Trials
Search / Trial NCT05645536

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 February 05, 2025

Enrolling by invitation

Keywords

Ovarian Suppression Hr+ Her2 Oncology Premenopausal

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.

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

Cordoba, , Argentina

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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