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

Phase 2
18 Years
Not Enrolling
Advanced Colorectal Cancer, Colorectal Cancer

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Trial Information

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

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

Inclusion Criteria:

1. 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)

2. Measurable disease according to Response Criteria In Solid Tumours (RECIST)

3. Performance Status 0 - 2 according to ECOG (Eastern Cooperative Oncology Group)
Performance Status

4. Age 18 years or more

5. Life expectancy > 3 months

6. Signed informed consent (IC)

7. 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.

8. 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

9. Adequate haematological and biological functions

Exclusion Criteria:

1. Known brain metastases

2. Radiotherapy to more than 30 % of bone marrow

3. Participation in another therapeutic clinical study within 30 days of enrolment or
during this clinical study

4. Concomitant treatment with a non-permitted medication:

- Alternative drugs

- High doses of vitamins

5. History of allergic reactions to ara-C or egg

6. Any serious concomitant systemic disorders incompatible with the clinical study (e.g.
uncontrolled inter-current illness including ongoing or active infection)

7. Any significant central nervous system or psychiatric disorder(s) that would hamper
the patient's compliance

8. Pregnancy, breastfeeding or absence of adequate contraception for both male and
female fertile patients

9. Known positive status for HIV and/or hepatitis B or C

10. Drug and/or alcohol abuse

11. Any reason why, in the investigator's opinion, the patient should not participate

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

• Objective response rate (RR)

Outcome Time Frame:

October 2008

Safety Issue:


Principal Investigator

Jim Cassidy, MBChB, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Beatson West of Scotland Cancer Centre


United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:




Start Date:

May 2007

Completion Date:

December 2008

Related Keywords:

  • Advanced Colorectal Cancer
  • Colorectal Cancer
  • CP-4055
  • Cancer
  • Colorectal cancer
  • CRC
  • Second line therapy
  • Colorectal Neoplasms