Resumen

TOL2506A (OVELIA) es un estudio de fase 3, de brazo único y abierto que evalúa la eficacia de TOL2506 para suprimir la función ovárica en mujeres premenopáusicas con cáncer de mama HR+, HER2-negativo y en hombres con cáncer de mama HR+. El estudio TOL2506A-EXT descripto aquí es un estudio de extensión de seguridad para evaluar y recopilar datos a largo plazo sobre la seguridad y tolerabilidad en curso de TOL2506 en combinación con tamoxifeno o un inhibidor de la aromatasa (IA) durante hasta 4 años.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 51 YearsSexo: ALL

Criterios de inclusión

Females:
Completed Visit 9, Week 48 visit of TOL2506A study and is a candidate for continued endocrine therapy + ovarian suppression
Able to understand the investigational nature of this study and provide written informed consent prior to the participation in the trial
Age 18 to 51 inclusive
Completed Visit 9, Week 48 visit of TOL2506A study and is a candidate for continued endocrine + GnRH agonist therapy
Able to understand the investigational nature of this study and provide written informed consent prior to participation in the trial
Males:

Criterios de exclusión

Females:
Body mass index (BMI) \< 18.00 kg/m2
Life expectancy \< 12 months
ECOG performance status ≥ 3
Unacceptable hepatic function as determined by any of the following:
Alanine aminotransferase (ALT) ≥ 2X upper limit of normal (ULN)
Aspartate aminotransferase (AST) ≥ 2X ULN
Bilirubin ≥ 2X ULN
Alkaline phosphatase ≥ 2X ULN
Severe hepatic impairment (Child-Pugh Class C)
Unacceptable renal function as determined by any of the following:
Creatinine ≥ 3X ULN
Creatinine clearance ≤ 30 mL/minute
Creatinine clearance ≤ 60 mL/minute in subjects with bone density 1.5 standard deviations below the young adult normal mean
Screening 12-lead ECG demonstrating any of the following:
Heart rate \> 100 beats per minute (BPM)
QRS \> 120 msec
Corrected QT (QTc) \> 450 msec
PR \> 220 msec
Use of any new medications known to prolong the QT/QTc interval
Any new medical condition or psychiatric, addictive or other disorder that, in the opinion of the Investigator, may interfere with trial conduct or result in the subject being ineligible to continue treatment with TOL2506
Concomitant use of medications that may impact subject safety including but not limited to:
Oral or transdermal hormonal therapy
Estrogen, progesterone, or androgens
Hormonal contraceptives
Change in tolerability to TOL2506 that precludes continued treatment
Sexually active with a male partner and not willing to use at least 2 non-hormonal contraceptive methods throughout the study
Is of childbearing potential with a positive urine pregnancy test at Screening
Males:
BMI \< 18.00 kg/m2
Life expectancy \< 12 months
ECOG performance status ≥ 3
Unacceptable hepatic function as determined by any of the following:
ALT ≥ 2X ULN
AST ≥ 2X ULN
Bilirubin ≥ 2X ULN
Alkaline phosphatase ≥ 2X ULN
Severe hepatic impairment (Child-Pugh Class C)
Unacceptable renal function as determined by any of the following:
Creatinine ≥ 3X ULN
Creatinine clearance ≤ 30 mL/minute
Creatinine clearance ≤ 60 mL/minute in subjects with bone density 1.5 standard deviations below the young adult normal mean
Screening 12-lead ECG demonstrating any of the following:
HR \> 100 BPM
QRS \> 120 msec
QTc \> 450 msec
PR \> 220 msec
Use of any new medications known to prolong the QT/QTc interval
Any new medical condition or psychiatric, addictive or other disorder that, in the opinion of the Investigator, may interfere with trial conduct or result in the subject being ineligible to continue treatment with TOL2506
Concomitant use of medications that may impact subject safety including but not limited to oral or transdermal hormonal therapy
Change in tolerability to TOL2506 that precludes continued treatment.

Intervenciones

drug

TOL2506

Leuprolide Acetate for injectable suspension, 30 mg. Subcutaneous injection every 3 months

drug

Tamoxifen

20 mg once daily or 10 mg 2 times daily - either tablet of solution

drug

Letrozole tablets

One 2.5 mg tablet taken orally once daily

drug

Anastrozole Tablets

One 1 mg tablet taken orally once daily

drug

Exemestane Tablets

One 25 mg tablet taken orally once daily

Estudio de Extensión de Seguridad Abierto para Sujetos con Cáncer de Mama HR+, HER2-Negativo que Han Completado el Estudio OVELIA de Supresión OVárica que Evalúa el Acetato de Leuprolida Subcutáneo en Cáncer de Mama

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

TOL2506

Tamoxifen

Letrozole tablets

Anastrozole Tablets

Exemestane Tablets

Ubicaciones

Instituto Medico de la Fundacion Estudios Clinicos

Hospital Aleman

Fundacion CENIT

Instituto Oncologico de Cordoba (IONC)

Centro Privado de MRI de Rio Cuarto SA

Sanatorio Allende

Patrocinadores