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Advanced Colorectal CancerPhase 2NCT00498407

A Phase II Study of CP-4055 as Second Line Therapy in Patients With Advanced Colorectal Cancer

A Phase 2 study testing CP-4055 in people with Advanced Colorectal Cancer and Colorectal Cancer, run by Clavis Pharma at 4 sites in United Kingdom.

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 histologically or cytologically confirmed metastatic colorectal cancer (CRC) who have failed a first-line chemotherapeutic regimen containing oxaliplatin and 5-fluorouracil (5-FU) with or without bevacizumab, with or without other Investigational Medicinal Products (IMPs), will receive CP-4055 200… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Colorectal Cancer, Colorectal Cancer
What is being tested?
CP-4055
Type of treatment
Injection or infusion
How many people
16 participants
Where
4 sitesUnited Kingdom
Study dates
May 2007to Dec 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 histologically or cytologically confirmed metastatic CRC who have failed a first-line chemotherapeutic regimen containing oxaliplatin and 5-fluorouracil (5-FU) with or without bevacizumab, with or without other Investigational Medicinal Products (IMPs)
  • 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 (IC)
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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 CP-4055 treatment. Nursing patients are excluded.
  • 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
  • Radiotherapy to more than 30 % of bone marrow
  • Participation in another therapeutic clinical study within 30 days of enrolment or during this clinical study
  • Concomitant treatment with a non-permitted medication:
  • Alternative drugs
  • High doses of vitamins
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  • History of allergic reactions to ara-C or egg
  • Any serious concomitant systemic disorders incompatible with the clinical study (e.g. uncontrolled inter-current illness including ongoing or active infection)
  • 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

Trial locations and contacts

4 sites in 1 country.

United Kingdom4 sites

  • Aberdeen Royal Infirmary, Foresterhill,

    Aberdeen, AB25 2ZN

  • The Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN

  • Medical Oncology Dept. of Cancer Studies and Molecular Medicine, Leicester Royal Infirmary

    Leicester, LEI 5WW

  • Macmillan Lead Clinician in Gastro-intestinal Cancer Mount Vernon Cancer Centre

    Northwood, HA6 2RN

Other trials in United Kingdom

About this study

Patients with histologically or cytologically confirmed metastatic colorectal cancer (CRC) who have failed a first-line chemotherapeutic regimen containing oxaliplatin and 5-fluorouracil (5-FU) with or without bevacizumab, with or without other Investigational Medicinal Products (IMPs), will receive CP-4055 200 mg/m2/day intravenously (IV) on Day 1-5 every four weeks until complete response or disease worsening/progressing.

Read the detailed description

This is a multicentre clinical study conducted in the United Kingdom. It is an open label study designed to investigate objective response rate (RR), the time to progression (TTP) and the duration of tumor response in patients with colorectal cancer when treated with CP-4055. The quantitative and qualitative toxicities of the treatment will also be assessed.

Being tested
CP-4055
Keywords
CP-4055, ELACYT(TM), Cancer, Colorectal cancer, CRC, Second line therapy
Medical subject headings
Colorectal Neoplasms, Neoplasms

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 5 mg/mL for infusion, dose: 200 mg/m2/day, schedule: d1-5 q4, 30 minutes IV infusion

What is being measured

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

  1. • Objective response rate (RR)

    Measured: October 2008

Secondary outcomes (3)

  1. • Time to progression (TTP)

    Measured: October 2008

  2. • Duration of tumor response

    Measured: October 2008

  3. • Characterize the quantitative and the qualitative toxicities of the CP-4055 treatment in this patient population

    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 startMay 2007
  3. Primary completionDec 2008
  4. Study completionDec 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
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00498407
Sponsor's protocol ID
CP4055-202
Other IDs
Grantor: CDER, IND/IDE Number: NA
Status last verified
Jan 2009
First submitted
9 Jul 2007
Last updated
4 Jun 2009
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CP-4055 in people with Advanced Colorectal Cancer and Colorectal Cancer, run by Clavis Pharma at 4 sites in United Kingdom.

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 13 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 4 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United Kingdom. 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 response rate (RR) (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 NCT00498407.

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 4 Jun 2009.

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