Phase 1b/2 Open-label Study of Samuraciclib in Combination with Elacestrant in Breast Cancer
Research type
Research Study
Full title
A Phase 1b/2 Open-label Study of Samuraciclib in Combination with Elacestrant in Participants with Metastatic or Locally Advanced Hormone Receptor-positive and Human Epidermal Growth Factor Receptor 2-negative Breast Cancer
IRAS ID
1007994
Contact name
Sheila O'Mahony
Contact email
Sponsor organisation
Carrick Therapeutics Limited
Eudract number
2023-000072-35
Research summary
This is a 4 Cohort study designed to confirm the safe dose of samuraciclib in combination with elacestrant. The primary objective of this study for Phase 1b is to determine the recommended dose (RP2D) of samuraciclib and elacestrant in combination for Phase 2. The primary objective of this study for Ph2 is to assess the efficacy of samuraciclib and elacestrant in combination in terms of progression-free survival (PFS) as per local investigator assessment.
The combination of samuraciclib and elacestrant is considered experimental. In this document, the term ‘study drug’ refers to samuraciclib combined with elacestrant.
The total duration of participation will depend on how the patient responds to the study drug and may continue until their disease gets worse, they develop bad side effects, decide to no longer take part, the doctor decides that stopping the study drug is in their best interest, or the study ends.
The study will include two parts as described below. Patients will only be enrolled to one part of the study.
Part 1 (Dose Finding) - Groups of patients will receive different doses of study drug to determine which dose is the safest and most tolerable, and to determine the recommended dose to be given to patients in Part 2.Part 2 (Dose Expansion) - Patients will receive the recommended dose of study drug that was determined to be safe and tolerable during Part 1. This part of the study will continue to evaluate the safety and tolerability of study drug in additional patients at the dose selected during Part 1 and will also determine the effectiveness of that recommended dose.
Patients will visit the study hospital for the following visits:
Screening Visit
Cycle 1, Day 1, 2 & 15
Cycle 2, Day 1, 2 & 15
Cycles 3-6, Day 1
Cycles 7-9, Day 1
Cycles 10 onwards, Day 1
End of Treatment Visit (28 days after last dose of the study drug)
Follow-up Visits
Imaging for cancer assessment (8 weeks from C1-D1 to Week 48. Thereafter, every 12 weeks.)REC name
London - West London & GTAC Research Ethics Committee
REC reference
23/LO/0523
Date of REC Opinion
19 Oct 2023
REC opinion
Further Information Favourable Opinion