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

Study Overview
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Brief Summary
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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

Detailed Description
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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

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

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Drug: CP-4055
* Drug: CP-4055


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open label CP-4055<br>Phase I: Dose escalation Phase II: Fixed dose | Drug: CP-4055<br>* D1-5 and D8(+2)-12(+2) q4w<br>Drug: CP-4055<br>* IV administration day 1-5 and day 8-12 in a 4 week schedule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase I: Determine recommended dose for phase II studies of CP-4055 when given five consecutive days twice in a 4 week schedule, D1-5 and D8(+2)-12(+2) q4w |  | August 2009/June 2010 | 
| Phase II: Determine the antitumour activity of CP-4055 |  | August 2009/June 2010 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine pharmacokinetic (PK) parameters |  | August 2009/June 2010 | 
| Explore the time to progression (TTP) |  | August 2009/June 2010 | 
| Investigate the duration of tumour response |  | August 2009/June 2010 | 
| Determine the nature and degree of toxicity of CP-4055 in this patient population |  | August 2009/June 2010 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CP-4055, Cancer, Metastatic, Solid tumors, advanced ovarian cancer, stage III and IV ovarian cancer, advanced epithelian ovarian cancer