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

Sponsor

Tolmar Inc. (Industry)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05645536

Collaborator

(none)

250

Enrollment

Locations

Arm

65.1

Anticipated Duration (Months)

125

Patients Per Site

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: TOL2506 Drug: Tamoxifen Drug: Letrozole tablets Drug: Anastrozole Tablets Drug: Exemestane Tablets	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

250 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Dec 28, 2022

Anticipated Primary Completion Date :

Jun 1, 2028

Anticipated Study Completion Date :

Jun 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TOL2506 TOL2506 in combination with standard endocrine therapy (Tamoxifen & Aromatase Inhibitors)	Drug: TOL2506 Leuprolide Acetate for injectable suspension, 30 mg. Subcutaneous injection every 3 months Drug: Tamoxifen 20 mg once daily or 10 mg 2 times daily - either tablet of solution Drug: Letrozole tablets One 2.5 mg tablet taken orally once daily Drug: Anastrozole Tablets One 1 mg tablet taken orally once daily Drug: Exemestane Tablets One 25 mg tablet taken orally once daily

Arm

Intervention/Treatment

Experimental: TOL2506

TOL2506 in combination with standard endocrine therapy (Tamoxifen & Aromatase Inhibitors)

Drug: TOL2506

Leuprolide Acetate for injectable suspension, 30 mg. Subcutaneous injection every 3 months

Drug: Tamoxifen

20 mg once daily or 10 mg 2 times daily - either tablet of solution

Drug: Letrozole tablets

One 2.5 mg tablet taken orally once daily

Drug: Anastrozole Tablets

One 1 mg tablet taken orally once daily

Drug: Exemestane Tablets

One 25 mg tablet taken orally once daily

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 51 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Females:

Completed Visit 9, Week 48 visit of TOL2506A study and is a candidate for continued endocrine therapy + ovarian suppression
Able to understand the investigational nature of this study and provide written informed consent prior to the participation in the trial
Age 18 to 51 inclusive

Exclusion Criteria:

Females:

Body mass index (BMI) < 18.00 kg/m2 or > 35.00 kg/m2
Life expectancy < 12 months
ECOG performance status ≥ 3
Unacceptable hepatic function as determined by any of the following:
Alanine aminotransferase (ALT) ≥ 2X upper limit of normal (ULN)
Aspartate aminotransferase (AST) ≥ 2X ULN
Bilirubin ≥ 2X ULN
Alkaline phosphatase ≥ 2X ULN
Severe hepatic impairment (Child-Pugh Class C)
Unacceptable renal function as determined by any of the following:
Creatinine ≥ 3X ULN
Creatinine clearance ≤ 30 mL/minute
Creatinine clearance ≤ 60 mL/minute in subjects with bone density 1.5 standard deviations below the young adult normal mean
Screening 12-lead ECG demonstrating any of the following:
Heart rate > 100 beats per minute (BPM)
QRS > 120 msec
Corrected QT (QTc) > 450 msec
PR > 220 msec
Use of any new medications known to prolong the QT/QTc interval
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
Concomitant use of medications that may impact subject safety including but not limited to:
Oral or transdermal hormonal therapy
Estrogen, progesterone, or androgens
Hormonal contraceptives
Change in tolerability to TOL2506 that precludes continued treatment
Sexually active with a male partner and not willing to use at least 2 non-hormonal contraceptive methods throughout the study
Is of childbearing potential with a positive urine pregnancy test at Screening

Males:

Inclusion Criteria:

Completed Visit 9, Week 48 visit of TOL2506A study and is a candidate for continued endocrine + GnRH agonist therapy
Able to understand the investigational nature of this study and provide written informed consent prior to participation in the trial

Males:

Exclusion Criteria:

BMI < 18.00 kg/m2
Life expectancy < 12 months
ECOG performance status ≥ 3
Unacceptable hepatic function as determined by any of the following:
ALT ≥ 2X ULN
AST ≥ 2X ULN
Bilirubin ≥ 2X ULN
Alkaline phosphatase ≥ 2X ULN
Severe hepatic impairment (Child-Pugh Class C)
Unacceptable renal function as determined by any of the following:
Creatinine ≥ 3X ULN
Creatinine clearance ≤ 30 mL/minute
Creatinine clearance ≤ 60 mL/minute in subjects with bone density 1.5 standard deviations below the young adult normal mean
Screening 12-lead ECG demonstrating any of the following:
HR > 100 BPM
QRS > 120 msec
QTc > 450 msec
PR > 220 msec
Use of any new medications known to prolong the QT/QTc interval
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
Concomitant use of medications that may impact subject safety including but not limited to oral or transdermal hormonal therapy
Change in tolerability to TOL2506 that precludes continued treatment.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Baptist Health Lexington	Lexington	Kentucky	United States	40503
2	Hematology Oncology Associates of Central New York, PC	East Syracuse	New York	United States	13057