GINECO-EN102b - BKM120 as Monotherapy in the Treatment of Initial or Recurrent Metastatic Endometrial Cancer
NCT ID: NCT01397877
Last Updated: 2023-09-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
24 participants
INTERVENTIONAL
2011-12-31
2016-03-31
Brief Summary
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Clinical efficacy will be determined by the non-progression rate at 3 or 2 months depending on the group of patients. The primary endpoint is the non-progression rate at 3 months (12 weeks) for the patient group whose disease is painless (low grade tumor = stratum 1) and the non-progression rate at 2 months (8 weeks) for the group of patients with an aggressive disease (high grade tumor = stratum 2).
Disease progression is defined by the RECIST 1.1 criteria
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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stratum 1
Patients with low grade disease (grade 1 or 2) with positive or negative mutational status
BKM120
per os, 60mg/j, until progression or unacceptable toxicity
Interventions
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BKM120
per os, 60mg/j, until progression or unacceptable toxicity
Eligibility Criteria
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Inclusion Criteria
* ECOG ≤ 2
* Histologically confirmed endometrial cancer
* Not eligible for exclusive curative treatment by surgery and/or radiotherapy
* Initial metastatic endometrial cancer not treated with chemotherapy or radiotherapy prior to inclusion OR
* Recurrent endometrial cancer previously treated with adjuvant CT and RT, presenting with a disease-free interval of at least 12 months
* Presence of one or more measurable lesion(s) outside the irradiated areas
* Availability at inclusion of samples of tumor tissue (a block or at least 20 unstained slides) for tumor sub-classification and for routine molecular analysis
* Satisfactory biological functions: PNN ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, hemoglobin ≥ 9.0 g/dL, INR ≤ 2, standard normal values for potassium, calcium and magnesium, serum creatinine ≤ 1.5 x ULN or creatinine clearance \> 50 mL/min, ALT and AST within normal range (or ≤ 3.0 x ULN if liver metastases present), Alkaline phosphatase ≤ 2.5 x ULN, serum bilirubin within normal range (or ≤ 1.5 x ULN if liver metastases present; or total bilirubin ≤ 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert Syndrome), fasting glycemia ≤ 120 mg/dL or ≤ 6.7 mmol/L
* Life expectancy 3 months
* Post menopausal woman with at least 12 months of natural (spontaneous) amenorrhea
* Negative serum pregnancy test ≤ 72 hours prior to initiating treatment for woman of child-bearing potential
* Consent form signed before any procedure performed
Exclusion Criteria
* Presence of symptomatic CNS metastases. Patient must have completed any prior treatment for CNS metastases ≥ 28 days and, if on corticosteroid therapy, should be receiving a stable low dose
* Concomitant presence or history of another malignant tumor in the past 3 years prior to inclusion (except spinocellular or cutaneous basal cell epithelioma or non-melanomatous skin cancer treated successfully)
* Suffering from mood disorders based on an evaluation by the investigator or a psychiatrist OR with a given score according to the PHQ-9 or GAD-7 mood evaluation scale (cf protocol)
* Concomitant administration of another approved or investigational anticancer agent
* Pelvic and/or para-aortic radiotherapy within ≤ 28 days prior to inclusion or persistent side effects from this treatment on implementation of the selection procedures
* Major surgery during the 28 days prior to starting investigational drug or persistent side effects from surgery
* Uncontrolled diabetes (HbA1c \> 8 %)
* Presence of an active heart disease, especially: LVEF \< 50 % determined by MUGA or ECHO, QTc \> 480 msec on ECG recorded during selection (with QTcF formula), angina warranting the administration of anti-angina treatment, ventricular arrhythmia except for benign premature ventricular contractions, supraventricular and nodal arrhythmias warranting a pacemaker or not controlled by a treatment, conduction anomalies warranting a pacemaker, valvular disease with documented involvement of cardiac function, symptomatic pericarditis
* History of heart disease
* Currently receiving treatment to prolong QT interval accompanied by a known risk of triggering wave burst arrhythmia. Impossible to stop treatment or to replace it before starting study medication
* GI dysfunction or disease that could significantly interfere with absorption of BKM120
* Chronic treatment with corticosteroids or other immunosuppressants
* Any other severe and/or uncontrolled concomitant disease, which is likely to contraindicate the patient's participation
* Known treatment non-compliance
* Currently receiving treatment known to be inhibitors or moderate and strong inducers of isoenzyme CYP3A. Impossible to stop this treatment or to replace it with a different treatment before starting the study product
* Severe pneumonitis
* Grade ≥ 3 biological anomalies
* Known history of HIV infection
* Pregnant woman or nursing mother
18 Years
FEMALE
No
Sponsors
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ARCAGY/ GINECO GROUP
OTHER
Responsible Party
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Principal Investigators
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Isabelle Ray-Coquard, MD
Role: PRINCIPAL_INVESTIGATOR
GINECO - Centre Léon Bérard
Locations
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Clinique Bonnefon
Alès, , France
Centre Paul Papin
Angers, , France
Institut Ste Catherine
Avignon, , France
Hôpital jean Minjoz
Besançon, , France
Centre Hospitalier de Blois
Blois, , France
Clinique Tivoli
Bordeaux, , France
Institut Bergonié
Bordeaux, , France
Polyclinique Bordeaux Nord
Bordeaux, , France
centre Francois baclesse
Caen, , France
Centre jean Perrin
Clermont-Ferrand, , France
Hôpitaux Civils de Colmar
Colmar, , France
Centre Georges François leclerc
Dijon, , France
Group Hospitalier Mutualiste de Grenoble
Grenoble, , France
Hôpital Michallon - CHU Grenoble
Grenoble, , France
CHD Les Oudairies
La Roche-sur-Yon, , France
Hôpital André Mignot
Le Chesnay, , France
Centre jean Bernard
Le Mans, , France
Centre Oscar Lambret
Lille, , France
CHU Dupuytren
Limoges, , France
Centre Léon bérard
Lyon, , France
Hôpital Prové Clairval
Marseille, , France
institut Paoli Calmette
Marseille, , France
CRLC Val d'Aurelle
Montpellier, , France
Groupement de coopération sanitaire
Montpellier, , France
Centre Alexis Vautrin
Nancy, , France
Centre d'oncologie de Gentilly
Nancy, , France
Centre Catherine de Sienne
Nantes, , France
Centre Antoine Lacassagne
Nice, , France
CHU Caremeau
Nîmes, , France
Clinique Valdegour
Nîmes, , France
Centre Hospitalier Régional
Orléans, , France
Hopital Hotel Dieu
Paris, , France
Hopital Tenon
Paris, , France
Centre Eugene Marquis
Rennes, , France
Centre Frederic Joliot
Rouen, , France
Centre Henri Becquerel
Rouen, , France
Clinique Armoricaine de Radiologie
Saint-Brieuc, , France
Hôpital rené Huguenin
Saint-Cloud, , France
ICO René Gauducheau
Saint-Herblain, , France
Centre Etienne DOLET
Saint-Nazaire, , France
Institut cancérologuie de la loire
Saint-Priest-en-Jarez, , France
Hôpital Civil
Strasbourg, , France
Centre Claudius Régaud
Toulouse, , France
CHU Bretonneau
Tours, , France
Institut Gustave Roussy
Villejuif, , France
Countries
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Other Identifiers
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ENDOPIK
Identifier Type: -
Identifier Source: org_study_id
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