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Email CoordinatorOverview:
TOL2506A-EXT: Open-label, Safety Extension Study for Subjects with Hormone-Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer Who Have Completed the OVarian Suppression Evaluating Subcutaneous LeuprolIde Acetate in Breast Cancer (OVELIA) Study
TOL2506A (OVELIA) is a Phase 3, single arm, open-label study evaluating the effectiveness of TOL2506 in suppressing ovarian function in premenopausal women with HR+, HER2-negative breast cancer and men with HR+ breast cancer. The TOL2506A-EXT study described here is a safety extension study to assess and collect long-term data on the ongoing safety and tolerability of TOL2506 in combination with tamoxifen or an AI for up to 4 years.
Inclusion Criteria:
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
Exclusion Criteria:
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:
Inclusion Criteria:
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:
Exclusion Criteria:
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.