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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02591095
• Date of registration: 14/10/2015
• Prospective Registration: Yes
• Primary sponsor: Centre Francois Baclesse
• Public title: A Study of ABT-263 as Single Agent in Women With Platinum Resistant/Refractory Recurrent Ovarian Cancer MONAVI-1
• Scientific title: A Study of ABT-263 as Single Agent in Women With Platinum Resistant/Refractory Recurrent Ovarian Cancer
• Date of first enrolment: January 2016
• Target sample size: 47
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02591095
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

France

Key inclusion & exclusion 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 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Platinum-resistant or Refractory Ovarian Cancer

Intervention(s)

Drug: ABT-263

Primary Outcome(s)

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.]

Secondary Outcome(s)

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]

Bim expression level [Time Frame: biopsy sample before initiation of treatment by ABT-263 and assessment within 6 months after end of inclusions]

Incidence of Treatment-Emergent Adverse Events according to the NCI CTC AE version 4.0 [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]

Response rate [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.]

Secondary ID(s)

2015-000193-35

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

ARCAGY/ GINECO GROUP

French Cancer Research Hospital Program