Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Amgen | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
To evaluate the safety and tolerability of AMG 650 in adult participants and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Exploration Phase | Experimental | Participants will receive AMG 650 in 1 of 3 alternative schedules. The maximum tolerated dose (MTD) of each schedule will be estimated using isotonic regression (Ji et al, 2010). The Recommended Phase 2 Dose (RP2D) may be identified based on emerging safety, efficacy, and pharmacodynamics (PD) data prior to reaching an MTD. |
|
| Dose Expansion Phase Group 1: TNBC | Experimental | Participants with locally advanced or metastatic triple negative breast cancer (TNBC), will be administered with the preliminary RP2D identified from the dose exploration part of the study. |
|
| Dose Expansion Phase Group 2: HGSOC | Experimental | Participants with locally advanced or metastatic high grade serous ovarian cancer (HGSOC), will be administered with the preliminary RP2D identified from the dose exploration part of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMG 650 | Drug | AMG 650 administered orally as a tablet. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Dose Limiting Toxicities (DLTs) | Up to 12 months | |
| Number of Participants with Treatment-emergent Adverse Events (TEAEs) | Up to 24 months | |
| Number of Participants with Serious Adverse Events (SAEs) | Up to 24 months | |
| Number of Participants with Treatment-related Adverse Events | Up to 24 months | |
| Number of Participants Who Experience a Clinically Significant Change from Baseline in Vital Sign Measurement | Up to 24 months | |
| Number of Participants Who Experience a Clinically Significant Change from Baseline in Electrocardiogram (ECGs) Measurement | Up to 24 months | |
| Number of Participants Who Experience a Clinically Significant Change from Baseline in Clinical Laboratory Tests | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Up to 24 months | |
| Duration of Response (DOR) | Up to 24 months | |
| Progression-free Survival (PFS) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Angeles Clinic and Research Institute, West Los Angeles Office | Los Angeles | California | 90025 | United States | ||
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Up to 24 months |
| Clinical Benefit Rate (CBR) | Up to 24 months |
| Time to Response (TTR) | Up to 24 months |
| Time to Progression (TTP) | Up to 24 months |
| Overall Survival (OS) | Up to 24 months |
| Maximum Plasma Concentration (Cmax) of AMG 650 | Up to 24 months |
| Time to Maximum Plasma Concentration (Tmax) of AMG 650 | Up to 24 months |
| Area Under the Plasma Concentration-time Curve (AUC) Over the Dosing Interval for AMG 650 | Up to 24 months |
| Sarcoma Oncology Research Center LLC |
| Santa Monica |
| California |
| 90403 |
| United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Washington University | St Louis | Missouri | 63110-1093 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| Laura and Isaac Perlmutter Cancer Center at New York University Langone | New York | New York | 10016 | United States |
| Wake Forest University School of Medicine | Winston-Salem | North Carolina | 27157 | United States |
| Stephenson Cancer Center | Oklahoma City | Oklahoma | 73104 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| Texas Oncology - Baylor | Dallas | Texas | 75246 | United States |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| The Queen Elizabeth Hospital | Woodville South | South Australia | 5011 | Australia |
| Peter MacCallum Cancer Centre | Melbourne | Victoria | 3000 | Australia |
| Universitair Ziekenhuis Leuven - Campus Gasthuisberg | Leuven | 3000 | Belgium |
| Cross Cancer Institute | Edmonton | Alberta | T6G 1Z2 | Canada |
| Princess Margaret Cancer Centre | Toronto | Ontario | M5G 1Z5 | Canada |
| IRCCS Istituto Europeo di Oncologia | Milan | 20141 | Italy |
| Aichi Cancer Center | Nagoya | Aichi-ken | 464-8681 | Japan |
| National Cancer Center Hospital East | Kashiwa-shi | Chiba | 277-8577 | Japan |
| Hospital General Universitario Gregorio MaraƱon | Madrid | 28009 | Spain |
| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided