Safety Extension Study for Subjects With HR+, HER2- Breast Cancer for Subjects Who Have Completed the OVELIA Study
Launched by TOLMAR INC. · Dec 1, 2022
Trial Information
Current as of January 16, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- Females:
- • 1. Completed Visit 9, Week 48 visit of TOL2506A study and is a candidate for continued endocrine therapy + ovarian suppression
- • 2. Able to understand the investigational nature of this study and provide written informed consent prior to the participation in the trial
- • 3. Age 18 to 51 inclusive
- Exclusion Criteria:
- * Females:
- • 1. Body mass index (BMI) \< 18.00 kg/m2
- • 2. Life expectancy \< 12 months
- • 3. ECOG performance status ≥ 3
- 4. Unacceptable hepatic function as determined by any of the following:
- • 1. Alanine aminotransferase (ALT) ≥ 2X upper limit of normal (ULN)
- • 2. Aspartate aminotransferase (AST) ≥ 2X ULN
- • 3. Bilirubin ≥ 2X ULN
- • 4. Alkaline phosphatase ≥ 2X ULN
- • 5. Severe hepatic impairment (Child-Pugh Class C)
- 5. Unacceptable renal function as determined by any of the following:
- • 1. Creatinine ≥ 3X ULN
- • 2. Creatinine clearance ≤ 30 mL/minute
- • 3. Creatinine clearance ≤ 60 mL/minute in subjects with bone density 1.5 standard deviations below the young adult normal mean
- 6. Screening 12-lead ECG demonstrating any of the following:
- • 1. Heart rate \> 100 beats per minute (BPM)
- • 2. QRS \> 120 msec
- • 3. Corrected QT (QTc) \> 450 msec
- • 4. PR \> 220 msec
- • 7. Use of any new medications known to prolong the QT/QTc interval
- • 8. 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
- 9. Concomitant use of medications that may impact subject safety including but not limited to:
- • 1. Oral or transdermal hormonal therapy
- • 2. Estrogen, progesterone, or androgens
- • 3. Hormonal contraceptives
- • 10. Change in tolerability to TOL2506 that precludes continued treatment
- • 11. Sexually active with a male partner and not willing to use at least 2 non-hormonal contraceptive methods throughout the study
- • 12. Is of childbearing potential with a positive urine pregnancy test at Screening
- Males:
- Inclusion Criteria:
- • 1. Completed Visit 9, Week 48 visit of TOL2506A study and is a candidate for continued endocrine + GnRH agonist therapy
- • 2. Able to understand the investigational nature of this study and provide written informed consent prior to participation in the trial
- Males:
- Exclusion Criteria:
- • 1. BMI \< 18.00 kg/m2
- • 2. Life expectancy \< 12 months
- • 3. ECOG performance status ≥ 3
- 4. Unacceptable hepatic function as determined by any of the following:
- • 1. ALT ≥ 2X ULN
- • 2. AST ≥ 2X ULN
- • 3. Bilirubin ≥ 2X ULN
- • 4. Alkaline phosphatase ≥ 2X ULN
- • 5. Severe hepatic impairment (Child-Pugh Class C)
- 5. Unacceptable renal function as determined by any of the following:
- • 1. Creatinine ≥ 3X ULN
- • 2. Creatinine clearance ≤ 30 mL/minute
- • 3. Creatinine clearance ≤ 60 mL/minute in subjects with bone density 1.5 standard deviations below the young adult normal mean
- 6. Screening 12-lead ECG demonstrating any of the following:
- • 1. HR \> 100 BPM
- • 2. QRS \> 120 msec
- • 3. QTc \> 450 msec
- • 4. PR \> 220 msec
- • 7. Use of any new medications known to prolong the QT/QTc interval
- • 8. 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
- • 9. Concomitant use of medications that may impact subject safety including but not limited to oral or transdermal hormonal therapy
- • 10. Change in tolerability to TOL2506 that precludes continued treatment.
About Tolmar Inc.
Tolmar Inc. is a privately held pharmaceutical company focused on the development and commercialization of innovative therapeutic products in the urology and oncology sectors. With a commitment to improving patient outcomes, Tolmar leverages advanced research and development capabilities to address unmet medical needs. The company aims to enhance the quality of care through its proprietary formulations and strategic partnerships, ensuring that patients have access to effective and safe treatment options. Driven by a patient-centric approach, Tolmar is dedicated to advancing healthcare solutions that make a meaningful difference in the lives of those it serves.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Wynnewood, Pennsylvania, United States
Fort Lauderdale, Florida, United States
Seattle, Washington, United States
Columbia, Maryland, United States
Lexington, Kentucky, United States
Nashville, Tennessee, United States
Louisville, Kentucky, United States
Chattanooga, Tennessee, United States
Greenbrae, California, United States
Caba, , Argentina
San Juan, , Puerto Rico
East Syracuse, New York, United States
Longview, Texas, United States
Rosario, Santa Fe, Argentina
Goiania, Goias, Brazil
Fortaleza, Ceara, Brazil
Porto Velho, Rondonia, Brazil
Lubbock, Texas, United States
New Braunfels, Texas, United States
Fayetteville, North Carolina, United States
Córdoba, , Argentina
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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