- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02591095
A Study of ABT-263 as Single Agent in Women With Platinum Resistant/Refractory Recurrent Ovarian Cancer (MONAVI-1)
March 15, 2019 updated by: Centre Francois Baclesse
ABT-263 as single agent in women with platinum resistant/refractory recurrent ovarian cancer.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
47
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Besançon, France
- CHU Besançon - Hôpital Jean Minjoz
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Bordeaux, France
- Institut Bergonie
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Caen, France
- Centre François Baclesse
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Lille, France
- Centre Oscar Lambret
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Lyon, France
- CHU
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Lyon, France
- Centre Leon Berard
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Montpellier, France
- ICM Val d'Aurelle
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Nancy, France
- ICL Institut de Cancérologie de Lorraine
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Nantes, France
- Centre Catherine De Sienne
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Nantes, France
- ICO Centre René Gauducheau
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Nantes, France
- ICO Paul Papin
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Nice, France
- Centre Antoine Lacassagne
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Paris, France
- Hopital Europeen Georges Pompidou
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Paris, France
- Hopital Tenon
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Toulouse, France
- Institut Claudius Regaud
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Villejuif, France
- Gustave Roussy
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: ABT-263
oral Navitoclax (ABT-263) daily
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
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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.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bim expression level
Time Frame: biopsy sample before initiation of treatment by ABT-263 and assessment within 6 months after end of inclusions
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Bim expression level expressed by immunohistochemistry on biopsy of relapsing tumor at inclusion
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biopsy sample before initiation of treatment by ABT-263 and assessment within 6 months after end of inclusions
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Response rate
Time Frame: evaluated every 6 weeks during treatment to progression or death for any cause.(during average 12 months)]
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- Response rate defined by a complete response (CR), a partial response (PR) or a stable disease (SD) according to the RECIST v1.1
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evaluated every 6 weeks during treatment to progression or death for any cause.(during average 12 months)]
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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.
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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.
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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)]
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Toxicities
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From date of treatment start until end of study participation (during average 12 months)]
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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
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8-hour post-dose PK on D1 of C1 & 2. Dosage will be done within 12 months after end of inclusions
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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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Pre-dose 0 and cycles 3, 4, 6 . Dosage will be done within 12 months after end of inclusions
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2016
Primary Completion (Actual)
April 1, 2017
Study Completion (Actual)
March 1, 2019
Study Registration Dates
First Submitted
October 14, 2015
First Submitted That Met QC Criteria
October 28, 2015
First Posted (Estimate)
October 29, 2015
Study Record Updates
Last Update Posted (Actual)
March 19, 2019
Last Update Submitted That Met QC Criteria
March 15, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
- Antineoplastic Agents
- Navitoclax
Other Study ID Numbers
- 2015-000193-35
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingRecurrent Fallopian Tube Carcinoma | Recurrent Ovarian Carcinoma | Recurrent Primary Peritoneal Carcinoma | Peritoneal Carcinomatosis | Malignant Peritoneal Neoplasm | Recurrent Endometrial Carcinoma | Stage IVB Uterine Corpus Cancer AJCC v8 | Recurrent Cervical Carcinoma | Metastatic Malignant Female... and other conditionsUnited States
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Vascular Biogenics Ltd. operating as VBL TherapeuticsCompletedPlatinum Resistant Ovarian CancerUnited States
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Shattuck Labs, Inc.Enrolling by invitationOvarian Cancer | Fallopian Tube Cancer | Epithelial Ovarian Cancer | Platinum-resistant Ovarian Cancer | Primary Peritoneal Carcinoma | Platinum-Resistant Fallopian Tube Carcinoma | Platinum-Resistant Primary Peritoneal CarcinomaUnited States, United Kingdom, Spain, Canada
Clinical Trials on ABT-263
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AbbVie (prior sponsor, Abbott)CompletedChronic Lymphocytic LeukemiaUnited States, Australia, Israel, Poland, Ukraine
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AbbottGenentech, Inc.CompletedHealthy Female SubjectsUnited States
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AbbVieTerminatedMyelofibrosis (MF)United States, Korea, Republic of, South Africa
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AbbVieGenentech, Inc.CompletedChronic Lymphocytic LeukemiaUnited States, Australia, Germany, United Kingdom
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AbbottGenentech, Inc.CompletedChronic Lymphocytic Leukemia | Lymphomas | LeukemiasUnited States
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AbbVie (prior sponsor, Abbott)CompletedFollicular Lymphoma | Non-Hodgkin's Lymphoma | Mantle Cell Lymphoma | Peripheral T-cell Lymphoma | Lymphoid Malignancies | Chronic Lymphoid LeukemiaUnited States, Canada