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

Clavis Pharma

Status and phase

Completed

Phase 2

Phase 1

Conditions

Ovarian Cancer

Treatments

Drug: CP-4055

Study type

Interventional

Funder types

Industry

Identifiers

NCT00831636

CP4055-204

Details and patient eligibility

About

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

Full description

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

Enrollment

28 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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