CT-2106 for the Second Line Treatment of Ovarian Cancer
NCT ID: NCT00291837
Last Updated: 2010-02-26
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
PHASE2
40 participants
INTERVENTIONAL
2004-11-30
2007-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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CT-2106
Eligibility Criteria
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Inclusion Criteria
* Only one prior chemotherapy containing either cisplatin or carboplatin plus taxanes administered concomitantly
* At least one measurable lesion according to RECIST
* ECOG performance status 0 or 1
* at least 18 years old
* Adequate haematological function
* Adequate renal and hepatic functions
* Normal coagulation parameters
Exclusion Criteria
* Pregnant or lactating patients
* Prior treatment with camptothecins
* Presence or history of CNS metastasis or carcinomatous leptomeningitis;
* Current active infection per investigator assessment;
* Unresolved bowel obstruction or subobstruction, uncontrolled Crohn's disease or ulcerative colitis;
* Current history of chronic diarrhea \>= grade 1 (CTCAE version 3);
* Surgery or radiotherapy ≤ 4 weeks before first study treatment. In case of cytoreductive surgery for the progression of the disease, ≤ 2 weeks before the 1st study treatment are allowed;
* Other uncontrolled, serious illness or medical condition, as determined by the investigator;
* Concomitant (or within 4 weeks before inclusion) administration of any other experimental drug under investigation;
* Concurrent treatment with any other anti-cancer therapy;
* Known HIV positivity or AIDS-related illness;
* Patients who cannot be regularly followed up for psychological, social, familial or geographic reasons.
18 Years
FEMALE
No
Sponsors
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CTI BioPharma
INDUSTRY
Principal Investigators
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Hilary Calvert, PhD
Role: PRINCIPAL_INVESTIGATOR
Newcastle General Hospital
Locations
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Lyon, , France
Saint-Brieuc, , France
Campobasso, , Italy
Birmingham, , United Kingdom
London, , United Kingdom
Newcastle upon Tyne, , United Kingdom
Surrey, , United Kingdom
Countries
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Other Identifiers
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CAM203
Identifier Type: -
Identifier Source: org_study_id