NCT00232726

CompletedPhase 2

Clinical Study of Previously Untreated Patients With Maligna...

Clavis Pharma Source

Clavis Pharma

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

CP4055-201

Study Type

interventional

Estimated enrollment

42

Locations

3 countries

Sites

3

Timeline

Study Start

September 2005

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

July 2007

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Estimated enrollment: 42 participants
Study completion date: July 2007
Actual (reported)
Listed locations: 3 countries · 3 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
September 2005
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
October 4, 2005
Actual (reported)
First Posted
October 5, 2005
Actual (reported)
Study Completion
July 2007
Actual (reported)

Last Updated: July 10, 2007
Status Verified: July 2007
Last Update Submitted: July 9, 2007

Conditions

Malignant Melanoma Neoplasm 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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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)

Sponsors & Collaborators

Clavis Pharma
Industrylead

Study Sites (3)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213-2584, United States

The Norwegian Radium Hospital

Oslo, NO-0310, Norway

University Hospital

Lund, SE-221 85, Sweden

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 Diseases

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 2005

Date type not reported

This date has not been verified as actual or estimated.

Study Completion

July 2007

Actual (reported)

NCT00001685

Immunization of HLA-A201 Patients With Metastatic Melanoma Using a Combination of Immunodominant Peptides From Three Melanoma Antigens, MART-1, GP100 and Tyrosinase

Phase 2Completed

NCT00001832

Lymphocyte Re-infusion During Immune Suppression to Treat Metastatic Melanoma

Phase 2Completed

NCT00001705

Immunization of Patients With Metastatic Melanoma Using the GP100 Peptide Preceded by an Endoplasmic Reticulum Insertion Signal Sequence

Phase 2Completed

NCT02452294

Buparlisib in Melanoma Patients Suffering From Brain Metastases (BUMPER)

Phase 2Unknown

NCT00107718

Anti-Tumor Activity Of SB-485232 In Patients With Previously Untreated Metastatic Melanoma

Phase 2Completed

NCT00289627

A Single Arm Study of Ipilimumab Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma

Phase 2Completed

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.

Neoplastic Processes

Pathologic Processes

Pathological Conditions, Signs and Symptoms

Last Updated

July 10, 2007

Record last verified: 2007-07

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00232726
Data provider: ClinicalTrials.gov
Source updated: 2007-07-10
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:27:21 UTC

Locations

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

Clinical Study of Previously Untreated Patients With Malignant Melanoma

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations