Clinical trial NCT05645536: Safety Extension Study for Subjects With HR+, HER2- Breast Cancer for Subjects Who Have Completed the OVELIA Study
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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE3
Conditions: Breast Cancer
Keywords: Ovarian Suppression
HR+
HER2-
Oncology
Premenopausal
Lead sponsor: Tolmar Inc.
Sponsor class: INDUSTRY
First posted: 2022-12-09
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 51
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: The occurrences of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
timeFrame: 4 years from enrolling in study
Secondary outcomes:
Other outcomes:
Locations:
city: Greenbrae
country: United States
facility: Marin Cancer Care, Inc.
state: California
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital
state: Florida
city: Lexington
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: Louisville
country: United States
facility: Baptist Health Louisville
state: Kentucky
city: Columbia
country: United States
facility: Maryland Oncology Hematology, P.A.
state: Maryland
city: East Syracuse
country: United States
facility: Hematology Oncology Associates of Central New York, PC
state: New York
city: Fayetteville
country: United States
facility: Cape Fear Valley Health Systems - Cancer Center
state: North Carolina
city: Wynnewood
country: United States
facility: Lankenau Medical Center
state: Pennsylvania
city: Chattanooga
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology
state: Tennessee
city: Austin
country: United States
facility: Texas Oncology - Central South
state: Texas
city: Longview
country: United States
facility: Texas Oncology - Northeast Texas
state: Texas
city: Lubbock
country: United States
facility: Joe Arrington Cancer Research and Treatment Center at Covenant Children's Hospital
state: Texas
city: New Braunfels
country: United States
facility: Texas Oncology - San Antonio
state: Texas
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Center
state: Washington
city: Rosario
country: Argentina
facility: Instituto Medico de la Fundacion Estudios Clinicos
state: Santa Fe
city: Caba
country: Argentina
facility: Hospital Aleman
city: Cordoba
country: Argentina
facility: Instituto Oncologico de Cordoba (IONC)
city: Córdoba
country: Argentina
facility: Centro Privado de MRI de Rio Cuarto SA
city: Fortaleza
country: Brazil
facility: Centro Regional Integrado de Oncologia
state: Ceara
city: Goiania
country: Brazil
facility: Hospital Araujo Jorge
state: Goias
city: Porto Alegre
country: Brazil
facility: Irmandade Santa Casa de Misericordia de Porto Alegre
state: Rio Grande Do Sul
city: Porto Velho
country: Brazil
facility: Hospital de Amor Amazonia
state: Rondonia
city: São Paulo
country: Brazil
facility: Fundacao Pio XII - Hospital de Amor Barretos
city: San Juan
country: Puerto Rico
facility: FDI Clinical Research
Study officials:
References: