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Malignant MelanomaPhase 2NCT00498836

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

A Phase 2 study testing CP-4055 and Sorafenib (Nexavar) in people with Malignant Melanoma, run by Clavis Pharma at 6 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Malignant Melanoma
What is being tested?
CP-4055 and Sorafenib (Nexavar)
How many people
18 participants
Where
6 sitesin 3 countries
Study dates
Mar 2007to Oct 2008
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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
  • Prior treatment with CP-4055 and/or sorafenib
  • 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
  • Condition that impairs ability to swallow pills
  • Tendency of bleeding

Trial locations and contacts

6 sites in 3 countries.

6 sites in 3 countries

Sweden3 sites

  • Lund University Hospital

    Lund, SE-221 85

  • Umeå University Hospital

    Umeå

  • Uppsala University Hospital

    Uppsala, SE-751 85

Other trials in Sweden

United States2 sites

  • University of Pittsburgh Cancer Institute

    Pittsburgh, Pennsylvania, 15232

  • Cancer Therapy and Research Center, Institute for Drug Development

    San Antonio, Texas, 78229

Other trials in United States

Norway1 site

  • The Norwegian Radium Hospital

    Oslo, NO-0310

Other trials in Norway

About this study

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

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.

Read the detailed 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.

Being tested
CP-4055, Sorafenib (Nexavar)
Keywords
CP-4055, Elacyt, Cancer, Metastatic, Malignant melanoma, Combination treatment, Sorafenib, Nexavar
Medical subject headings
Melanoma, Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CP-4055Drug

    Also called ELACYT (TM)

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

  • Sorafenib (Nexavar)Drug

    Also called Nexavar

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. • Objective tumour response

    Measured: October 2008

Secondary outcomes (3)

  1. • Time to progression

    Measured: October 2008

  2. • Duration of tumour response

    Measured: October 2008

  3. • Safety and tolerability of treatment

    Measured: October 2008

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2007 (estimated)
  2. Study startMar 2007
  3. Primary completionOct 2008
  4. Study completionOct 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00498836
Sponsor's protocol ID
CP4055-203
Status last verified
Aug 2013
First submitted
9 Jul 2007
Last updated
12 Sep 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CP-4055 and Sorafenib (Nexavar) in people with Malignant Melanoma, run by Clavis Pharma at 6 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Sweden, United States, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

• Objective tumour response (time frame: October 2008). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00498836.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2013.

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