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| ID | Type | Description | Link |
|---|---|---|---|
| C4251016 | Other Identifier | Alias Study Number | |
| 7119-002 | Other Identifier | Alias Study Number |
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The primary purpose of this study is to characterize the safety and tolerability of tucatinib (MK-7119) in Chinese participants with human epidermal growth factor receptor 2 positive (HER2+) advanced breast cancer, gastric or gastroesophageal junction adenocarcinoma (GEC), and colorectal cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tucatinib Treatment | Experimental | Chinese participants with HER2+ advanced breast cancer, gastric or gastroesophageal junction adenocarcinoma, or colorectal cancer receive tucatinib 300 mg by mouth twice daily during 21-day cycles. Treatment continues until there is evidence of unacceptable toxicity or documented progression. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tucatinib | Drug | Tucatinib 150 mg and 50 mg tablets taken by mouth at a dose of 300 mg twice daily. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with ≥1 adverse event (AE) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | Up to approximately 2.5 years |
| Percentage of participants discontinuing from study therapy due to AE | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | Up to approximately 2.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) of first dose of tucatinib | The Cmax of tucatinib will be determined after the first dose. | Cycle 1, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose |
| Time of maximum plasma concentration (Tmax) of first dose of tucatinib |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harbin Medical University Cancer Hospital | Harbin | Heilongjiang | 150081 | China | ||
| Hunan Cancer Hospital |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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The Tmax of tucatinib will be determined after the first dose. |
| Cycle 1, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose |
| Area under the plasma concentration time curve from dosing to 12 hours postdose (AUC0-12) of first dose of tucatinib | The AUC0-12 of tucatinib will be determined after the first dose. | Cycle 1, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose |
| Apparent plasma half-life (t½) of first dose of tucatinib | The t½ of tucatinib will be determined after the first dose. | Cycle 1, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose |
| Apparent clearance (CL/F) of first dose of tucatinib | The CL/F of tucatinib will be determined after the first dose. | Cycle 1, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose |
| Volume of distribution (Vz/F) of first dose of tucatinib | The Vz/F of tucatinib will be determined after the first dose. | Cycle 1, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose |
| Trough concentration (Ctrough) of tucatinib at steady state | The Ctrough of tucatinib will be determined at steady state. | Cycle 1, Days 8 and 15: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose |
| Accumulation ratio of tucatinib at steady state | The accumulation ratio of tucatinib will be determined at steady state. | Cycle 2, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose |
| Cmax at steady state (Cmaxss) of tucatinib | The Cmaxss of tucatinib will be determined at steady state. | Cycle 2, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose |
| Tmax at steady state (Tmaxss) of tucatinib | The Tmaxss of tucatinib will be determined at steady state. | Cycle 2, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose |
| AUC0-12 at steady state (AUC0-12ss) of tucatinib | The AUC0-12ss of tucatinib will be determined at steady state. | Cycle 2, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose |
| t½ of tucatinib at steady state | The t½ of tucatinib will be determined at steady state. | Cycle 2, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose |
| CL/F at steady state (CL/Fss) of tucatinib | The CL/Fss of tucatinib will be determined at steady state. | Cycle 2, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose |
| Vz/F at steady state (Vz/Fss) of tucatinib | The Vz/Fss of tucatinib will be determined at steady state. | Cycle 2, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose |
| Objective Response Rate (ORR) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) | ORR is defined as the percentage of participants who have a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience a CR or PR based on RECIST 1.1 will be presented. | Up to approximately 19 months |
| Duration of Response (DOR) Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) | For participants who demonstrate a confirmed complete response (CR: Disappearance of all target lesions) or confirmed Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until disease progression or death. | Up to approximately 19 months |
| Changsha |
| Hunan |
| 421000 |
| China |
| Jilin Cancer Hospital | Changchun | Jilin | 130012 | China |
| Fudan University Shanghai Cancer Center | Shanghai | 201321 | China |
| Tianjin Medical University Cancer Institute and Hospital | Tianjin | 300060 | China |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| C000705452 | tucatinib |
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