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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03250676
Other study ID # H3B-6545-A001-101
Secondary ID 2018-000570-29
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date August 17, 2017
Est. completion date October 26, 2023

Study information

Verified date March 2023
Source Eisai Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary purpose of phase 1 portion of this study is to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of H3B-6545 in women with locally advanced or metastatic estrogen receptor (ER)-positive, human epidermal growth factor 2 (HER2)-negative breast cancer. The primary purpose of phase 2 portion of this study 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).


Recruitment information / eligibility

Status Completed
Enrollment 206
Est. completion date October 26, 2023
Est. primary completion date October 26, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Pre- or post-menopausal women. 2. ER-positive, HER2-negative breast cancer that is advanced or metastatic. 3. Progressed on prior therapy. Multiple prior lines of therapy allowed in Phase 1 and 2. Participants under amendment 6 (or subsequent amendments) must have received prior cyclin-dependent kinase (CDK4/6) inhibitor therapy. Up to one prior chemotherapy in the metastatic setting is allowed. 4. A recent archival tumor tissue obtained within 6 months prior to enrollment or a fresh tumor biopsy must be provided. A second biopsy after initiating trial therapy is not required. 5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. 6. Adequate bone marrow and organ function. 7. Participants under amendment 6 (or subsequent amendments) must have measurable disease at baseline as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. 8. Participants under amendment 6 (or subsequent amendments) must have ESR1 Y537S mutation in absence of ESR1 D538G mutation as per the results of a central laboratory from a Nucleic Acids Whole Blood sample. Exclusion Criteria: 1. Participants must have at least one measurable lesion. 2. Participant with inflammatory breast cancer. 3. Participant has received more than one prior chemotherapy regimen for metastatic disease (Phase 2 only). 4. Females of childbearing potential who are unable or unwilling to follow adequate contraceptive measures.

Study Design


Intervention

Drug:
H3B-6545
Oral capsules by mouth once daily

Locations

Country Name City State
France Edog - Ico - Ppds Angers
France Hopital Jean Minjoz Besançon
France Centre Jean Perrin Clermont-Ferrand
France Centre Oscar Lambret Lille
France Hôpital de la Pitié Salpétrière Paris
France Hôpital Saint Louis Paris
France EDOG - Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer - PPDS Rennes
France EDOG Institut de Cancerologie de l'Ouest - PPDS St. Herblain
France Institut de Cancérologie Strasbourg Europe Strasbourg
France Institut Gustave Roussy Villejuif Cedex
United Kingdom Velindre Cancer Centre Cardiff
United Kingdom The Royal Marsden NHS Foundation Trust Chelsea London
United Kingdom Barts Health NHS Trust London
United Kingdom Sarah Cannon Research Institute London
United Kingdom Christie Hospital Manchester
United Kingdom The Royal Marsden NHS Foundation Trust Sutton
United States University of Michigan Ann Arbor Michigan
United States University of Colorado - Cancer Center Aurora Colorado
United States Johns Hopkins Sidney Kimmel Comprehensive Cancer Center Baltimore Maryland
United States Massachusetts General Hospital Boston Massachusetts
United States University of North Carolina Chapel Hill North Carolina
United States Parkland Health and Hospital System Dallas Texas
United States UT Southwestern Medical Center Dallas Texas
United States Holy Cross Hospital Inc Fort Lauderdale Florida
United States Florida Cancer Specialists South Fort Myers Florida
United States Western Regional Medical Center, Inc., DBA Cancer Treatment Centers of America, Phoenix Goodyear Arizona
United States Research Medical Center Kansas City Missouri
United States Saint Luke's Cancer Institute Kansas City Missouri
United States Comprehensive Cancer Center of Nevada Las Vegas Nevada
United States University of California Los Angeles Los Angeles California
United States Tennessee Oncology Nashville Tennessee
United States Southeastern Regional Medical Center, Inc., DBA Cancer Treatment Centers of America, Atlanta Newnan Georgia
United States Florida Cancer Specialists North Saint Petersburg Florida
United States Huntsman Cancer Institute at The University of Utah Salt Lake City Utah
United States University of California San Francisco San Francisco California
United States Florida Cancer Specialists and Research Institute Sarasota Florida
United States Tyler Oncology/Oncology PA Tyler Texas
United States Carle Cancer Center Urbana Illinois
United States Midwestern Regional Medical Center, Inc., DBA Cancer Treatment Centers of Americal, Chicago Zion Illinois

Sponsors (1)

Lead Sponsor Collaborator
Eisai Inc.

Countries where clinical trial is conducted

United States,  France,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants with Dose-limiting Toxicities (DLTs) Phase 1 Cycle 1 (28 days)
Primary Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Phase 1 and 2 continuously throughout the study until 28 days after treatment discontinuation (up to 36 months)
Secondary Area under the Plasma Concentration-time Curve from Time 0 Through the Last Measurable Point (AUC0-t) of H3B-6545 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
Secondary Mean Maximum Observed Plasma Concentration (Cmax) of H3B-6545 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
Secondary Time of Maximum Observed Plasma Concentration (tmax) of H3B-6545 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
Secondary Objective Response Rate (ORR) Phase 1 and 2 up to approximately 36 months
Secondary Duration of Response (DoR) Phase 1 and 2 up to approximately 36 months
Secondary Disease Control Rate (DCR) Phase 1 and 2 up to approximately 36 months
Secondary Clinical Benefit Rate (CBR) Phase 1 and 2 up to approximately 36 months
Secondary Progression-free survival (PFS) Phase 1 and 2 up to approximately 36 months
Secondary Overall Survival (OS) Phase 1 and 2 up to approximately 36 months
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