Tolmar Inc.
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.
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…
Leuprolide Acetate for injectable suspension, 30 mg. Subcutaneous injection every 3 months
20 mg once daily or 10 mg 2 times daily - either tablet of solution
One 2.5 mg tablet taken orally once daily
One 1 mg tablet taken orally once daily
One 25 mg tablet taken orally once daily