GINECO-EN102b - BKM120 as Monotherapy in the Treatment of Initial or Recurrent Metastatic Endometrial Cancer

NCT01397877 | Completed Phase 2 DMC

• 1 other identifier: ENDOPIK
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 45

Brief Summary

This study is to determine the clinical efficacy of BKM120 as monotherapy in the treatment of initial or recurrent metastatic endometrial cancer after first line radio chemotherapy. 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

Conditions

Endometrial Cancer

Keywords

endometrial cancer; BKM; monotherapy; metastatic; initial treatment

Outcome Measures

Primary Outcomes (1)

• Clinical Efficacy

  To determine the clinical efficacy of BKM120 as monotherapy in the treatment of initial or recurrent metastatic endometrial cancer after first line radio chemotherapy.

  3 months

Secondary Outcomes (5)

• Safety according to CTCAE v4.0 criteria and mood questionnaires : PHQ-9 and GAD-7

  Patient will be followed for the duration of the study, an expected average of 75 days

• Efficacy: PFS

  6 months

• Efficacy: ORR

  Patient will be followed for the duration of the study, an expected average of 75 days

• Efficacy: overall survival

  Patients will be followed for an expected average of 1 year and 75 days

• Efficacy: duration of response

  Patients will be followed for an expected average of 1 year and 75 days

Study Arms (1)

stratum 1

EXPERIMENTAL

Patients with low grade disease (grade 1 or 2) with positive or negative mutational status

Drug: BKM120

Interventions

BKM120 DRUG

per os, 60mg/j, until progression or unacceptable toxicity

stratum 1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female ≥ 18 years
• ECOG ≤ 2
• Histologically confirmed endometrial cancer
• Not eligible for exclusive curative treatment by surgery and/or radiotherapy
• 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
• 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

You may not qualify if:

• Previous treatment with PI3K inhibitors and/or mTOR
• 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
• 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
• 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

Sponsors & Collaborators

• ARCAGY/ GINECO GROUP: lead

Study Sites (45)

Clinique Bonnefon

Alès, France

Location

Centre Paul Papin

Angers, France

Location

Institut Ste Catherine

Avignon, France

Location

Hôpital jean Minjoz

Besançon, France

Location

Centre Hospitalier de Blois

Blois, France

Location

Clinique Tivoli

Bordeaux, France

Location

Institut Bergonié

Bordeaux, France

Location

Polyclinique Bordeaux Nord

Bordeaux, France

Location

centre Francois baclesse

Caen, France

Location

Centre jean Perrin

Clermont-Ferrand, France

Location

Hôpitaux Civils de Colmar

Colmar, France

Location

Centre Georges François leclerc

Dijon, France

Location

Group Hospitalier Mutualiste de Grenoble

Grenoble, France

Location

Hôpital Michallon - CHU Grenoble

Grenoble, France

Location

CHD Les Oudairies

La Roche-sur-Yon, France

Location

Hôpital André Mignot

Le Chesnay, France

Location

Centre jean Bernard

Le Mans, France

Location

Centre Oscar Lambret

Lille, France

Location

CHU Dupuytren

Limoges, France

Location

Centre Léon bérard

Lyon, France

Location

Hôpital Prové Clairval

Marseille, France

Location

institut Paoli Calmette

Marseille, France

Location

CRLC Val d'Aurelle

Montpellier, 34298, France

Location

Groupement de coopération sanitaire

Montpellier, France

Location

Centre Alexis Vautrin

Nancy, France

Location

Centre d'oncologie de Gentilly

Nancy, France

Location

Centre Catherine de Sienne

Nantes, France

Location

Centre Antoine Lacassagne

Nice, France

Location

CHU Caremeau

Nîmes, France

Location

Clinique Valdegour

Nîmes, France

Location

Centre Hospitalier Régional

Orléans, France

Location

Hopital Hotel Dieu

Paris, 75004, France

Location

Hopital Tenon

Paris, 75020, France

Location

Centre Eugene Marquis

Rennes, France

Location

Centre Frederic Joliot

Rouen, France

Location

Centre Henri Becquerel

Rouen, France

Location

Clinique Armoricaine de Radiologie

Saint-Brieuc, France

Location

Hôpital rené Huguenin

Saint-Cloud, France

Location

ICO René Gauducheau

Saint-Herblain, France

Location

Centre Etienne DOLET

Saint-Nazaire, France

Location

Institut cancérologuie de la loire

Saint-Priest-en-Jarez, France

Location

Hôpital Civil

Strasbourg, France

Location

Centre Claudius Régaud

Toulouse, 31052, France

Location

CHU Bretonneau

Tours, France

Location

Institut Gustave Roussy

Villejuif, France

Location

MeSH Terms

Conditions

Endometrial Neoplasms; Neoplasm Metastasis

Interventions

NVP-BKM120

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Isabelle Ray-Coquard, MD

  GINECO - Centre Léon Bérard

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2011
• First Posted: July 20, 2011
• Study Start: December 1, 2011
• Primary Completion: October 1, 2014
• Study Completion: March 1, 2016
• Last Updated: September 6, 2023

Record last verified: 2023-09

Locations

FR (45)