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Enrolling By Invitation
NCT05645536
Safety Extension Study for Subjects With HR+, HER2- Breast Cancer for Subjects Who Have Completed the OVELIA Study
Conditions: Breast Cancer
Sex: All
Ages: 18 Years – 51 Years
Phase: PHASE3
Enrollment: 250
Sponsor: Tolmar Inc.
Location: United States
Summary
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.
Eligibility Criteria
Inclusion Criteria:Females:Completed Visit 9, Week 48 visit of TOL2506A study and is a candidate for continued endocrine therapy + ovarian suppressionAble to understand the investigational nature of this study and provide written informed consent prior to the participation in the trialAge 18 to 51 inclusiveExclusion Criteria:Females:Body mass index (BMI) < 18.00 kg/m2 or > 35.00 kg/m2Life expectancy < 12 monthsECOG performance status ≥ 3Unacceptable hepatic function as determined by any of the following:Alanine aminotransferase (ALT) ≥ 2X upper limit of normal (ULN)Aspartate aminotransferase (AST) ≥ 2X ULNBilirubin ≥ 2X ULNAlkaline phosphatase ≥ 2X ULNSevere hepatic impairment (Child-Pugh Class C)Unacceptable renal function as determined by any of the following:Creatinine ≥ 3X ULNCreatinine clearance ≤ 30 mL/minuteCreatinine clearance ≤ 60 mL/minute in subjects with bone density 1.5 standard deviations below the young adult normal meanScreening 12-lead ECG demonstrating any of the following:Heart rate > 100 beats per minute (BPM)QRS > 120 msecCorrected QT (QTc) > 450 msecPR > 220 msecUse of any new medications known to prolong the QT/QTc intervalAny 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 TOL2506Concomitant use of medications that may impact subject safety including but not limited to:Oral or transdermal hormonal therapyEstrogen, progesterone, or androgensHormonal contraceptivesChange in tolerability to TOL2506 that precludes continued treatmentSexually active with a male partner and not willing to use at least 2 non-hormonal contraceptive methods throughout the studyIs of childbearing potential with a positive urine pregnancy test at ScreeningMales:Inclusion Criteria:Completed Visit 9, Week 48 visit of TOL2506A study and is a candidate for continued endocrine + GnRH agonist therapyAble to understand the investigational nature of this study and provide written informed consent prior to participation in the trialMales:Exclusion Criteria:BMI < 18.00 kg/m2Life expectancy < 12 monthsECOG performance status ≥ 3Unacceptable hepatic function as determined by any of the following:ALT ≥ 2X ULNAST ≥ 2X ULNBilirubin ≥ 2X ULNAlkaline phosphatase ≥ 2X ULNSevere hepatic impairment (Child-Pugh Class C)Unacceptable renal function as determined by any of the following:Creatinine ≥ 3X ULNCreatinine clearance ≤ 30 mL/minuteCreatinine clearance ≤ 60 mL/minute in subjects with bone density 1.5 standard deviations below the young adult normal meanScreening 12-lead ECG demonstrating any of the following:HR > 100 BPMQRS > 120 msecQTc > 450 msecPR > 220 msecUse of any new medications known to prolong the QT/QTc intervalAny 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 TOL2506Concomitant use of medications that may impact subject safety including but not limited to oral or transdermal hormonal therapyChange in tolerability to TOL2506 that precludes continued treatment.
Source: ClinicalTrials.gov (NCT05645536). StuddyBuddy aggregates publicly available trial information.
