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

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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

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

Condition or disease Intervention/treatment Phase
Platinum-resistant or Refractory Ovarian Cancer Drug: ABT-263 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study of ABT-263 as Single Agent in Women With Platinum Resistant/Refractory Recurrent Ovarian Cancer
Actual Study Start Date : January 2016
Actual Primary Completion Date : April 2017
Actual Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arm Intervention/treatment
Experimental: ABT-263
oral Navitoclax (ABT-263) daily
Drug: ABT-263



Primary Outcome Measures :
  1. 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 Measures :
  1. 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

  2. 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

  3. 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. ]
  4. 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

  5. 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 ]
  6. 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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02591095


Locations
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France
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
Sponsors and Collaborators
Centre Francois Baclesse
ARCAGY/ GINECO GROUP
French Cancer Research Hospital Program

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Responsible Party: Centre Francois Baclesse
ClinicalTrials.gov Identifier: NCT02591095     History of Changes
Other Study ID Numbers: 2015-000193-35
First Posted: October 29, 2015    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Navitoclax
Antineoplastic Agents