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A Phase I/II Study of CP-4055 in Patients With Platinum Resistant Ovarian Cancer

Phase 1/Phase 2
18 Years
Not Enrolling
Ovarian Cancer

Thank you

Trial Information

A Phase I/II Study of CP-4055 in Patients With Platinum Resistant Ovarian Cancer

Phase I

- Three eligible patients will be enrolled at each dose level (DL), according to standard
dose escalation decision rules

- Patients will receive CP-4055 at increasing DLs until the maximum tolerated dose and
the recommended dose (RD) have been established

Phase II

- Step 1 (The patient inclusion may stop after this step):

- Patients will be enrolled at the RD until there are maximum 16 evaluable patients
at this DL

- Step 2:

- Depending on the response rate at step 1, up to 26 patients will be included and
treated at step 2

Inclusion Criteria:

- Histologically or cytologically documented advanced epithelial ovarian cancer
measurable with CT and/or MRI

- Received prior chemotherapy regimen(s) for ovarian cancer, at least one being a
platinum based therapy (PBT)

- Evidence of platinum resistant or refractory disease

- ECOG Performance Status 0 - 1

- Life expectancy > 3 months

- Signed informed consent (IC)

- Women of child-bearing potential must have a negative serum or urine pregnancy test.
Nursing patients are excluded.

- Women of child-bearing potential must not become pregnant while participating in the

- Adequate haematological and biological functions

Exclusion Criteria:

- Patients with mixed mullerian tumours (MMT) (carcinosarcomas)

- Known brain metastases

- Another known active cancer within the last 5 years

- 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

- A history of allergic reactions or sensitivity attributed to compounds of similar or
biological composition to CP-4055, i.e., ara-C and/or egg

- Any serious concomitant systemic disorders incompatible with the clinical study

- Any significant CNS or psychiatric disorder(s) that would hamper the patient's

- Pregnancy or breastfeeding

- 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

Type of Study:


Study Design:

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

Outcome Measure:

Phase I: Determine recommended dose for phase II studies of CP-4055 when given five consecutive days twice in a 4 week schedule, D1-5 and D8(+2)-12(+2) q4w

Outcome Time Frame:

August 2009/June 2010

Safety Issue:


Principal Investigator

Sandro Pignata, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical Oncology B, National Cancer Institute, Via Mariano Semmola, IT-80131 Naples, Italy


United States: Food and Drug Administration

Study ID:




Start Date:

April 2008

Completion Date:

April 2010

Related Keywords:

  • Ovarian Cancer
  • CP-4055
  • Cancer
  • Metastatic
  • Solid tumors
  • advanced ovarian cancer
  • stage III and IV ovarian cancer
  • advanced epithelian ovarian cancer
  • Ovarian Neoplasms