Phase 2 multicenter study to assess the safety and efficacy of BKM120 as monotherapy in the treatment of initial or recurrent metastatic endometrial cancer after first line therapy in patients who cannot undergo local surgery and/or radiotherapy. - ENDOPIK

ARCAGY0 sitesJuly 4, 2011

Conditionsinitial or recurrent metastatic endometrial cancer after first line therapy in patients who cannot undergo local surgery and/or radiotherapy.Therapeutic area: Diseases [C] - Cancer [C04]

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: initial or recurrent metastatic endometrial cancer after first line therapy in patients who cannot undergo local surgery and/or radiotherapy.
Sponsor: ARCAGY
Status: Active, not recruiting
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 4, 2011

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Investigators

Sponsor

ARCAGY

Eligibility Criteria

Inclusion Criteria

•Female \= 18 years old.
•ECOG performance index 0\-2\.
•Patient with histological confirmed endometrial cancer.
•Patient who is not eligible for exclusive curative treatment by surgery and/or radiotherapy.
•Patient with initial metastatic endometrial cancer that has not been treated with chemotherapy or radiotherapy prior to inclusion
•Patient with recurrent endometrial cancer previously treated with adjuvant chemotherapy and radiotherapy, presenting with a disease\-free interval (period between the date of the last dose of chemotherapy and relapse) of at least 12 months.
•Presence of one or more measurable lesion(s) outside the irradiated areas.
•Availability at the time of inclusion of samples of tumor tissue, in the form of archived tissue (a block or at least 20 unstained slides) for tumor sub\-classification (low grade \= stratum 1; high grade \= stratum 2\) and for routine molecular analysis.
•Satisfactory biological functions
•Life expectancy 3 months.

Exclusion Criteria

•Previous treatment with PI3K inhibitors and/or mTOR.
•Presence of symptomatic central nervous system (CNS) metastases.
•Concomitant presence or history of another malignant tumor in the past 3 years prior to inclusion in the study (with the exception of spinocellular or cutaneous basal cell epithelioma or non\-melanomatous skin cancer treated successfully).
•Patient suffering from one of the following mood disorders based on an evaluation by the investigator or a psychiatrist OR with a limit score of \= 10 on the PHQ\-9 (Patient Health Questionnaire) OR a limit score of \= 15 on the GAD\-7 mood evaluation scale, respectively, OR with a positive response of 1, 2, or 3 to question number 9 relating to suicidal ideation in the PHQ\-9 questionnaire (regardless of the overall score obtained in PHQ\-9\).
•o Medically documented earlier or active major depressive episodes, bipolar disorders (I or II), compulsive obsessive disorders, schizophrenia, history of suicide attempts or suicidal ideation or homicidal ideation (immediate risk of harming another person).
•o Anxiety \= grade 3 CTCAE
•Concomitant administration of another approved or investigational anticancer agent (hormonal agents included).
•Pelvic and/or para\-aortic radiotherapy within \= 28 days prior to inclusion in the study or persistent side effects from this treatment on implementation of the selection procedures.
•Major surgery during the 28 days prior to starting the investigational drug or persistent side effects from surgery.
•Uncontrolled diabetes (HbA1c \> 8 %).