A Study of ABT-263 as Single Agent in Women With Platinum Resistant/Refractory Recurrent Ovarian Cancer (MONAVI-1)

Centre Francois Baclesse

Status and phase

Completed

Phase 2

Conditions

Platinum-resistant or Refractory Ovarian Cancer

Treatments

Drug: ABT-263

Study type

Interventional

Funder types

Other

Identifiers

NCT02591095

2015-000193-35

Details and patient eligibility

About

ABT-263 as single agent in women with platinum resistant/refractory recurrent ovarian cancer.

Enrollment

47 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 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

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 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