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

September 5, 2023 updated by: ARCAGY/ GINECO GROUP

Phase 2 Multicenter Study to Assess the Safety and Efficacy of BKM120 as Monotherapy in Treatment of Initial or Recurrent Metastatic Endometrial Cancer After 1st Line Therapy in Patients Who Cannot Undergo Local Surgery and/or Radiotherapy

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Ales, France
        • Clinique Bonnefon
      • Angers, France
        • Centre Paul Papin
      • Avignon, France
        • Institut Ste Catherine
      • Besancon, France
        • Hopital Jean Minjoz
      • Blois, France
        • Centre Hospitalier de Blois
      • Bordeaux, France
        • Institut Bergonié
      • Bordeaux, France
        • Clinique Tivoli
      • Bordeaux, France
        • Polyclinique Bordeaux Nord
      • Caen, France
        • Centre François Baclesse
      • Clermont Ferrand, France
        • Centre Jean Perrin
      • Colmar, France
        • Hôpitaux Civils de Colmar
      • Dijon, France
        • Centre Georges François Leclerc
      • Grenoble, France
        • Group Hospitalier Mutualiste de Grenoble
      • Grenoble, France
        • Hôpital Michallon - CHU Grenoble
      • Le Chesnay, France
        • Hopital Andre Mignot
      • Le Mans, France
        • Centre Jean Bernard
      • Lille, France
        • Centre Oscar Lambret
      • Limoges, France
        • Chu Dupuytren
      • Lyon, France
        • Centre léon bérard
      • Marseille, France
        • Institut Paoli Calmette
      • Marseille, France
        • Hôpital Prové Clairval
      • Montpellier, France, 34298
        • CRLC Val d'Aurelle
      • Montpellier, France
        • Groupement de coopération sanitaire
      • Nancy, France
        • Centre Alexis Vautrin
      • Nancy, France
        • Centre d'oncologie de Gentilly
      • Nantes, France
        • Centre Catherine de Sienne
      • Nice, France
        • Centre Antoine Lacassagne
      • Nimes, France
        • CHU Caremeau
      • Nimes, France
        • Clinique Valdegour
      • Orléans, France
        • Centre Hospitalier Regional
      • Paris, France, 75020
        • Hopital Tenon
      • Paris, France, 75004
        • Hôpital Hôtel Dieu
      • Rennes, France
        • Centre Eugène Marquis
      • Rouen, France
        • Centre Henri Becquerel
      • Rouen, France
        • Centre Frédéric JOLIOT
      • Saint Brieuc, France
        • Clinique Armoricaine de Radiologie
      • St Cloud, France
        • Hopital René Huguenin
      • St Herblain, France
        • Ico Rene Gauducheau
      • St Nazaire, France
        • Centre Etienne DOLET
      • St Priest en Jarez, France
        • Institut cancérologuie de la loire
      • Strasbourg, France
        • Hôpital Civil
      • Toulouse, France, 31052
        • Centre Claudius Regaud
      • Tours, France
        • Chu Bretonneau
      • Villejuif, France
        • Institut Gustave Roussy
      • la Roche sur Yon, France
        • CHD Les Oudairies

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Female ≥ 18 years
  • 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:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: stratum 1
Patients with low grade disease (grade 1 or 2) with positive or negative mutational status
Drug: BKM120
per os, 60mg/j, until progression or unacceptable toxicity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Efficacy
Time Frame: 3 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety according to CTCAE v4.0 criteria and mood questionnaires : PHQ-9 and GAD-7
Time Frame: Patient will be followed for the duration of the study, an expected average of 75 days
To assess patient safety and the tolerance of BKM120 administered as monotherapy at the daily dose of 100 mg.
Patient will be followed for the duration of the study, an expected average of 75 days
Efficacy: PFS
Time Frame: 6 months
To evaluate progression-free survival
6 months
Efficacy: ORR
Time Frame: Patient will be followed for the duration of the study, an expected average of 75 days
To evaluate the objective response rate according to RECIST 1.1
Patient will be followed for the duration of the study, an expected average of 75 days
Efficacy: overall survival
Time Frame: Patients will be followed for an expected average of 1 year and 75 days
To evaluate overall survival.
Patients will be followed for an expected average of 1 year and 75 days
Efficacy: duration of response
Time Frame: Patients will be followed for an expected average of 1 year and 75 days

To evaluate the duration of the response. For patients in complete remission, the duration of the response will be calculated from the day on which a complete response is determined for the first time up to progression.

For patients in partial remission, the duration of the response will be the overall response period calculated from the administration of the first treatment cycle up to the date of progression.
Patients will be followed for an expected average of 1 year and 75 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ARCAGY/ GINECO GROUP

Investigators

  • Principal Investigator: Isabelle Ray-Coquard, MD, GINECO - Centre Léon Bérard

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

July 18, 2011

First Submitted That Met QC Criteria

July 19, 2011

First Posted (Estimated)

July 20, 2011

Study Record Updates

Last Update Posted (Actual)

September 6, 2023

Last Update Submitted That Met QC Criteria

September 5, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENDOPIK

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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