ABT-263 as single agent in women with platinum resistant/refractory recurrent ovarian cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
47
CHU Besançon - Hôpital Jean Minjoz
Besançon, France
Institut Bergonié
Bordeaux, France
Centre Francois Baclesse
Caen, France
The primary endpoint is the progression-free survival (PFS) in the whole cohort of patients with a recurrent platinum-resistant ovarian cancer.
Time frame: the time to progression (or death from any cause) from date of randomization until date of first documented progression or date of death from any cause,whichever came first, assessed up to 12 months. Evaluation at interim and final analyses.
Bim expression level
Bim expression level expressed by immunohistochemistry on biopsy of relapsing tumor at inclusion
Time frame: biopsy sample before initiation of treatment by ABT-263 and assessment within 6 months after end of inclusions
Response rate
\- Response rate defined by a complete response (CR), a partial response (PR) or a stable disease (SD) according to the RECIST v1.1
Time frame: evaluated every 6 weeks during treatment to progression or death for any cause.(during average 12 months)]
Overall survival (OS)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months.
Incidence of Treatment-Emergent Adverse Events according to the NCI CTC AE version 4.0
Toxicities
Time frame: From date of treatment start until end of study participation (during average 12 months)]
Peak Plasma Concentration of ABT-263
Time frame: 8-hour post-dose PK on D1 of C1 & 2. Dosage will be done within 12 months after end of inclusions
Residual concentration of ABT-263
Time frame: Pre-dose 0 and cycles 3, 4, 6 . Dosage will be done within 12 months after end of inclusions
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Centre Oscar Lambret
Lille, France
Centre Léon Bérard
Lyon, France
CHU
Lyon, France
ICM Val d'Aurelle
Montpellier, France
ICL Institut de Cancérologie de Lorraine
Nancy, France
Centre Catherine de Sienne
Nantes, France
ICO Centre René Gauducheau
Nantes, France
...and 6 more locations