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 study
• 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 compliance
• 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