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

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

This is non randomised, open label, dose finding, efficacy and safety study, enrolling patients with advanced (stage III and IV) ovarian cancer It will be conducted in two successive phases. Phase II has a two-step design

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