NCT00232726

Brief Summary

Previously untreated patients with malignant melanoma receive a new chemotherapy drug currently under development. CP-4055 is given intravenously on days 1-5 every four weeks until complete response or disease progression.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2005

Geographic Reach
3 countries

3 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

September 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 4, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 5, 2005

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

July 10, 2007

Status Verified

July 1, 2007

First QC Date

October 4, 2005

Last Update Submit

July 9, 2007

Conditions

Malignant MelanomaNeoplasm Metastasis

Keywords

Malignant melanomaCP-4055Chemotherapy-naïve patientsPhase IIChemotherapy-naive patientsMetastatic malignant melanoma

Outcome Measures

Primary Outcomes (1)

  • Objective tumour response

Secondary Outcomes (3)

  • Time to progression

  • Duration of tumour response

  • Safety and tolerability of treatment

Interventions

CP-4055 (ELACYT)DRUG

Eligibility Criteria

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

You may qualify if:

  • Patients with histologically or cytologically confirmed stage IV or unresectable stage III non-ocular malignant melanoma who have not undergone prior chemotherapy for the treatment of melanoma (chemotherapy-naïve)
  • Measurable disease according to Response Criteria in Solid Tumours (RECIST)
  • Performance Status 0 - 2 according to ECOG (Eastern Cooperative Oncology Group) Performance Status
  • Age 18 years or more
  • Life expectancy \> 3 months
  • Signed informed consent
  • Adequate haematological and biological functions:
  • Bone marrow function:
  • Neutrophils ≥ 1.5 x 10\^9/L
  • Platelets ≥ 100 x 10\^9/L
  • Hemoglobin (Hb) ≥ 10 g/dL
  • Hepatic function:
  • AST/ALT ≤ 2.5 times institutional upper limit of normal (ULN). If liver metastases, ≤ 5 times institutional ULN.
  • Serum bilirubin and alkaline phosphatase ≤ 1.5 times institutional ULN
  • Renal function:
  • +1 more criteria

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
  • Prior immunotherapy and/or chemotherapy for the treatment of melanoma
  • Requirement of concomitant treatment with a non-permitted medication:
  • Alternative drugs
  • High doses of vitamins
  • History of allergic reactions to Ara-C or egg
  • Presence of any serious concomitant systemic disorders incompatible with the clinical study (e.g. uncontrolled intercurrent 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213-2584, United States

Location

The Norwegian Radium Hospital

Oslo, NO-0310, Norway

Location

University Hospital

Lund, SE-221 85, Sweden

Location

Related Links

MeSH Terms

Conditions

MelanomaNeoplasm Metastasis

Interventions

5'-oleoyl cytarabine

Condition Hierarchy (Ancestors)

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

Study Officials

  • Svein Dueland, MD, Ph.D

    The Norwegian Radium Hospital, Montebello, NO-0310 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

Study Record Dates

First Submitted

October 4, 2005

First Posted

October 5, 2005

Study Start

September 1, 2005

Study Completion

July 1, 2007

Last Updated

July 10, 2007

Record last verified: 2007-07

Locations

US(1)NO(1)SE(1)