A Phase I/II Study of CP-4055 in Patients With Platinum Resistant Ovarian Cancer
NCT ID: NCT00831636
Last Updated: 2013-09-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
28 participants
INTERVENTIONAL
2008-04-30
2010-04-30
Brief Summary
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Detailed Description
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* 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
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Open label CP-4055
Phase I: Dose escalation Phase II: Fixed dose
CP-4055
D1-5 and D8(+2)-12(+2) q4w
CP-4055
IV administration day 1-5 and day 8-12 in a 4 week schedule
Interventions
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CP-4055
D1-5 and D8(+2)-12(+2) q4w
CP-4055
IV administration day 1-5 and day 8-12 in a 4 week schedule
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Clavis Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Sandro Pignata, MD
Role: PRINCIPAL_INVESTIGATOR
Medical Oncology B, National Cancer Institute, Via Mariano Semmola, IT-80131 Naples, Italy
Locations
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U.Z. Gasthuisberg, Gynecologic Oncology, Herestraat 49
Leuven, , Belgium
Medical Oncology C, National Cancer Institute, Centro di Riferimento Oncologico
Aviano (PN), , Italy
Medical Oncology B, National Cancer Institute, Via Mariano Semmola
Naples, , Italy
Department of Oncology, Catholic University of the Sacred Heart
Rome, , Italy
Medical Oncology, Fatebenefratelli Hospital, Isola Tiberina
Rome, , Italy
Countries
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Related Links
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Clavis Pharma Home Page
Other Identifiers
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CP4055-204
Identifier Type: -
Identifier Source: org_study_id