Register a trial

Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements. New passwords must include at least one lowercase letter, one uppercase letter, one number and one special character (e.g. !#$%&@).
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06726148




Registration number
NCT06726148
Ethics application status
Date submitted
5/12/2024
Date registered
10/12/2024

Titles & IDs
Public title
Study of ECI830 Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer and Other Advanced Solid Tumors
Scientific title
An Open-label, Multi-center, Phase I/II Study of ECI830 as a Single Agent and in Combination With Ribociclib and Endocrine Therapy in Patients With Advanced Hormone Receptor Positive, HER2-negative Breast Cancer and Advanced Solid Tumors
Secondary ID [1] 0 0
2024-517281-42
Secondary ID [2] 0 0
CECI830A12101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced HR+/HER2- Breast Cancer 0 0
Advanced CCNE1-amplified Solid Tumors 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ECI830
Treatment: Drugs - ribociclib
Treatment: Drugs - fulvestrant

Experimental: ECI830 Single Agent (Arm A) - Phase I

Experimental: Dose Escalation Combination ECI830 + ribociclib + fulvestrant (Arm B) - Phase I

Experimental: Ribociclib in combination with fulvestrant (Arm C) - Phase II

Experimental: ECI830 in combination with fulvestrant (Arm D) - Phase II

Experimental: ECI830 in combination with ribociclib and fulvestrant (Arm E) - Phase II

Experimental: ECI830 in combination with ribociclib and fulvestrant (Arm F) - Phase II


Treatment: Drugs: ECI830
Experimental

Treatment: Drugs: ribociclib
Approved medication

Treatment: Drugs: fulvestrant
Approved medication
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase I: Incidence of dose-limiting toxicities (DLTs)
Timepoint [1] 0 0
2 years
Primary outcome [2] 0 0
Phase I: Incidence of adverse events (AEs) and serious adverse events (SAEs)
Timepoint [2] 0 0
2 years
Primary outcome [3] 0 0
Phase I: Number of participants with dose interruptions, reductions and discontinuations
Timepoint [3] 0 0
2 years
Primary outcome [4] 0 0
Phase II: PFS rate at 6 months per local response evaluation criteria in solid tumors (RECIST) v1.1
Timepoint [4] 0 0
6 months
Secondary outcome [1] 0 0
Phase I and II: Area under the plasma concentration-time curve (AUC) of ECI830 and ribociclib
Timepoint [1] 0 0
From pre-dose up to 24 hours post-dose in Cycle 1. One cycle=28 days.
Secondary outcome [2] 0 0
Phase I and II: Maximum observed plasma concentration (Cmax) of ECI830 and ribociclib
Timepoint [2] 0 0
From pre-dose up to 24 hours post-dose in Cycle 1. One cycle=28 days.
Secondary outcome [3] 0 0
Phase I and II: Best overall response (BOR) per RECIST v1.1
Timepoint [3] 0 0
2 years
Secondary outcome [4] 0 0
Phase I and II: Overall response rate (ORR) per RECIST v1.1
Timepoint [4] 0 0
2 years
Secondary outcome [5] 0 0
Phase I and II: Disease control rate (DCR) per RECIST v1.1
Timepoint [5] 0 0
2 years
Secondary outcome [6] 0 0
Phase I and II: Clinical benefit rate (CBR) per RECIST v1.1
Timepoint [6] 0 0
2 years
Secondary outcome [7] 0 0
Phase I and II: Progression Free Survival (PFS) per RECIST v1.1
Timepoint [7] 0 0
2 years
Secondary outcome [8] 0 0
Phase II: Duration of Response (DOR) per RECIST v1.1
Timepoint [8] 0 0
2 years
Secondary outcome [9] 0 0
Phase II: Overall Survival (OS)
Timepoint [9] 0 0
2 years
Secondary outcome [10] 0 0
Phase II: Incidence of adverse events (AEs) and serious adverse events (SAEs)
Timepoint [10] 0 0
2 years
Secondary outcome [11] 0 0
Phase II: Number of participants with dose interruptions, reductions and discontinuations
Timepoint [11] 0 0
2 years

Eligibility
Key inclusion criteria
Age = 18 years old.

Patients with one of the following indications:

Phase I:

HR+/HER2- aBC with disease progression on or following at least one line of hormone-based therapy in combination with a CDK4/6i and at least one additional line of systemic therapy for metastatic disease.

Histologically and/or cytologically confirmed diagnosis of locally advanced or metastatic cancer with a CCNE1 amplification. For dose expansion only: no more than 3 prior lines of therapy for advanced or metastatic disease.

Phase II:

HR+/HER2- aBC with disease progression on an aromatase inhibitor or tamoxifen in combination with a CDK4/6 inhibitor for unresectable/metastatic disease with no more than 2 lines of endocrine therapy.

Measurable disease as determined by RECIST v1.1.

BC only: If no measurable disease is present, then at least one predominantly lytic bone lesion must be present that can be accurately assessed at baseline and is suitable for repeated assessment.
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous treatment with a CDK2 inhibitor at any time.

Patients with inadequate bone marrow and/or organ functions with out-of-range laboratory values.

Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality including MI, CABG, long QT syndrome, or risk factors for TdP.

Presence of symptomatic CNS metastases or CNS metastases that require local therapy or increasing doses of corticosteroids within 2 weeks prior to study entry.

For the combination treatment:

Patients with symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine-based therapy.

Patients who could not tolerate the prescribed dose of ribociclib during a previous course of treatment, requiring dose reduction or permanent discontinuation due to adverse events.

For patients with BC: Patient is concurrently using hormone replacement therapy.

WOCBP who are unwilling to use highly effective contraception methods, pregnant or nursing women.

Other protocol-defined inclusion/exclusion criteria may apply.

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
Single group
Other design features
Phase
Phase 1
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
Actual
3/04/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
25/09/2028
Actual
Sample size
Target
280
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Israel
State/province [1] 0 0
Haifa
Country [2] 0 0
Japan
State/province [2] 0 0
Tokyo
Country [3] 0 0
Singapore
State/province [3] 0 0
Singapore

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Country 0 0
Phone 0 0
1-888-669-6682
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06726148