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Endometrial CancerPhase 2ENDOPIKNCT01397877

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

A Phase 2 study testing BKM120 in people with Endometrial Cancer, run by ARCAGY/ GINECO GROUP at 45 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

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Endometrial Cancer
What is being tested?
BKM120
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
45 sitesFrance
Study dates
Dec 2011to Mar 2016
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

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

45 sites in 1 country.

45 sites in 1 country

France45 sites

  • Clinique Bonnefon

    Alès

  • Centre Paul Papin

    Angers

  • Institut Ste Catherine

    Avignon

  • Hôpital jean Minjoz

    Besançon

  • Centre Hospitalier de Blois

    Blois

  • Clinique Tivoli

    Bordeaux

  • Institut Bergonié

    Bordeaux

  • Polyclinique Bordeaux Nord

    Bordeaux

  • centre Francois baclesse

    Caen

  • Centre jean Perrin

    Clermont-Ferrand

  • Hôpitaux Civils de Colmar

    Colmar

  • Centre Georges François leclerc

    Dijon

  • Group Hospitalier Mutualiste de Grenoble

    Grenoble

  • Hôpital Michallon - CHU Grenoble

    Grenoble

  • CHD Les Oudairies

    La Roche-sur-Yon

  • Hôpital André Mignot

    Le Chesnay

  • Centre jean Bernard

    Le Mans

  • Centre Oscar Lambret

    Lille

  • CHU Dupuytren

    Limoges

  • Centre Léon bérard

    Lyon

  • Hôpital Prové Clairval

    Marseille

  • institut Paoli Calmette

    Marseille

  • CRLC Val d'Aurelle

    Montpellier, 34298

  • Groupement de coopération sanitaire

    Montpellier

  • Centre Alexis Vautrin

    Nancy

  • Centre d'oncologie de Gentilly

    Nancy

  • Centre Catherine de Sienne

    Nantes

  • Centre Antoine Lacassagne

    Nice

  • CHU Caremeau

    Nîmes

  • Clinique Valdegour

    Nîmes

  • Centre Hospitalier Régional

    Orléans

  • Hopital Hotel Dieu

    Paris, 75004

  • Hopital Tenon

    Paris, 75020

  • Centre Eugene Marquis

    Rennes

  • Centre Frederic Joliot

    Rouen

  • Centre Henri Becquerel

    Rouen

  • Clinique Armoricaine de Radiologie

    Saint-Brieuc

  • Hôpital rené Huguenin

    Saint-Cloud

  • ICO René Gauducheau

    Saint-Herblain

  • Centre Etienne DOLET

    Saint-Nazaire

  • Institut cancérologuie de la loire

    Saint-Priest-en-Jarez

  • Hôpital Civil

    Strasbourg

  • Centre Claudius Régaud

    Toulouse, 31052

  • CHU Bretonneau

    Tours

  • Institut Gustave Roussy

    Villejuif

Other trials in France

About this study

Official title: 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

Being tested
BKM120
Keywords
endometrial cancer, BKM, monotherapy, metastatic, initial treatment
Medical subject headings
Endometrial Neoplasms, Neoplasm Metastasis

What participants receive

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

  • BKM120Drug

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

Study groups in NCT01397877
Study groupRoleWhat they receive
stratum 1ExperimentalPatients with low grade disease (grade 1 or 2) with positive or negative mutational status
Receives: Drug: BKM120

What is being measured

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

  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.

    Measured: 3 months

Secondary outcomes (5)

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

    To assess patient safety and the tolerance of BKM120 administered as monotherapy at the daily dose of 100 mg.

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

  2. Efficacy: PFS

    To evaluate progression-free survival

    Measured: 6 months

  3. Efficacy: ORR

    To evaluate the objective response rate according to RECIST 1.1

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

  4. Efficacy: overall survival

    To evaluate overall survival.

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

  5. Efficacy: duration of response

    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.

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

Timeline

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

  1. First posted20 Jul 2011 (estimated)
  2. Study startDec 2011
  3. Primary completionOct 2014
  4. Study completionMar 2016

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
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01397877
Sponsor's protocol ID
ENDOPIK
Acronym
ENDOPIK
Status last verified
Sep 2023
First submitted
18 Jul 2011
Last updated
6 Sep 2023
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BKM120 in people with Endometrial Cancer, run by ARCAGY/ GINECO GROUP at 45 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 13 inclusion and 20 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 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 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?

Clinical Efficacy (time frame: 3 months). 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 NCT01397877.

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 6 Sep 2023.

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