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Platinum-resistant or Refractory Ovarian CancerPhase 2MONAVI-1NCT02591095

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

A Phase 2 study testing ABT-263 in people with Platinum-resistant or Refractory Ovarian Cancer, run by Centre Francois Baclesse at 16 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

ABT-263 as single agent in women with platinum resistant/refractory recurrent ovarian cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
ABT-263
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
16 sitesFrance
Study dates
Jan 2016to Mar 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • - 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

France16 sites

  • CHU Besançon - Hôpital Jean Minjoz

    Besançon

  • Institut Bergonié

    Bordeaux

  • Centre Francois Baclesse

    Caen

  • Centre Oscar Lambret

    Lille

  • Centre Léon Bérard

    Lyon

  • CHU

    Lyon

  • ICM Val d'Aurelle

    Montpellier

  • ICL Institut de Cancérologie de Lorraine

    Nancy

  • Centre Catherine de Sienne

    Nantes

  • ICO Centre René Gauducheau

    Nantes

  • ICO Paul Papin

    Nantes

  • Centre Antoine LACASSAGNE

    Nice

  • Hôpital Européen Georges Pompidou

    Paris

  • Hôpital Tenon

    Paris

  • Institut Claudius Regaud

    Toulouse

  • Gustave Roussy

    Villejuif

Other trials in France

About this study

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

Being tested
ABT-263
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABT-263Drug

Study groups in NCT02591095
Study groupRoleWhat they receive
ABT-263Experimentaloral Navitoclax (ABT-263) daily
Receives: Drug: ABT-263

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary endpoint is the progression-free survival (PFS) in the whole cohort of patients with a recurrent platinum-resistant ovarian cancer.

    Measured: 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 outcomes (6)

  1. Bim expression level

    Bim expression level expressed by immunohistochemistry on biopsy of relapsing tumor at inclusion

    Measured: biopsy sample before initiation of treatment by ABT-263 and assessment within 6 months after end of inclusions

  2. Response rate

    • Response rate defined by a complete response (CR), a partial response (PR) or a stable disease (SD) according to the RECIST v1.1

    Measured: evaluated every 6 weeks during treatment to progression or death for any cause.(during average 12 months)]

  3. Overall survival (OS)

    Measured: 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

    Toxicities

    Measured: From date of treatment start until end of study participation (during average 12 months)]

  5. Peak Plasma Concentration of ABT-263

    Measured: 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

    Measured: Pre-dose 0 and cycles 3, 4, 6 . Dosage will be done within 12 months after end of inclusions

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2015 (estimated)
  2. Study startJan 2016
  3. Primary completionApr 2017
  4. Study completionMar 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02591095
Sponsor's protocol ID
2015-000193-35
Other IDs
2015
Acronym
MONAVI-1
Status last verified
Mar 2019
First submitted
14 Oct 2015
Last updated
19 Mar 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Joly F, Fabbro M, Follana P, Lequesne J, Medioni J, Lesoin A, Frenel JS, Abadie-Lacourtoisie S, Floquet A, Gladieff L, You B, Gavoille C, Kalbacher E, Briand M, Brachet PE, Giffard F, Weiswald LB, Just PA, Blanc-Fournier C, Leconte A, Clarisse B, Leary A, Poulain L. A phase II study of Navitoclax (ABT-263) as single agent in women heavily pretreated for recurrent epithelial ovarian cancer: The MONAVI - GINECO study. Gynecol Oncol. 2022 Apr;165(1):30-39. doi: 10.1016/j.ygyno.2022.01.021. Epub 2022 Feb 2.

    PubMed 35123771

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ABT-263 in people with Platinum-resistant or Refractory Ovarian Cancer, run by Centre Francois Baclesse at 16 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02591095, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2019.

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