A Phase I/II Study of CP-4055 in Patients with Platinum Resistant Ovarian Cancer - CP4055-204

Conditions: A phase I/II clinical study of CP4055 in patients with platinum resistant ovarian cancer

Registration Number: EUCTR2007-003323-20-BE

Lead Sponsor: Clavis Pharma ASA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 50

Inclusion Criteria

1. Histologically or cytologically documented advanced (stage III and IV according to the FIGO and AJCC systems) epithelial ovarian cancer measurable with CT and/or MRI, excluding mixed mullerian tumours (MMT) (carcinosarcomas)
2. Received prior chemotherapy regimen(s) for ovarian cancer, at least one being a platinum based therapy (PBT); i.e., carboplatin, cisplatin, or another organoplatinum compound. The last dose of prior chemotherapy should have been given at least 6 weeks before start of CP-4055 treatment
3. Evidence of platinum resistant or refractory disease. Resistant defined as progression according to RECIST or CA-125 within 6 months after completion of PBT. Refractory defined as progression during PBT or no disease free period during PBT. See Appendix B1 and Appendix B2
4. ECOG Performance Status 0 – 1
5. Age 18 years or more
6. Life expectancy > 3 months
7. Signed informed consent (IC)
8. 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 beginning treatment on this study. Nursing patients are excluded.
9. Women of child-bearing potential must not become pregnant while participating in the study
10. Adequate haematological and biological functions:
• Bone marrow function:
a.Neutrophils = 1.5 x 10 in 9 /L
b.Platelets = 100 x 10 in 9 /L
c.Hb = 9 g/dL
• Hepatic function:
a.AST (SGOT) / ALT (SGPT) = 2.5 times institutional upper limit of normal (ULN). If liver metastases = 5 times institutional ULN
b.Serum bilirubin = 1.5 times institutional ULN
• Renal function:
Creatinine = 1.5 times institutional ULN

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patients with mixed mullerian tumours (MMT) (carcinosarcomas)
2. Known brain metastases
3. Another known active cancer within the last 5 years
4. Radiotherapy to more than 30 % of bone marrow
5. Participation in another therapeutic clinical study within 30 days of enrolment or during this clinical study
6. Concomitant treatment with a non-permitted medication:
• Alternative medicine, i.e., any of various systems of healing or treating disease (such as non-prescriptive drugs, herbal medicine, homeopathy)
• High doses of vitamins
7. 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
8. Any serious concomitant systemic disorders incompatible with the clinical study (e.g. uncontrolled inter-current illness including ongoing or active infection)
9. Any significant central nervous system or psychiatric disorder(s) that would hamper the patient’s compliance
10. Pregnancy or breastfeeding
11. Known positive status for HIV and/or hepatitis B or C
12. Drug and/or alcohol abuse
13. Any reason why, in the investigator’s opinion, the patient should not participate