/day, schedule d1-5 q4w, 30 minutes IV infusion

DRUG

Sorafenib (Nexavar)

Sorafenib 200 mg tablets, dose: 400 mg/day, daily dosing

Sponsors & Collaborators

  • Clavis Pharma

    lead INDUSTRY

Principal Investigators

  • Svein Dueland, MD · The Norwegian Radium Hospital, Oslo, Norway

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2008-10-31
Completion
2008-10-31

Countries

  • United States
  • Norway
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00498836 on ClinicalTrials.gov