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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT05486143




Registration number
NCT05486143
Ethics application status
Date submitted
25/07/2022
Date registered
3/08/2022
Date last updated
3/08/2022

Titles & IDs
Public title
Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer
Scientific title
Phase 3, Open-Label, Randomized, Study Comparing Gedatolisib Combined With Fulvestrant & With or Without Palbociclib to Standard-of-Care Therapies in Patients With HR-Positive, HER2-Negative Advanced Breast Cancer Previously Treated With a CDK4/6 Inhibitor in Combination w/Non-Steroidal Aromatase Inhibitor Therapy
Secondary ID [1] 0 0
2021-005235-24
Secondary ID [2] 0 0
CELC-G-301
Universal Trial Number (UTN)
Trial acronym
VIKTORIA-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Gedatolisib
Treatment: Drugs - Palbociclib
Treatment: Drugs - Fulvestrant
Treatment: Drugs - Alpelisib

Experimental: Arm A - Patients Lacking PIK3CA Mutations (WT) - Gedatolisib + Palbociclib + Fulvestrant

Experimental: Arm B - Patients Lacking PIK3CA Mutations (WT) - Gedatolisib + Fulvestrant

Active Comparator: Arm C - Patients Lacking PIK3CA Mutations (WT) - Fulvestrant

Experimental: Arm D - Patients with PIK3CA Mutation (MT) - Gedatolisib + Palbociclib + Fulvestrant

Active Comparator: Arm E - Patients with PIK3CA Mutation (MT) - Alpelisib + Fulvestrant

Experimental: Arm F - Patients with PIK3CA Mutation (MT) - Gedatolisib + Fulvestrant


Treatment: Drugs: Gedatolisib
Gedatolisib 180 mg IV given weekly for 3 weeks (Days 1, 8, 15) followed by 1 week off

Treatment: Drugs: Palbociclib
Palbociclib 125 mg PO given daily for 3 weeks (21 days), followed by 1 week off

Treatment: Drugs: Fulvestrant
Fulvestrant 500 mg IM (2 × 5 mL injections) given every 2 weeks during Cycle 1 (Days 1 and 15), then every 4 weeks beginning with Cycle 2 Day 1

Treatment: Drugs: Alpelisib
Alpelisib 300 mg PO (2 × 150 mg tablets) given daily for 4 weeks (28 days)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
Timepoint [1] 0 0
Approximately 48 months
Secondary outcome [1] 0 0
Overall Survival (OS) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
Timepoint [1] 0 0
From date of randomization to the date of death due to any cause, up to approximately 48 months
Secondary outcome [2] 0 0
Overall Response Rate (ORR) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
Timepoint [2] 0 0
Up to approximately 48 months
Secondary outcome [3] 0 0
Duration of Response (DOR) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
Timepoint [3] 0 0
Up to approximately 48 months
Secondary outcome [4] 0 0
Time to Response (TTR) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
Timepoint [4] 0 0
Up to approximately 48 months
Secondary outcome [5] 0 0
Clinical Benefit Rate (CBR) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
Timepoint [5] 0 0
Up to approximately 48 months
Secondary outcome [6] 0 0
Quality of Life (QOL)Functional Assessment of Cancer Therapy - Breast Trial Outcome Index (FACT-B TOI) Questions in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
Timepoint [6] 0 0
From baseline to 30 Day Safety Follow-up
Secondary outcome [7] 0 0
Quality of Life (QOL) NCCN-FACT Breast Symptom Index -16 (NFBSI-16) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
Timepoint [7] 0 0
From baseline to 30 Day Safety Follow-up
Secondary outcome [8] 0 0
Patient-Reported Outcomes in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
Timepoint [8] 0 0
From baseline to 30 Day Safety Follow-up
Secondary outcome [9] 0 0
EuroQol 5 in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
Timepoint [9] 0 0
From baseline to 30 Day Safety Follow-up

Eligibility
Key inclusion criteria
1. Histologically or cytologically confirmed diagnosis of metastatic or locally advanced
breast cancer Adult females, pre- and/or post-menopausal, and adult males.
Pre-menopausal (and peri-menopausal) women can be enrolled if amenable to treatment
with an LHRH agonist. Patients are to have commenced concomitant treatment with LHRH
agonist prior to or on Cycle 1, Day 1 and must be willing to continue on it for the
duration of the study.

2. Negative pregnancy test for women who are not surgically sterile. Female subjects who
are not surgically sterile must use a medically-effective contraceptive method from
screening until 1 year after the last dose of study treatment

3. Confirmed diagnosis of estrogen receptor positive and/or progesterone receptor
positive, as per American Society of Clinical Oncology/College of American
Pathologists (ASCO-CAP) guidelines (2020), based on most recent tumor biopsy utilizing
an assay consistent with local standards

4. Documented HER2 immunohistochemistry (IHC) negative as per ASCO-CAP 2018 guidance

5. Adequate archival or fresh tumor tissue for the analysis of PIK3CA mutational status

6. Subject has radiologically evaluable disease (measurable and/or non-measurable)
according to RECIST v1.1, per local assessment. Mixed lytic/blastic or lytic lesions
with measurable soft tissue component are allowed.

7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

8. Life expectancy of at least 3 months

9. Progressed during or after CDK4/6 inhibitor combination treatment with non-steroidal
aromatase inhibitor (AI)

10. Adequate bone marrow, hepatic, renal and coagulation function
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. History of malignancies other than adequately treated non-melanoma skin cancer,
curatively treated in situ cancer of the cervix, or other solid tumors curatively
treated with no evidence of disease for =3 years

2. Prior treatment with a phosphoinositide 3-kinase (PI3K) inhibitor, a protein kinase B
(Akt) inhibitor, or a mechanistic target of rapamycin (mTOR) inhibitor

3. More than one prior treatment with chemotherapy for advanced disease (prior adjuvant
or neoadjuvant chemotherapy is permitted)

4. More than 2 lines of prior endocrine therapy treatment

5. Bone only disease that is only blastic with no soft tissue component

6. Subjects with type 1 diabetes or uncontrolled type 2 diabetes

7. Known and untreated, or active, brain or leptomeningeal metastases

a. Subjects with previously treated central nervous system (CNS) metastases may be
enrolled in the study if they meet the following criteria: do not require supportive
therapy with steroids; do not have seizures and do not exhibit uncontrolled
neurological symptoms; stable disease confirmed by radiographic assessment within at
least 4 weeks prior to enrollment

8. Patients with advanced, symptomatic, visceral spread that are at risk of
life-threatening complication in the short-term

9. History of clinically significant cardiovascular abnormalities such as: Congestive
heart failure (New York Heart Association (NYHA) classification = II within 6 months
of study entry

1. Myocardial infarction within 12 months of study entry

2. History of any cardiac arrhythmias, (e.g., ventricular tachycardia), complete
left bundle branch block, high grade AV block (e.g., bifascicular block, Mobitz
type II and third degree AV block), supraventricular, nodal arrhythmias, or
conduction abnormality in the previous 12 months

3. Uncontrolled hypertension defined by systolic blood pressure (SBP) =160 mmHg
and/or diastolic blood pressure (DBP) =100 mmHg, with or without antihypertensive
medication (initiation or adjustment of antihypertensive medication[s] is allowed
prior to screening)

4. Long QT syndrome, family history of idiopathic sudden death or congenital long QT
syndrome, or any of the following:

- i. Risk factors for Torsades de Pointes (TdP) including uncorrected
hypokalemia or hypomagnesemia, history of cardiac failure, or history of
clinically significant/symptomatic bradycardia

- ii. Concomitant medication(s) with a known risk to prolong the QT interval
and/or known to cause TdP that cannot be discontinued or replaced by safe
alternative medication

- iii. Bradycardia (heart rate <50 beats per minute at rest) by
electrocardiogram (ECG) or pulse

- iv. On screening, inability to determine the corrected QT interval using
Fridericia's formula (QTcF) on the ECG (i.e., unreadable or not
interpretable) or QTcF >450 msec for males and >460 msec for females
(determined by mean of triplicate ECGs at screening)

10. Known hypersensitivity to the study drugs or their components

11. Pregnant or breast-feeding women

12. Concurrent participation in another clinical trial

1. Subjects must agree not to participate in another clinical trial at any time
during participation in VIKTORIA-1.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
30/09/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/09/2026
Actual
Sample size
Target
701
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Adelaide Oncology & Haematology - Adelaide
Recruitment hospital [2] 0 0
Peninsula & South Eastern Hematology and Oncology Group (PSEHOG) - Frankston
Recruitment hospital [3] 0 0
St Vincent's Hospital (Melbourne) Ltd - Melbourne
Recruitment hospital [4] 0 0
Hollywood Private Hospital, Breast Cancer Research Centre - Nedlands
Recruitment hospital [5] 0 0
Mater Hospital Brisbane, Mater Cancer Care Centre - South Brisbane
Recruitment hospital [6] 0 0
Icon Cancer Centre- Southport - Southport
Recruitment hospital [7] 0 0
Sydney Adventist Hospital - Wahroonga
Recruitment hospital [8] 0 0
The Queen Elizabeth Hospital - Woodville
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Frankston
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment postcode(s) [4] 0 0
- Nedlands
Recruitment postcode(s) [5] 0 0
- South Brisbane
Recruitment postcode(s) [6] 0 0
- Southport
Recruitment postcode(s) [7] 0 0
- Wahroonga
Recruitment postcode(s) [8] 0 0
- Woodville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
Nebraska
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Virginia
Country [18] 0 0
United States of America
State/province [18] 0 0
Washington
Country [19] 0 0
Argentina
State/province [19] 0 0
Buenos Aires
Country [20] 0 0
Argentina
State/province [20] 0 0
Córdoba
Country [21] 0 0
Argentina
State/province [21] 0 0
Pergamino
Country [22] 0 0
Argentina
State/province [22] 0 0
Rosario
Country [23] 0 0
Argentina
State/province [23] 0 0
San Juan
Country [24] 0 0
Argentina
State/province [24] 0 0
San Miguel De Tucumán
Country [25] 0 0
Brazil
State/province [25] 0 0
Itajaí
Country [26] 0 0
Brazil
State/province [26] 0 0
São Paulo
Country [27] 0 0
Mexico
State/province [27] 0 0
Mexico City
Country [28] 0 0
Mexico
State/province [28] 0 0
Monterrey
Country [29] 0 0
Mexico
State/province [29] 0 0
Morelia
Country [30] 0 0
Mexico
State/province [30] 0 0
Querétaro
Country [31] 0 0
Mexico
State/province [31] 0 0
Saltillo
Country [32] 0 0
Mexico
State/province [32] 0 0
San Pedro Garza Garcia
Country [33] 0 0
Singapore
State/province [33] 0 0
Singapore

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Celcuity, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety
of gedatolisib plus fulvestrant with or without palbociclib for the treatment of patients
with locally advanced or metastatic HR+/HER2- breast cancer following progression on or after
CDK4/6 and aromatase inhibitor therapy.

Condition or disease:

Breast Cancer

Intervention/treatment:

Drug: Gedatolisib

Drug: Palbociclib

Drug: Fulvestrant

Drug: Alpelisib

Phase 3
Trial website
https://clinicaltrials.gov/show/NCT05486143
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Nadene Zack
Address 0 0
Celcuity, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Nadene Zack
Address 0 0
Country 0 0
Phone 0 0
844-310-3900
Fax 0 0
Email 0 0
nzack@celcuity.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/show/NCT05486143