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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-000272-95 | EudraCT Number |
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| Name | Class |
|---|---|
| Seragon Pharmaceuticals | UNKNOWN |
This is an open-label, dose-finding, safety, pharmacokinetics (PK), and evidence-of-activity study of GDC-0927 in postmenopausal women with locally advanced or metastatic Estrogen Receptor Positive (ER+) Human Epidermal Growth Factor Receptor 2 (HER2) breast cancer. The study will be conducted in two parts: Dose escalation and Dose expansion. During dose escalation, GDC-0927 will be administered orally as a single dose on Day -7 for PK evaluation during the lead-in period. Depending on safety and tolerability, participants will be assigned sequentially to escalating doses of GDC-0927 using standard 3+3 design. During dose expansion, there will be no PK week lead-in period. All participants will be treated until disease progression, unacceptable toxicity, participant withdrawal of consent or study termination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part I: Dose Escalation - GDC-0927 | Experimental | Participants will receive GDC-0927 orally as a single dose on Day -7. Continuous daily dosing will commence on Day 1. Depending on safety and tolerability, participants will be assigned sequentially to escalating doses of GDC-0927 with use of a standard 3 + 3 design. The starting dose will be 600 milligrams per day (mg/day), followed by dose escalation in 400 milligrams (mg) increments. |
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| Part II: Dose Expansion - GDC-0927 | Experimental | Participants in the expansion cohorts will receive GDC-0927 at MTD/RP2D starting from Day 1 of Cycle 1 (cycle length: 28 days) up to disease progression, unacceptable toxicity, participant withdrawal of consent or study termination. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GDC-0927 | Drug | GDC-0927 will be administered as per schedule specified in the respective arm. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD)/Recommended Phase II Dose (RP2D) of GDC-0927 | Day-7 through Cycle 1 (cycle length: 28 days) | |
| Percentage of Participants With Adverse Events (AEs) | From screening up to approximately 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Objective Response Assessed by Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1) | At screening, every 8 weeks from Cycle 1 (each cycle: 28 days) up to end of treatment (up to approximately 3 years) | |
| Percentage of Participants With Clinical Benefit Assessed by RECIST v1.1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital. | Boston | Massachusetts | 02114 | United States | ||
| Dana Farber Cancer Institute |
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| At screening, every 8 weeks from Cycle 1 (each cycle: 28 days) up to end of treatment (up to approximately 3 years) |
| Part I: Maximum Observed Plasma Concentration (Cmax) of GDC-0927 | Pre-dose (0 hour [hr]), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24 hrs post-dose on Day -7; Days -5, -4, -3; pre-dose (0 hr) on Day 1 Cycle 1; pre-dose (0 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-dose on Day 1 Cycle 2 (cycle length: 28 days) |
| Part II: Cmax of GDC-0927 | Pre-dose (0 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24 hrs post-dose on Day 1 Cycle 1; pre-dose (0 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-dose on Day 1 Cycle 2 (each cycle: 28 days) |
| Part I: Time to Reach Cmax (Tmax) of GDC-0927 | Pre-dose (0 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24 hrs post-dose on Day -7; Days -5, -4, -3; pre-dose (0 hr) on Day 1 Cycle 1; pre-dose (0 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-dose on Day 1 Cycle 2 (cycle length: 28 days) |
| Part II: Tmax of GDC-0927 | Pre-dose (0 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24 hrs post-dose on Day 1 Cycle 1; pre-dose (0 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-dose on Day 1 Cycle 2 (each cycle: 28 days) |
| Part I: Area Under the Plasma Concentration Versus Time Curve (AUC) of GDC-0927 | Pre-dose (0 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24 hrs post-dose on Day -7; Days -5, -4, -3; pre-dose (0 hr) on Day 1 Cycle 1; pre-dose (0 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-dose on Day 1 Cycle 2 (cycle length: 28 days) |
| Part II: AUC of GDC-0927 | Pre-dose (0 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24 hrs post-dose on Day 1 Cycle 1; pre-dose (0 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-dose on Day 1 Cycle 2 (each cycle: 28 days) |
| Plasma Half-Life (t1/2) of GDC-0927 | Pre-dose (0 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24 hrs post-dose on Day -7; Days -5, -4, -3; pre-dose (0 hr) on Day 1 Cycle 1 (cycle length: 28 days) |
| Part II: t1/2 of GDC-0927 | Pre-dose (0 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24 hrs post-dose on Day 1 Cycle 1 (each cycle: 28 days) |
| Part I: Change From Baseline in Corrected QT (QTc) Interval Using Fridericia's Formula, as Assessed by Electrocardiogram (ECG) | Screening (baseline); Days -7, -5, -4, -3; Cycle 2 Day 1; end of treatment (up to approximately 3 years) (each cycle = 28 days) |
| Part II: Change From Baseline in QTc Interval Using Fridericia's Formula, as Assessed by ECG | Screening (baseline); Cycle 1 Day 1; Cycle 2 Day 1; end of treatment (up to approximately 3 years) (each cycle = 28 days) |
| Part I: Change From Baseline in RR Interval, as Assessed by ECG | Screening (baseline); Days -7, -5, -4, -3; Cycle 2 Day 1; end of treatment (up to approximately 3 years) (each cycle = 28 days) |
| Part II: Change From Baseline in RR Interval, as Assessed by ECG | Screening (baseline); Cycle 1 Day 1; Cycle 2 Day 1; end of treatment (up to approximately 3 years) (each cycle = 28 days) |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Sarah Cannon Cancer Center | Germantown | Tennessee | 38138 | United States |
| Vanderbilt Ingram Cancer Ctr | Nashville | Tennessee | 37232 | United States |
| ICO I Hospitalet Hospital Duran i Reynals Instituto Catalan de Oncologia de Hospitalet ICO | L'Hospitalet de Llobregat | Barcelona | 08908 | Spain |
| Onkologikoa - Kutxaren Institutu Onkologikoa | Donostia / San Sebastian | Guipuzcoa | 20014 | Spain |
| Hospital Univ Vall d'Hebron; Servicio de Oncologia | Barcelona | 08035 | Spain |
| MD Anderson Cancer Center Madrid - España; Servicio de Farmacia | Madrid | 28033 | Spain |
| Hospital Universitario Ramón y Cajal | Madrid | 28034 | Spain |
| Hospital General Universitario Gregorio Maranon | Madrid | 28040 | Spain |
| HM Sanchinarro - CIOCC | Madrid | 28050 | Spain |
| Hospital Clinico Universitario de Valencia | Valencia | 46010 | Spain |
| 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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