| CTRI Number |
CTRI/2024/07/070855 [Registered on: 18/07/2024] Trial Registered Prospectively |
| Last Modified On: |
04/05/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
Public Title of Study
Modification(s)
|
Open-label, Safety Extension Study for Subjects with Hormone-Receptor-Positive (HR+), Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer Who Have Completed the Ovarian Suppression Evaluating Subcutaneous LeuprolIde Acetate in Breast Cancer (OVELIA) Study |
Scientific Title of Study
Modification(s)
|
Open-label, Safety Extension Study for Subjects with Hormone-Receptor- Positive (HR+), Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer Who Have Completed the Ovarian Suppression Evaluating Subcutaneous Leuprolide Acetate in Breast Cancer (OVELIA) Study
|
| Trial Acronym |
OVELIA |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| NCT04906395 |
ClinicalTrials.gov |
| TOL2506A EXT, Version 2.0 dated 13/Feb/2023 |
Protocol Number |
| TOL2506A Version 4.0 dated 23/Nov/2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sandeep Singh |
| Designation |
Vice President - Clinical Operations |
| Affiliation |
CBCC Global Research LLP |
| Address |
TURQUOISE-IV, 6th Floor, Sardar Patel Ring Rd, opp. Apple Woods, Near Shantipura circle
Ahmadabad
GUJARAT
382210
India |
| Phone |
9637555304 |
| Fax |
|
| Email |
sandeep.singh@cbccusa.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep Singh |
| Designation |
Vice President - Clinical Operations |
| Affiliation |
CBCC Global Research LLP |
| Address |
TURQUOISE-IV, 6th Floor, Sardar Patel Ring Rd, opp. Apple Woods, Near Shantipura circle
Ahmadabad
GUJARAT
382210
India |
| Phone |
9637555304 |
| Fax |
|
| Email |
sandeep.singh@cbccusa.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandeep Singh |
| Designation |
Vice President - Clinical Operations |
| Affiliation |
CBCC Global Research LLP |
| Address |
TURQUOISE-IV, 6th Floor, Sardar Patel Ring Rd, opp. Apple Woods, Near Shantipura circle
Ahmadabad
GUJARAT
382210
India |
| Phone |
9637555304 |
| Fax |
|
| Email |
sandeep.singh@cbccusa.com |
|
|
Source of Monetary or Material Support
|
| Tolmar, Inc.
701 Centre Avenue
Fort Collins, CO 80526 US
Tel No: (970) 212-4500
|
|
|
Primary Sponsor
|
| Name |
Tolmar, Inc. |
| Address |
701 Centre Avenue
Fort Collins, CO 80526 US
Tel No: (970) 212-4500
Phone: (970) 212-4500
Fax: (970) 212-4950
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| CBCC Global Research LLP |
TURQUOISE-IV, 6th Floor, Sardar Patel Ring Rd, opp. Apple Woods, Near Shantipura circle, Ahmedabad-382210, Gujarat, India |
|
Countries of Recruitment
Modification(s)
|
Mexico
Argentina
Brazil
India
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 15 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr S V S S Prasad |
Apollo Cancer Hospitals |
Apollo Hospitals, Jubilee hills, Hyderabad-500096
Hyderabad
TELANGANA |
9848018804
svss.prasad@yahoo.co.in |
| Dr Boya Rakesh Reddy |
Apollo Hospitals |
Health City, Plot No: 1, Arilova, Chinagadali, Visakhapatnam-530040
Visakhapatnam
ANDHRA PRADESH |
9013355935
drrakeshreddyboya@yahoo.com |
| Dr Velavan Kandappan |
Erode Cancer Centre Private Ltd. |
1/393, Velavan Nagar, Thindal, Erode-638012
Erode
TAMIL NADU |
9842334222
kvels@rediffmail.com |
| Dr Govindaraj Ganesan |
Harshmitra Super Speciality Cancer Centre and Research Institute |
101, 4A, Mathur Panchayat Road, Trichy- Madurai Highway, Nagamangalam, Trichy-620012
Tiruchirappalli
TAMIL NADU |
7373542777
govindarajganesan@gmail.com |
| Dr Lagudu Perraju Bhaskar Bhuvan |
HCG Cancer Centre |
Plot No. 10, Survey No. 13P, APIIC Health City, Arilova, Chinnagadili, Visakhapatnam-530040
Visakhapatnam
ANDHRA PRADESH |
8916682710
drbhaskarbhuvan.lp@hcgel.com |
| Dr Gopichand Mamillapalli |
HCG City Cancer Centre |
33-25-33, CH Venkata Krishnayya Street, Suyarao pet, Vijaywada – 520004
Guntur
ANDHRA PRADESH |
9885256059
mgopichand@yahoo.com |
| Dr Raj Nagarkar |
HCG Manavata Cancer Centre |
Behind Shivang Auto, Mumbai Naka, Nashik-422002
Nashik
MAHARASHTRA |
9823061929
drraj@manavatacancercentre.com |
| Dr Abhishek Kakroo |
Hemato Oncology Clinic Pvt. Ltd. |
Nirmaya Complex Ground Floor to Third Floor, Beside Pandit Dindayal Upadhayay Auditorium, Rajpath Club Road, Off S G Highway, Ahmedabad – 380054
Ahmadabad
GUJARAT |
9974911291
kakrooabhishek@yahoo.com |
| Dr Asma Pathan |
Indrayani hospital and Cancer Institute |
Alandi - chakan road, Alandi, Devachi, Tal. Khed, Dist. Pune -412105
Pune
MAHARASHTRA |
8007167716
asmapathan124@gmail.com |
| Dr Saurabh Prasad |
KIMS-Kingsway Hospitals |
SPANV Medisearch Lifesciences Private Limited, 44, Parwana Bhawan, Kingsway, Nagpur-440001
Nagpur
MAHARASHTRA |
7066580511
drsaurabhprasad@gmail.com |
| Dr Prakash S S |
Mysore Medical College and Research Institute, KR hospital |
Department of Surgical Oncology, Irwin Road, Mysore-570001
Mysore
KARNATAKA |
9901000559
prakashyesyes@yahoo.com |
| Dr Anil Kumar M R |
Oncoville Cancer Hospital and Research Centre |
No. 4, 80 Ft. Road, 7th Block, Nagarbhavi 2nd Stage, Bengaluru - 560072
Bangalore
KARNATAKA |
9739808502
dranil.onco@gmail.com |
| Dr Lokesh K N |
SRV AGADI Hospital and Research Centre |
35, H. Siddaiah Road, Wilson Garden, Bengaluru –560027
Bangalore
KARNATAKA |
8971609070
drlokeshsrv@gmail.com |
| Dr Deepak Kumar Singh |
Swami Harshankaranand Ji Hospital and Research Centre |
N 8/237, Newada, B. H. U. – D. L. W. Road, Newada, Sunderpur, , Varanasi – 221004
Varanasi
UTTAR PRADESH |
9450428608
deepakbhu@gmail.com |
| Dr Ankit Patel |
Unique Hospital Multispeciality and Research Institute |
Opp. Kiran Motor, Nr. Civil Char Rasta, Sosyo Circle Lane, Off. Ring Road, Surat-395002
Surat
GUJARAT |
9825404202
drankitoncologist@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 15 |
| Name of Committee |
Approval Status |
| Ethics committee of CIMS, Care Institute of Medical Sciences |
Approved |
| Ethics Committee, Unique Hospital, |
Approved |
| Institutional Ethics Committee - Clinical Studies |
Approved |
| Institutional Ethics Committee Erode Cancer Centre, |
Approved |
| Institutional Ethics Committee HCG Cancer Centre |
Approved |
| Institutional Ethics Committee Institutional Ethics Committee Mysore Medical College & Research Institute and Associated Hospitals |
Approved |
| Institutional Ethics Committee of OCH and RC |
Approved |
| Institutional Ethics Committee, Harshamitra Superspeciality Cancer Centre |
Approved |
| Institutional Ethics Committee- HCG Curie CCC |
Approved |
| Institutional Ethics Committee-Clinical Studies |
Approved |
| KIMS Kingsway Hospitals Ethics Committee |
Approved |
| Manavata Clinical Research Institute Ethics Committee, |
Approved |
| Medstar Speciality Hospital Ethics Committee |
Approved |
| Narsimha Saraswati Medical Foundation |
Approved |
| Shubham Sudbhawana Super. Hosp. Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z171||Estrogen receptor negative status[ER-], (2) ICD-10 Condition: Z170||Estrogen receptor positive status[ER+], |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Comparator Agent |
NA |
NIL |
| Intervention |
TOL2506 (leuprolide acetate for injectable suspension (30 mg) manufactured by Tolmar, Inc.) |
Dosage: 30 mg /0.4 mL (75 mg/mL)
Route of Administration: Subcutaneous Injection
Duration of Therapy: 205 Weeks
Frequency: Every 3 months for 205 weeks
|
| Intervention |
TOL2506 (leuprolide acetate for injectable suspension (30 mg) manufactured by Tolmar, Inc.) |
Dosage: 30 mg /0.4 mL (75 mg/mL)
Route of Administration: Subcutaneous Injection
Duration of Therapy: 48 weeks
Frequency: Every 3 months for 48 weeks
|
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
51.00 Year(s) |
| Gender |
Both |
| Details |
Details Female:
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.
Male:
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.
|
|
| ExclusionCriteria |
| Details |
Female:
1.Body Mass Index (BMI) less than 18.00 kg/m2
2.Life expectancy less than 12 months
3.ECOG performance status equal to or greater than 3
4.Unacceptable hepatic function as determined by any of the following:
a. Alanine aminotransferase (ALT) greater than or equal to 2 times the upper limit of normal (ULN)
b. Aspartate aminotransferase (AST) greater than or equal to 2 times ULN
c. Bilirubin greater than or equal to 2 times ULN
d. Alkaline phosphatase greater than or equal to 2 times ULN
e. Severe hepatic impairment (Child-Pugh Class C)
5. Unacceptable renal function as determined by any of the following:
a. Creatinine greater than or equal to 3 times ULN
b. Creatinine clearance less than or equal to 30 milliliters per minute
c. Creatinine clearance less than or equal to 60 milliliters per 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:
a. Heart rate greater than 100 beats per minute
b. QRS duration greater than 120 milliseconds
c. Corrected QT interval (QTc) greater than 450 milliseconds
d. PR interval greater than 220 milliseconds
7. Use of any new medications known to prolong the QT or 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:
a. Oral or transdermal hormonal therapy
b. Estrogen, progesterone, or androgens
c. 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 two non-hormonal contraceptive methods throughout the study
12. Is of childbearing potential with a positive urine pregnancy test at screening
Male:
1. Body Mass Index (BMI) less than 18.00 kg/m2
2. Life expectancy less than 12 months
3. ECOG performance status equal to or greater than 3
4. Unacceptable hepatic function as determined by any of the following:
a. Alanine aminotransferase (ALT) greater than or equal to 2 times the upper limit of normal (ULN)
b. Aspartate aminotransferase (AST) greater than or equal to 2 times ULN
c. Bilirubin greater than or equal to 2 times ULN
d. Alkaline phosphatase greater than or equal to 2 times ULN
e. Severe hepatic impairment (Child-Pugh Class C)
5. Unacceptable renal function as determined by any of the following:
a. Creatinine greater than or equal to 3 times ULN
b. Creatinine clearance less than or equal to 30 milliliters per minute
c. Creatinine clearance less than or equal to 60 milliliters per 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:
a. Heart rate greater than 100 beats per minute
b. QRS duration greater than 120 milliseconds
c. Corrected QT interval (QTc) greater than 450 milliseconds
d. PR interval greater than 220 milliseconds
7.Use of any new medications known to prolong the QT or 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
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| To assess the safety and tolerability of TOL2506 in premenopausal subjects with HR+, HER2-negative breast cancer. |
Change from baseline in bone density (time frame: from baseline [ie Visit 2 of the TOL2506A study] until up to Week 205 [Visit 26]) |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| The occurrences of treatment-emergent adverse events (TEAEs) & serious adverse events (SAEs) |
Number of subjects with TEAEs (time frame: from Day 1 until up to Week 205) |
|
Target Sample Size
Modification(s)
|
Total Sample Size="220"
Sample Size from India="43"
Final Enrollment numbers achieved (Total)= "43"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
06/10/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
27/12/2022 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="5"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This
is an open-label, safety extension study that will assess the safety and
tolerability of TOL2506 (leuprolide acetate for injectable suspension, 30 mg)
in combination with tamoxifen or an AI in subjects who participated in the
TOL2506A study. Eligible subjects are those who received 4 injections of
TOL2506, completed the 48-week treatment period and are candidates to continue
receiving TOL2506 as GnRH therapy for the purpose of ovarian suppression. Male
subjects who completed the Week 48 visit of the TOL2506A study can also be
considered for eligibility to enroll in the TOL2506A-EXT study. At
Visit 8 (Week 36) of the TOL2506A study, Investigators will inform subjects of
the potential to enroll in TOL2506A-EXT after they complete their next
scheduled visit (Visit 9; Week 48). At Visit 9, Week 48 of TOL2506A, subjects
will complete the final End-of-Study assessments and eligible subjects will be
offered the option to participate in the TOL2506A-EXT study and continue
receiving their previous TOL2506 + endocrine therapy for up to 4 years.
Eligible subjects will enroll directly from the TOL2506A study into the
TOL2506A-EXT study after having met all eligibility criteria. The assessments
performed at Visit 9, Week 48 of TOL2506A will be used as the Screening
assessments for TOL2506A-EXT (ie, assessments do not need to be repeated for
Screening).
The total duration of the TOL2506A-EXT study is
205 weeks (~4 years). Enrolled subjects will receive TOL2506 every 12 weeks (84
± 3 days) concurrently with their previous treatment of tamoxifen or an AI.
Subjects will be allowed to switch from receiving an AI to receiving tamoxifen
or from tamoxifen to AI at the discretion of the Investigator. Eligible
subjects may continue to receive TOL2506 for up to 4 years |