Status:
COMPLETED
A Phase I/II Study of CP-4055 in Patients With Platinum Resistant Ovarian Cancer
Lead Sponsor:
Clavis Pharma
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 ...
Detailed 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 to...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00831636
Start Date
April 1 2008
End Date
April 1 2010
Last Update
September 13 2013
Active Locations (5)
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1
U.Z. Gasthuisberg, Gynecologic Oncology, Herestraat 49
Leuven, Belgium, B-3000
2
Medical Oncology C, National Cancer Institute, Centro di Riferimento Oncologico
Aviano (PN), Italy
3
Medical Oncology B, National Cancer Institute, Via Mariano Semmola
Naples, Italy, IT-80131
4
Department of Oncology, Catholic University of the Sacred Heart
Rome, Italy, 00168