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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-503846-30-00 | Registry Identifier | EU CTIS | |
| 2023-000072-35 | EudraCT Number |
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| Name | Class |
|---|---|
| Berlin-Chemie AG Menarini Group | INDUSTRY |
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This is an international, multisite, open-label, Phase 1b/2 study, to confirm safety and efficacy of samuraciclib in combination with elacestrant in adult participants with metastatic or locally advanced Hormone Receptor (HR) positive and Human Epidermal Growth Factor Receptor (HER)2-negative breast cancer.
This is a multiple cohort study, an initial dose escalation phase is designed to confirm the safe dose of samuraciclib in combination with elacestrant. A Safety Review Committee (SRC) will monitor the safety, tolerability, and PK data during this phase. Once ascertained, an expansion cohort will be opened to explore the efficacy of samuraciclib in combination with elacestrant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Up to 6 evaluable participants will receive samuraciclib 240 mg in combination with elacestrant 300 mg in cycles of 28 days (Cycle 1 to 6), 56 days (Cycle 7 to 9) and up to 84 days (Cycles 10 onwards). |
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| Cohort 2 | Experimental | Up to 6 evaluable participants will receive samuraciclib in combination with elacestrant at the SRC recommended dose (anticipated 360mg samuraciclib, 300 mg elacestrant) in cycles of 28 days (Cycle 1 to 6), 56 days (Cycle 7 to 9) and up to 84 days (Cycles 10 onward). |
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| Cohort 3 | Experimental | Up to 6 evaluable participants will receive samuraciclib in combination with elacestrant at the SRC recommended dose (anticipated 360mg samuraciclib, 400 mg elacestrant) in cycles of 28 days (Cycle 1 to 6), 56 days (Cycle 7 to 9) and up to 84 days (Cycles 10 onward). |
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| Cohort 4 Expansion | Experimental | Up to 30 evaluable participants will receive samuraciclib in combination with elacestrant at the SRC recommended dose (anticipated 360mg samuraciclib, 400 mg elacestrant) in cycles of 28 days (Cycle 1 to 6), 56 days (Cycle 7 to 9) and up to 84 days (Cycles 10 onward). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Samuraciclib | Drug | Samuraciclib capsules by mouth once a day |
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| Measure | Description | Time Frame |
|---|---|---|
| Phase 1b (Dose-finding) | Identification of Samuraciclib + Elacestrant combination, Phase 2, expansion dose level. Incidence and severity of adverse events as graded by the National Cancer Institute Common Terminology Criteria for Adverse events (NCI-CTCAE) v5.0. Safety will be assessed by monitoring treatment - emerged severe and dose limiting adverse events and clinically relevant changes in vital signs and clinical laboratory results | From the date of first dose of any study intervention (Day 1 Cycle 1) and through 28 days after the last dose of any study intervention |
| Phase 2 (Expansion) | Progression Free Survival (PFS) is defined as the time from the date of first dose of IMP (Cycle 1 Day 1) to the date of the first documentation of objective progressive disease (PD) or death due to any cause, whichever occurs first. | From the date of first dose of any study intervention (Cycle 1 Day 1) until the first documentation of disease progression, death, withdrawal of consent, or start of new anticancer therapy (assessed up to week 48) |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-Emergent Adverse Events and Laboratory Abnormalities (Safety and Tolerability) | Type, incidence, severity (as graded by CTCAE v5.0), seriousness and relationship to study medications of AEs and any laboratory abnormalities. Safety will be assessed by monitoring adverse events and clinically relevant changes in vital signs and clinical laboratory results. | From the date of first dose of any study intervention through 28 days after the last dose of any study intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 38 - Northwestern University, Feinberg School of Medicine, Northwestern University | Chicago | Illinois | 60611 | United States | ||
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| Elacestrant Dihydrochloride | Drug | Elacestrant tablets by mouth once a day |
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| 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 enrolment until disease progression, or death due to any cause. | From the date of first dose of any study intervention (Cycle 1 Day 1) to ≥ 24 weeks or until disease progression or death to any cause (assessed up to week 24) |
| Overall response rate (ORR) | ORR is defined as the proportion of participants with a reduction in tumor burden with CR or PR according to RECIST version 1.1. ORR will be estimated for participants who received at least 1 dose of IMP, had measurable disease at baseline and had a postbaseline tumor assessment. | the date of first dose of study intervention (Cycle 1 Day 1) until the first documentation of disease progression, death, withdrawal of consent, or start of new anticancer therapy (assessed up to week 48) |
| Duration of Response (DOR) | DOR is 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 | From the date of first dose of study intervention (Cycle 1 Day 1) until the first documentation of disease progression, death, withdrawal of consent, or start of new anticancer therapy (assessed up to week 48) |
| Best percent change in tumor size. | Best percent change in tumor size is defined as the percentage change in the sum of the longest diameters of target lesions | From the date of first dose of study intervention (Cycle 1 Day 1) until the first documentation of disease progression, death, withdrawal of consent, or start of new anticancer therapy (assessed up to week 48) |
| Samuraciclib plasma exposure: Cmax | Plasma concentration for Samuraciclib | Day 1 of Cycles 1 and Cycle 2 (each cycle is 28 days) |
| Elacestrant exposure: Cmax | Plasma concentrations for Elacestrant | Day 1 of Cycles 1 and Cycle 2 (each cycle is 28 days) |
| Samuraciclib plasma exposure: Ctrough | Cycle 1 Day 2 and 15; Day 2 of Cycle 2; Day 1 of Cycles 3-6 and end of treatment within 28 days of last dose of IMP and prior to the initiation of a new anticancer therapy (each cycle is 28 days)] |
| Elacestrant exposure: Ctrough | Cycle 1 Day 2 and Day 15; Cycle 2 Day 2 of Cycle 2 and Day 1 of Cycles 3-6 and at end of treatment within 28 days of the last dose of IMP and prior to the initiation of a new anticancer therapy (each cycle is 28 days) |
| Genotyping for ESR1 and TP53 mutations | Genotyping for ESR1 and TP53 mutations to evaluate correlations between ESR1 and TP53 mutations and efficacy/safety findings | Screening |
| Site 42 - Dana-Farber Cancer Institute, EDDC |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| Site 35 - Cleveland Clinic, Taussig Cancer Institute | Cleveland | Ohio | 44106 | United States |
| Site 41 - The START Center for Cancer Care, South Texas Oncology and Hematology | San Antonio | Texas | 78229 | United States |
| Site 32 - Swedish Medical Center, Swedish Cancer Institute (SCI),Cherry Hill Campus | Seattle | Washington | 98122 | United States |
| Site 81 - Bergonie unicancer, Nouvelle-Aquitaine, L'Institut Bergonie | Bordeaux | France |
| Site 80 - Centre Jean Bernard, Clinique Victor Hugo | Le Mans | France |
| Site 83 - Institut Paoli Calmettes (IPC) | Marseille | France |
| Site 85 - Institut Curie | Paris | France |
| Site 82 - Institut de Cancerologie de Ouest (ICO) | Saint-Herblain | France |
| Site 65 - Complexo Hospitalario Universitario A Coruña | A Coruña | Spain |
| Site 64 - Hospital Clinic de Barcelona (Hospital Clinic i Provincial) | Barcelona | Spain |
| Site 68 -Hospital Universitario Vall d'Hebron | Barcelona | Spain |
| Site 61 - Institut Catala d'Oncologia (ICO), Hospital Duran i Reynals Location | L'Hospitalet de Llobregat | Spain |
| Site 62 - Universidad de Navarra, Clinica Universidad de Navarra (CUN) | Madrid | Spain |
| Site 63 - South Texas Accelerated Research Therapeutics, CIOCC, Hospital Madrid Norte-Sanchinarro | Madrid | Spain |
| Site 66 - Hospital Clinico San Carlos | Madrid | Spain |
| Site 69 - Universidad de Navarra - Clinica Universidad de Navarra (CUN) | Pamplona | Spain |
| Site 60 - NEXT Oncology EU Hospital Universitario Quiron Salud Madrid | Pozuelo de Alarcón | Spain |
| Site 67 - Universidad de Sevilla, Hospital Universitario Virgen Macarena | Seville | Spain |
| Site 12 - Belfast City Hospital | Belfast | United Kingdom |
| Site 4 - The Christie NHS Foundation Trust | Manchester | United Kingdom |
| Site 2 - Oxford University Hospitals NHS Trust - Churchill Hospital | Oxford | OX3 7LE | United Kingdom |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000626184 | RAD1901 |
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