A Study of ABT-263 as Single Agent in Women With Platinum Resistant/Refractory Recurrent Ovarian Cancer
NCT ID: NCT02591095
Last Updated: 2019-03-19
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
47 participants
INTERVENTIONAL
2016-01-31
2019-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ABT-263
oral Navitoclax (ABT-263) daily
ABT-263
Interventions
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ABT-263
Eligibility Criteria
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Inclusion Criteria
* 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 refractory patients in first line)
* Subjects having received at least 2 prior lines of treatments including platinum regimen
* 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
* Adequate bone marrow, renal and hepatic function per local laboratory reference range as follows:• Absolute Neutrophil Count ≥ 1500/ mm3
* Platelets ≥ 150,000 / mm3
* Hemoglobin ≥ 9.0 g/dL
* Renal function: Serum creatinine ≤1.2mg/dL or calculated creatinine clearance ≥ 60mL/min
* AST/ALT ≤ 3.0× the upper limit of normal (ULN); \[Subjects with liver metastasis may have AST, ALP, and ALT less then or equal to 5.0 X ULN\]
* Bilirubin ≤ 1.25×ULN
* Coagulation: aPTT and PT not to exceed 1.2 × ULN
* LVEF \> 50% by echocardiograms or MUGA
* Patients must give written informed consent
Exclusion Criteria
* Bowel occlusive syndrome or other gastro-intestinal disorder that does not allow oral medication such as malabsorption
* Patients with platinum refractory disease in first line
* 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 and VHC
* 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
18 Years
FEMALE
No
Sponsors
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ARCAGY/ GINECO GROUP
OTHER
French Cancer Research Hospital Program
UNKNOWN
Centre Francois Baclesse
OTHER
Responsible Party
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Locations
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CHU Besançon - Hôpital Jean Minjoz
Besançon, , France
Institut Bergonié
Bordeaux, , France
Centre Francois Baclesse
Caen, , France
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
ICO Paul Papin
Nantes, , France
Centre Antoine LACASSAGNE
Nice, , France
Hôpital Européen Georges Pompidou
Paris, , France
Hôpital Tenon
Paris, , France
Institut Claudius Regaud
Toulouse, , France
Gustave Roussy
Villejuif, , France
Countries
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References
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Joly F, Fabbro M, Follana P, Lequesne J, Medioni J, Lesoin A, Frenel JS, Abadie-Lacourtoisie S, Floquet A, Gladieff L, You B, Gavoille C, Kalbacher E, Briand M, Brachet PE, Giffard F, Weiswald LB, Just PA, Blanc-Fournier C, Leconte A, Clarisse B, Leary A, Poulain L. A phase II study of Navitoclax (ABT-263) as single agent in women heavily pretreated for recurrent epithelial ovarian cancer: The MONAVI - GINECO study. Gynecol Oncol. 2022 Apr;165(1):30-39. doi: 10.1016/j.ygyno.2022.01.021. Epub 2022 Feb 2.
Other Identifiers
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2015-000193-35
Identifier Type: -
Identifier Source: org_study_id
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