Platinum-resistant or refractory ovarian cancer MedDRA version: 18.0 Level: PT Classification code 10066697 Term: Ovarian cancer recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: NAVITOCLAX
Product Code: ABT-263
Pharmaceutical Form: Tablet
INN or Proposed INN: ABT-263
CAS Number: 923564-51-6
Current Sponsor code: ABT-263 (A-855071)
Other descriptive name: NAVITOC
Sponsors
Centre François Baclesse
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Woman older than 18 years -Subjects with Eastern Cooperative Oncology Group (ECOG) performance status = 2 -Histologically and/or cytologically documented high grade serous epithelial cancer of ovarian, fallopian tube or peritoneum -Platinum resistant ovarian cancer defined as relapsing within 6 months after a platinum based chemotherapy OR platinum refractory ovarian cancer defined as progressing during a platinum based chemotherapy (excepted primary resistant patients) -Subjects who are willing and able to comply with the protocol and study procedures including willingness to undergo tumor biopsy before therapy at screening -There is no limitation to prior number of therapies -Patients must have documented disease progression -Subjects who have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 46 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 46
Exclusion criteria
Exclusion criteria: -Patient’s refusal or impossibility to perform biopsy on relapsing disease -Bowel occlusive syndrome or other gastro-intestinal disorder that does not allow oral medication such as malabsorption -Patients with platinum primary resistant disease -Received radio-immunotherapy within 6 months of 1st dose of study drug -Received steroid therapy for anti-neoplastic intent within 7 days of the 1st dose of study drug (Inhaled steroids for asthma, topical steroids, replacement/stress corticosteroids, or corticosteroids taken as premedication are allowed) -Consumption of grapefruit or grapefruit products within 3 days prior to the first dose of study drug -Patient receiving treatments strong CYP3A4 inhibitors or inducers (Appendix A) -Positive for HIV -Predisposing condition/currently exhibiting signs of bleeding -Currently receiving anticoagulation therapy, exception of low-dose anticoagulation medications for prophylaxis -Received aspirin within 7 days of start dose of study drug -Active peptic ulcer disease / other potentially hemorrhagic esophagitis/gastritis -Active immune thrombocytopenic purpura, autoimmune hemolytic anemia or history of being refractory to platelet transfusions (within 1 year of 1st dose of study drug) -Uncontrolled cardiac, renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, or hepatic disease, active systemic fungal infection; diagnosis of fever and neutropenia within 1 week of study drug administration -A evidence of current/active malignancies other than ovarian cancer -Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine activity of ABT-263 for patients with a platinum resistant/refractory recurrent ovarian cancer;Secondary Objective: ? To determine activity of ABT-263 for patients with a high level of Bim expression determined by immunohistochemistry. ? To assess the overall survival in the whole cohort and in the two subgroups: with high or low Bim expression level ? To evaluate the objective response rate ? To evaluate the toxicity profile ? To evaluate the interest of FDG-PET scan as an indicator of the early response ? To explore the pharmacokinetics of ABT-263 ;Primary end point(s): The primary endpoint is the progression-free survival (PFS) in the whole cohort of patients with a recurrent platinum-resistant ovarian cancer. Progression-free survival is defined as the time to progression (or death from any cause) from ABT-263 treatment start, with censoring patients who have not progressed at the end of the study, on the date of last news. The progression is defined according to Recist Criteria. ;Timepoint(s) of evaluation of this end point: at disease progression (or death from any cause) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Bim expression level expressed by immunohistochemistry on biopsy of relapsing tumor at inclusion -Response rate defined by a complete response (CR), a partial response (PR) or a stable disease (SD) according to the RECIST v1.1 criteria. -Overall survival (OS), defined as time to death from treatment start, with censoring patients alive at the end of the study, on the date of last news. -Toxicities defined according to the NCI CTC AE version 4.0. -Pharmacokinetics of ABT-263 ;Timepoint(s) of evaluation of this end point: -Bim level determined by immunohistochemistry and expressed as low, medium or high. -Progression free survival (PFS), defined as time to progression (or death for any cause) from ABT-263 treatment start, with censoring patients who have not progressed at the end of the study, on the date of last news -Overall survival (OS), defined as time to death from treatment start,with censoring patients alive at the end of the study, on the date of last news. -Toxicities defined according to the NCI CTC AE version 4.0. -Pharmacokinetics of ABT-263 | — |
Countries
France
Contacts
Public ContactLECONTE
Centre François Baclesse
Outcome results
None listed