Back to resultsA Study of Samuraciclib in Combination With Fulvestrant in Metastatic or Locally Advanced Breast Cancer in Adult Participants (SUMIT-BC)
Primary Purpose
Metastatic Breast Cancer, Locally Advanced Breast Cancer, Breast Cancer
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Samuraciclib
Fulvestrant
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Breast Cancer focused on measuring Metastatic Breast Cancer, Advanced Breast Cancer, Breast Cancer, HR Positive, HER2-Negative
Eligibility Criteria
Inclusion Criteria: Histologically confirmed diagnosis of ER-positive, HER2-negative locally advanced or metastatic breast cancer. Documented objective disease progression while on or within 6 months after the end of the most recent therapy. Received prior AI in combination with a CDK4/6i as the last therapy Known TP53 mutation status. Participants must have measurable disease or bone only disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Pre/peri-menopausal participants must have commenced treatment with a luteinizing hormone-releasing hormone (LHRH) agonist at least 4 weeks prior to first dose of study intervention. Eastern Cooperative Oncology Group (ECOG) performance status ≤1 with no deterioration over the past 2 weeks. Expected life expectancy of >12 weeks in the judgement of the treating investigator. Exclusion Criteria: Inflammatory breast cancer. Participants with any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix. More than 1 line of endocrine treatment for locally advanced or metastatic disease treatment. Inadequate hepatic, renal, and bone marrow function. Clinically significant cardiovascular disease. Any current or prior central nervous system metastases, carcinomatous meningitis, or leptomeningeal disease. Pregnant or breastfeeding women.
Sites / Locations
- Ocala Oncology Center PL DBA Florida Cancer AffiliatesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Arm A
Arm B
Arm C
Arm Description
Participants will receive 360 mg of samuraciclib on cycles of 28 days (Cycle 1 to 6), 56 days (Cycle 7 to 9) and up to 84 days (Cycles 10 onwards in combination with fulvestrant administered monthly, plus an additional dose at Cycle 1 Day 15.
Participants will receive 240 mg of samuraciclib on cycles of 28 days (Cycle 1 to 6), 56 days (Cycle 7 to 9) and up to 84 days (Cycles 10 onwards in combination with fulvestrant administered monthly, plus an additional dose at Cycle 1 Day 15.
Participants will receive fulvestrant administered monthly, plus additional dose at Cycle 1 Day 15.
Outcomes
Primary Outcome Measures
Clinical Benefit Response (CBR)
CBR is defined as the overall complete response (CR), partial response (PR), or stable disease (SD) ≥ 24 weeks according to RECIST version 1.1 recorded from randomization until disease progression, or death due to any cause.
Secondary Outcome Measures
Objective Response Rate (ORR)
ORR defined as the proportion of participants who achieved a best overall Response (BOR) of CR or PR per RECIST Version 1.1 from randomization until disease progression, or death due to any cause.
Duration of Response (DOR)
DOR defined as the time from the date of first documentation of objective tumor response (CR or PR) to the earliest documented disease progression per RECIST version 1.1, or death due to any cause.
Progression Free Survival (PFS)
PFS defined as the time from the date of randomization to the earliest documented disease progression per RECIST version 1.1, or death due to any cause.
Incidence and severity of adverse events (AEs) as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0
Safety will be assessed by monitoring adverse events and clinically relevant changes in vital signs and clinical laboratory results.
Samuraciclib plasma exposure: Cmax
Samuraciclib plasma exposure: Ctrough
Fulvestrant plasma exposure: Ctrough
Full Information
NCT ID
NCT05963984
First Posted
June 30, 2023
Last Updated
September 6, 2023
Sponsor
Carrick Therapeutics Limited
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT05963984
Brief Title
A Study of Samuraciclib in Combination With Fulvestrant in Metastatic or Locally Advanced Breast Cancer in Adult Participants
Acronym
SUMIT-BC
Official Title
An Open-label, Interventional, Multicenter, Randomized, Phase 2 Study of Fulvestrant With or Without Samuraciclib in Participants With Metastatic or Locally Advanced Hormone Receptor (HR) Positive and Human Epidermal Growth Factor Receptor (HER)2-Negative Breast Cancer (BC)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2023 (Anticipated)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
June 16, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Carrick Therapeutics Limited
Collaborators
Pfizer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of samuraciclib in combination with fulvestrant versus fulvestrant alone in adult participants with metastatic or locally advanced Hormone Receptor (HR) positive and Human Epidermal Growth Factor Receptor (HER)2-negative breast cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer, Locally Advanced Breast Cancer, Breast Cancer
Keywords
Metastatic Breast Cancer, Advanced Breast Cancer, Breast Cancer, HR Positive, HER2-Negative
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm A
Arm Type
Experimental
Arm Description
Participants will receive 360 mg of samuraciclib on cycles of 28 days (Cycle 1 to 6), 56 days (Cycle 7 to 9) and up to 84 days (Cycles 10 onwards in combination with fulvestrant administered monthly, plus an additional dose at Cycle 1 Day 15.
Arm Title
Arm B
Arm Type
Experimental
Arm Description
Participants will receive 240 mg of samuraciclib on cycles of 28 days (Cycle 1 to 6), 56 days (Cycle 7 to 9) and up to 84 days (Cycles 10 onwards in combination with fulvestrant administered monthly, plus an additional dose at Cycle 1 Day 15.
Arm Title
Arm C
Arm Type
Experimental
Arm Description
Participants will receive fulvestrant administered monthly, plus additional dose at Cycle 1 Day 15.
Intervention Type
Drug
Intervention Name(s)
Samuraciclib
Intervention Description
Samuraciclib tablet by mouth once a day
Intervention Type
Drug
Intervention Name(s)
Fulvestrant
Other Intervention Name(s)
Faslodex
Intervention Description
Injection administered monthly (i.e., every 4 weeks), plus additional dose at Cycle 1 Day 15
Primary Outcome Measure Information:
Title
Clinical Benefit Response (CBR)
Description
CBR is defined as the overall complete response (CR), partial response (PR), or stable disease (SD) ≥ 24 weeks according to RECIST version 1.1 recorded from randomization until disease progression, or death due to any cause.
Time Frame
From randomization until Week 24
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
ORR defined as the proportion of participants who achieved a best overall Response (BOR) of CR or PR per RECIST Version 1.1 from randomization until disease progression, or death due to any cause.
Time Frame
Time from the date of first dose of study intervention until the first documentation of disease progression, death, withdrawal of consent, or start of new anticancer therapy (assessed up to week 48)
Title
Duration of Response (DOR)
Description
DOR defined as the time from the date of first documentation of objective tumor response (CR or PR) to the earliest documented disease progression per RECIST version 1.1, or death due to any cause.
Time Frame
Time from the date of first dose of study intervention until the first documentation of disease progression, death, withdrawal of consent, or start of new anticancer therapy (assessed up to week 48)
Title
Progression Free Survival (PFS)
Description
PFS defined as the time from the date of randomization to the earliest documented disease progression per RECIST version 1.1, or death due to any cause.
Time Frame
Time from the date of first dose of study intervention until the first documentation of disease progression, death, withdrawal of consent, or start of new anticancer therapy (assessed up to week 48)
Title
Incidence and severity of adverse events (AEs) as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0
Description
Safety will be assessed by monitoring adverse events and clinically relevant changes in vital signs and clinical laboratory results.
Time Frame
From first dose of any study intervention through 28 days after the last dose of any study intervention
Title
Samuraciclib plasma exposure: Cmax
Time Frame
Day 1 of Cycles 2 and 3 (each cycle is 28 days)
Title
Samuraciclib plasma exposure: Ctrough
Time Frame
Cycle 1 Days 8 and 15; Day 1 of Cycles 2, 3, 4, 5, and 6; and within 28 days of last dose (each cycle is 28 days)
Title
Fulvestrant plasma exposure: Ctrough
Time Frame
Cycle 1 Days 8 and 15; Day 1 of Cycles 2, 3, 4, 5 and 6; and within 28 days of last dose (each cycle is 28 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed diagnosis of ER-positive, HER2-negative locally advanced or metastatic breast cancer.
Documented objective disease progression while on or within 6 months after the end of the most recent therapy.
Received prior AI in combination with a CDK4/6i as the last therapy
Known TP53 mutation status.
Participants must have measurable disease or bone only disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Pre/peri-menopausal participants must have commenced treatment with a luteinizing hormone-releasing hormone (LHRH) agonist at least 4 weeks prior to first dose of study intervention.
Eastern Cooperative Oncology Group (ECOG) performance status ≤1 with no deterioration over the past 2 weeks.
Expected life expectancy of >12 weeks in the judgement of the treating investigator.
Exclusion Criteria:
Inflammatory breast cancer.
Participants with any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.
More than 1 line of endocrine treatment for locally advanced or metastatic disease treatment.
Inadequate hepatic, renal, and bone marrow function.
Clinically significant cardiovascular disease.
Any current or prior central nervous system metastases, carcinomatous meningitis, or leptomeningeal disease.
Pregnant or breastfeeding women.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Operations
Phone
+353 1 5996873
Email
hello@carricktherapeutics.com
Facility Information:
Facility Name
Ocala Oncology Center PL DBA Florida Cancer Affiliates
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of Samuraciclib in Combination With Fulvestrant in Metastatic or Locally Advanced Breast Cancer in Adult Participants
We'll reach out to this number within 24 hrs