Safety Extension Study for Subjects With HR+, HER2- Breast Cancer for Subjects Who Have Completed the OVELIA Study

Phase 3

• Conditions: Breast Cancer
• Interventions: Drug: TOL2506; Drug: Tamoxifen; Drug: Letrozole tablets; Drug: Anastrozole Tablets; Drug: Exemestane Tablets

• Registration Number: NCT05645536
• Lead Sponsor: Tolmar Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-01
• Study First Submitted QC: 2022-12-01
• Study First Posted: 2022-12-09
• Study Start: 2022-12-28
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-30
• Last Update Posted: 2025-05-02
• Primary Completion: 2028-06
• Study Completion: 2028-06

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 250

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TOL2506	Exemestane Tablets	TOL2506 in combination with standard endocrine therapy (Tamoxifen \& Aromatase Inhibitors)
TOL2506	Letrozole tablets	TOL2506 in combination with standard endocrine therapy (Tamoxifen \& Aromatase Inhibitors)
TOL2506	Anastrozole Tablets	TOL2506 in combination with standard endocrine therapy (Tamoxifen \& Aromatase Inhibitors)
TOL2506	TOL2506	TOL2506 in combination with standard endocrine therapy (Tamoxifen \& Aromatase Inhibitors)
TOL2506	Tamoxifen	TOL2506 in combination with standard endocrine therapy (Tamoxifen \& Aromatase Inhibitors)

Primary Outcome Measures

Name	Time	Method
The occurrences of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)	4 years from enrolling in study

Trial Locations

Locations (25)

Texas Oncology - Central South; 🇺🇸 Austin, Texas, United States

Irmandade Santa Casa de Misericordia de Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil

Marin Cancer Care, Inc.; 🇺🇸 Greenbrae, California, United States

Holy Cross Hospital; 🇺🇸 Fort Lauderdale, Florida, United States

Baptist Health Lexington; 🇺🇸 Lexington, Kentucky, United States

Baptist Health Louisville; 🇺🇸 Louisville, Kentucky, United States

Maryland Oncology Hematology, P.A.; 🇺🇸 Columbia, Maryland, United States

Hematology Oncology Associates of Central New York, PC; 🇺🇸 East Syracuse, New York, United States

Cape Fear Valley Health Systems - Cancer Center; 🇺🇸 Fayetteville, North Carolina, United States

Lankenau Medical Center; 🇺🇸 Wynnewood, Pennsylvania, United States

Tennessee Oncology, PLLC; 🇺🇸 Chattanooga, Tennessee, United States

Tennessee Oncology; 🇺🇸 Nashville, Tennessee, United States

Texas Oncology - Northeast Texas; 🇺🇸 Longview, Texas, United States

Joe Arrington Cancer Research and Treatment Center at Covenant Children's Hospital; 🇺🇸 Lubbock, Texas, United States

Texas Oncology - San Antonio; 🇺🇸 New Braunfels, Texas, United States

Fred Hutchinson Cancer Center; 🇺🇸 Seattle, Washington, United States

Instituto Medico de la Fundacion Estudios Clinicos; 🇦🇷 Rosario, Santa Fe, Argentina

Hospital Aleman; 🇦🇷 Caba, Argentina

Instituto Oncologico de Cordoba (IONC); 🇦🇷 Cordoba, Argentina

Centro Privado de MRI de Rio Cuarto SA; 🇦🇷 Córdoba, Argentina

Centro Regional Integrado de Oncologia; 🇧🇷 Fortaleza, Ceara, Brazil

Hospital Araujo Jorge; 🇧🇷 Goiania, Goias, Brazil

Hospital de Amor Amazonia; 🇧🇷 Porto Velho, Rondonia, Brazil

Fundacao Pio XII - Hospital de Amor Barretos; 🇧🇷 São Paulo, Brazil

FDI Clinical Research; 🇵🇷 San Juan, Puerto Rico