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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02591095
Recruitment Status : Completed
First Posted : October 29, 2015
Last Update Posted : March 19, 2019
Sponsor:
Collaborators:
ARCAGY/ GINECO GROUP
French Cancer Research Hospital Program
Information provided by (Responsible Party):
Centre Francois Baclesse

Tracking Information
First Submitted Date  ICMJE October 14, 2015
First Posted Date  ICMJE October 29, 2015
Last Update Posted Date March 19, 2019
Actual Study Start Date  ICMJE January 2016
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 28, 2015)
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. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02591095 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2015)
  • Bim expression level [ Time Frame: biopsy sample before initiation of treatment by ABT-263 and assessment within 6 months after end of inclusions ]
    Bim expression level expressed by immunohistochemistry on biopsy of relapsing tumor at inclusion
  • Response rate [ Time Frame: evaluated every 6 weeks during treatment to progression or death for any cause.(during average 12 months)] ]
    - Response rate defined by a complete response (CR), a partial response (PR) or a stable disease (SD) according to the RECIST v1.1
  • 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. ]
  • 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)] ]
    Toxicities
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of ABT-263 as Single Agent in Women With Platinum Resistant/Refractory Recurrent Ovarian Cancer
Official Title  ICMJE A Study of ABT-263 as Single Agent in Women With Platinum Resistant/Refractory Recurrent Ovarian Cancer
Brief Summary ABT-263 as single agent in women with platinum resistant/refractory recurrent ovarian cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Platinum-resistant or Refractory Ovarian Cancer
Intervention  ICMJE Drug: ABT-263
Study Arms  ICMJE Experimental: ABT-263
oral Navitoclax (ABT-263) daily
Intervention: Drug: ABT-263
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 15, 2019)
47
Original Estimated Enrollment  ICMJE
 (submitted: October 28, 2015)
46
Actual Study Completion Date  ICMJE March 2019
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02591095
Other Study ID Numbers  ICMJE 2015-000193-35
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre Francois Baclesse
Study Sponsor  ICMJE Centre Francois Baclesse
Collaborators  ICMJE
  • ARCAGY/ GINECO GROUP
  • French Cancer Research Hospital Program
Investigators  ICMJE Not Provided
PRS Account Centre Francois Baclesse
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP