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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by ARCAGY/ GINECO GROUP
Sponsor:
Information provided by (Responsible Party):
ARCAGY/ GINECO GROUP
ClinicalTrials.gov Identifier:
NCT01397877
First received: July 18, 2011
Last updated: January 9, 2014
Last verified: October 2012

July 18, 2011
January 9, 2014
December 2011
December 2014   (final data collection date for primary outcome measure)
Clinical Efficacy [ Time Frame: 3 months ] [ Designated as safety issue: No ]
To determine the clinical efficacy of BKM120 as monotherapy in the treatment of initial or recurrent metastatic endometrial cancer after first line radio chemotherapy.
Same as current
Complete list of historical versions of study NCT01397877 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: Yes ]
    To assess patient safety and the tolerance of BKM120 administered as monotherapy at the daily dose of 100 mg.
  • Efficacy: PFS [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    To evaluate progression-free survival
  • Efficacy: ORR [ Time Frame: Patient will be followed for the duration of the study, an expected average of 75 days ] [ Designated as safety issue: No ]
    To evaluate the objective response rate according to RECIST 1.1
  • Efficacy: overall survival [ Time Frame: Patients will be followed for an expected average of 1 year and 75 days ] [ Designated as safety issue: No ]
    To evaluate overall survival.
  • Efficacy: duration of response [ Time Frame: Patients will be followed for an expected average of 1 year and 75 days ] [ Designated as safety issue: No ]

    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.

Same as current
Not Provided
Not Provided
 
GINECO-EN102b - BKM120 as Monotherapy in the Treatment of Initial or Recurrent Metastatic Endometrial Cancer
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

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Endometrial Cancer
Drug: BKM120
per os, 60mg/j, until progression or unacceptable toxicity
Experimental: stratum 1
Patients with low grade disease (grade 1 or 2) with positive or negative mutational status
Intervention: Drug: BKM120
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
56
September 2016
December 2014   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact: Virginie Thouviot 01 42 34 83 23 vthouviot@arcagy.org
France
 
NCT01397877
ENDOPIK
Yes
ARCAGY/ GINECO GROUP
ARCAGY/ GINECO GROUP
Not Provided
Principal Investigator: Isabelle Ray-Coquard, MD GINECO - Centre Léon Bérard
ARCAGY/ GINECO GROUP
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP