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Researchers are looking for new ways to treat certain types of advanced and/or metastatic solid tumors.
The main goal of this study is to learn about the safety of different doses of MK-4884 and if participants tolerate them.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MK-4884 Dose Escalation Schedule A | Experimental | Participants will receive MK-4884 at varying dose levels until any of the criteria for discontinuation of the study intervention are met. |
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| MK-4884 Dose Escalation Schedule B | Experimental | Participants will receive MK-4884 at varying dose levels until any of the criteria for discontinuation of the study intervention are met. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-4884 | Drug | Oral Administration |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs) | DLT is defined as the occurrence of protocol-specified toxicities, unless clearly related to disease progression or intercurrent illness. | Up to approximately 21 days |
| Number of Participants Who Experience an Adverse Event (AE) | An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants with experience an AE will be reported. | Up to approximately 39 months |
| Number of Participants Who Discontinue Study Treatment Due to an AE | An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinued study treatment due to an AE will be reported. | Up to approximately 39 months |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time Curve (AUC) of MK-4884 | Blood samples will be collected to determine the AUC of MK-4884 in plasma. | At designated timepoints (up to approximately 15 days) |
| Maximum Plasma Concentration (Cmax) of MK-4884 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Toll Free Number | Contact | 1-888-577-8839 | Trialsites@msd.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NEXT Oncology ( Site 0151) | Recruiting | San Antonio | Texas | 78229 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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Blood samples will be collected to determine the Cmax of MK-4884 in plasma.
| At designated timepoints (up to approximately 15 days) |
| Trough Plasma Concentration (Ctrough) of MK-4884 | Blood samples will be collected to determine the Ctrough of MK-4884 in plasma. | At designated timepoints (up to approximately 39 months) |
| Time to Maximum Plasma Concentration (Tmax) of MK-4884 | Blood samples will be collected to determine the Tmax of MK-4884 in plasma. | At designated timepoints (up to approximately 15 days) |
| Apparent Terminal Half-life (t½) of MK-4884 | Blood samples will be collected to determine the t1/2 of MK-4884 in plasma. | At designated timepoints (up to approximately 15 days) |
| Rambam Health Care Campus ( Site 0051) | Recruiting | Haifa | 3109601 | Israel |
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| Rabin Medical Center ( Site 0053) | Recruiting | Petah Tikva | 4941492 | Israel |
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| National Cancer Center Hospital ( Site 0201) | Recruiting | Chūō | Tokyo | 104-0045 | Japan |
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