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

Breast Cancer Clinical Trial

Official title:

Open-label, Safety Extension Study for Subjects With HR+, HER2-Negative Breast Cancer Who Have Completed the OVarian Suppression Evaluating Subcutaneous LeuprolIde Acetate in Breast Cancer OVELIA Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05645536
• Other study ID #: TOL2506A-EXT
• Status: Enrolling by invitation
• Phase: Phase 3
• Start date: December 28, 2022
• Est. completion date: June 2028

Study information

• Verified date: March 2024
• Source: Tolmar Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 250
• Est. completion date: June 2028
• Est. primary completion date: June 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 51 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• TOL2506
Leuprolide Acetate for injectable suspension, 30 mg. Subcutaneous injection every 3 months
• Tamoxifen
20 mg once daily or 10 mg 2 times daily - either tablet of solution
• Letrozole tablets
One 2.5 mg tablet taken orally once daily
• Anastrozole Tablets
One 1 mg tablet taken orally once daily
• Exemestane Tablets
One 25 mg tablet taken orally once daily

Locations

Country	Name	City	State
Puerto Rico	FDI Clinical Research	San Juan
United States	Tennessee Oncology, PLLC	Chattanooga	Tennessee
United States	Hematology Oncology Associates of Central New York, PC	East Syracuse	New York
United States	Marin Cancer Care, Inc.	Greenbrae	California
United States	Baptist Health Lexington	Lexington	Kentucky
United States	Baptist Health Louisville	Louisville	Kentucky
United States	Joe Arrington Cancer Research and Treatment Center at Covenant Children's Hospital	Lubbock	Texas
United States	Tennessee Oncology	Nashville	Tennessee
United States	Texas Oncology - San Antonio	New Braunfels	Texas
United States	Fred Hutchinson Cancer Center	Seattle	Washington
United States	Lankenau Medical Center	Wynnewood	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Tolmar Inc.

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The occurrences of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)		4 years from enrolling in study