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Report for Clinical Trial NCT03250676
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
The purpose of phase 1 is to determine safety, tolerability and pharmacokinetics (PK) of
H3B-6545 in women with locally advanced or metastatic estrogen receptor (ER)-positive, human
epidermal growth factor 2 (HER2)-negative breast cancer.
The purpose of phase 2 is to estimate the efficacy of H3B-6545 in terms of best overall
response rate, duration of response (DoR), clinical benefit rate (CBR), disease control rate
(DCR), progression-free survival (PFS), and overall survival (OS) in all participants with
ER-positive, HER2-negative breast cancer and in those with and without ER alpha mutation
[including a clonal estrogen receptor 1 gene (ESR1) Y537S mutation].
NCT03250676 Breast Neoplasms Breast Cancer Estrogen-receptor Positive Breast Cancer Cancer, Breast Breast Cancer Female Breast Adenocarcinoma Estrogen Receptor Positive Tumor ER ER Positive
1 Interventions
Name: H3B-6545
Description: Oral capsules by mouth once daily
Type: Drug
Group Labels: 2 H3B-6545 Arm 1: Dose escalation H3B-6545 Arm 2: Phase 2
Primary Outcomes
Measure: Number of Participants with Dose-limiting Toxicities (DLTs) Time: Phase 1 Cycle 1 (28 days)
Measure: Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Time: Phase 1 and 2 continuously throughout the study until 28 days after treatment discontinuation (up to 36 months)
Secondary Outcomes
Measure: Area under the Plasma Concentration-time Curve from Time 0 Through the Last Measurable Point (AUC0-t) of H3B-6545 Time: Phase 1, Cycle 1 (28-day cycles): Days 1 and 15 pre-dose and at multiple time points (up to 24 hours) post-dose; or Phase 2 Cycle 1 (28-day cycles): Days 15 or 22 pre-dose and at multiple time points (up to 24 hours) post-dose
Measure: Mean Maximum Observed Plasma Concentration (Cmax) of H3B-6545 Time: Phase 1, Cycle 1 (28-day cycles): Days 1 and 15 (pre-dose and at multiple time points (up to 24 hours) post-dose; or Phase 2 Cycle 1 (28-day cycles): Days 15 or 22 pre-dose and at multiple time points (up to 24 hours) post-dose
Measure: Time of Maximum Observed Plasma Concentration (tmax) of H3B-6545 Time: Phase 1, Cycle 1 (28-day cycles): Days 1 and 15 pre-dose and at multiple time points (up to 24 hours) post-dose; or Phase 2 Cycle 1 (28-day cycles): Days 15 or 22 pre-dose and at multiple time points (up to 24 hours) post-dose
Measure: Objective Response Rate (ORR) Time: Phase 1 and 2 up to approximately 36 months
Measure: Duration of Response (DoR) Time: Phase 1 and 2 up to approximately 36 months
Measure: Disease Control Rate (DCR) Time: Phase 1 and 2 up to approximately 36 months
Measure: Clinical Benefit Rate (CBR) Time: Phase 1 and 2 up to approximately 36 months
Measure: Progression-free survival (PFS) Time: Phase 1 and 2 up to approximately 36 months
Measure: Overall Survival (OS) Time: Phase 1 and 2 up to approximately 36 months
Purpose: Treatment
Allocation: Non-Randomized
Parallel Assignment
There are 2 SNPs
SNPs
8. Participants under amendment 6 must have ESR1 Y537S mutation in absence of ESR1 D538G
mutation as per the results of a central laboratory. --- Y537S --- --- D538G ---
The purpose of phase 2 is to estimate the efficacy of H3B-6545 in terms of best overall
response rate, duration of response (DoR), clinical benefit rate (CBR), disease control rate
(DCR), progression-free survival (PFS), and overall survival (OS) in all participants with
ER-positive, HER2-negative breast cancer and in those with and without ER alpha mutation
[including a clonal estrogen receptor 1 gene (ESR1) Y537S mutation]. --- Y537S ---
8. Participants under amendment 6 must have ESR1 Y537S mutation in absence of ESR1 D538G
mutation as per the results of a central laboratory. --- Y537S ---