Malignant Neoplasm
Conditions
Brief summary
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.
Interventions
DRUGMK-4884
Oral Administration
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Has a histologically or cytologically confirmed diagnosis of 1 of the following unresectable (locally advanced) and/or advanced (metastatic) solid tumors: * Colorectal carcinoma (CRC) * Renal cell carcinoma (RCC) that contains a clear cell component (with or without sarcomatoid and/or rhabdoid features) * Nonsquamous non-small cell lung cancer (NSCLC) * Biliary tract cancer (BTC) (intra-or extrahepatic cholangiocarcinoma (CCA)) or gallbladder cancer (GBC) * Has measurable disease by Response Evaluation Criteria In Solid Tumors 1.1 (RECIST 1.1) * Has adequate organ function * Participants with human immunodeficiency virus (HIV) infection must have well controlled HIV on stable antiretroviral therapy (ART) for at least 4 weeks * Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load * Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
Exclusion criteria
* Has gastrointestinal malabsorption, a surgical procedure or a condition that could affect the absorption of the study drug * Has a history of clinically significant cardiac, cardiovascular and/or cerebrovascular disease * Has a serious nonhealing wound, ulcer, or bone fracture * Has an active infection(s) requiring systemic therapy * HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease * Known additional malignancy that is progressing or has required active treatment within the past 2 years * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis * Has a history of stem cell/solid organ transplant * Has not adequately recovered from major surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs) | Up to approximately 21 days | DLT is defined as the occurrence of protocol-specified toxicities, unless clearly related to disease progression or intercurrent illness. |
| Number of Participants Who Experience an Adverse Event (AE) | Up to approximately 39 months | 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. |
| Number of Participants Who Discontinue Study Treatment Due to an AE | Up to approximately 39 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Concentration-Time Curve (AUC) of MK-4884 | At designated timepoints (up to approximately 15 days) | Blood samples will be collected to determine the AUC of MK-4884 in plasma. |
| Maximum Plasma Concentration (Cmax) of MK-4884 | At designated timepoints (up to approximately 15 days) | Blood samples will be collected to determine the Cmax of MK-4884 in plasma. |
| Trough Plasma Concentration (Ctrough) of MK-4884 | At designated timepoints (up to approximately 39 months) | Blood samples will be collected to determine the Ctrough of MK-4884 in plasma. |
| Time to Maximum Plasma Concentration (Tmax) of MK-4884 | At designated timepoints (up to approximately 15 days) | Blood samples will be collected to determine the Tmax of MK-4884 in plasma. |
| Apparent Terminal Half-life (t½) of MK-4884 | At designated timepoints (up to approximately 15 days) | Blood samples will be collected to determine the t1/2 of MK-4884 in plasma. |
Countries
Canada, Israel, Japan, Switzerland, United States
Contacts
CONTACTToll Free Number
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Outcome results
None listed