NCT00498836

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2007

Geographic Reach
3 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 10, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

September 12, 2013

Status Verified

August 1, 2013

Enrollment Period

1.6 years

First QC Date

July 9, 2007

Last Update Submit

August 28, 2013

Conditions

Malignant Melanoma

Keywords

CP-4055ElacytCancerMetastaticMalignant melanomaCombination treatmentSorafenibNexavar

Outcome Measures

Primary Outcomes (1)

  • • Objective tumour response

    October 2008

Secondary Outcomes (3)

  • • Time to progression

    October 2008

  • • Duration of tumour response

    October 2008

  • • Safety and tolerability of treatment

    October 2008

Interventions

CP-4055DRUG

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

Also known as: ELACYT (TM)
Sorafenib (Nexavar)DRUG

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

Also known as: Nexavar

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15232, United States

Location

Cancer Therapy and Research Center, Institute for Drug Development

San Antonio, Texas, 78229, United States

Location

The Norwegian Radium Hospital

Oslo, NO-0310, Norway

Location

Lund University Hospital

Lund, SE-221 85, Sweden

Location

Umeå University Hospital

Umeå, Sweden

Location

Uppsala University Hospital

Uppsala, SE-751 85, Sweden

Location

MeSH Terms

Conditions

MelanomaNeoplasmsNeoplasm Metastasis

Interventions

5'-oleoyl cytarabineSorafenib

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylurea CompoundsUreaAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNiacinamideNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Svein Dueland, MD

    The Norwegian Radium Hospital, Oslo, Norway

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2007

First Posted

July 10, 2007

Study Start

March 1, 2007

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

September 12, 2013

Record last verified: 2013-08

Locations

SE(3)NO(1)US(2)