Clinical Study of MK-4884 in Participants With Advanced or Metastatic Solid Tumors (MK-4884-001)
ConditionMalignant Neoplasm
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMerck Sharp & Dohme LLC
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Sequential
Treatments tested in this trial
MK-4884
DrugOral Administration
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: MK-4884 Dose Escalation Schedule AExperimental treatment 1 intervention
Group B: MK-4884 Dose Escalation Schedule BExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to approximately 21 days2
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.
Time frame
Up to approximately 39 months3
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.
Time frame
Up to approximately 39 monthsSecondary outcomes
1
Area Under the Concentration-Time Curve (AUC) of MK-4884
Blood samples will be collected to determine the AUC of MK-4884 in plasma.
Time frame
At designated timepoints (up to approximately 15 days)2
Maximum Plasma Concentration (Cmax) of MK-4884
Blood samples will be collected to determine the Cmax of MK-4884 in plasma.
Time frame
At designated timepoints (up to approximately 15 days)3
Trough Plasma Concentration (Ctrough) of MK-4884
Blood samples will be collected to determine the Ctrough of MK-4884 in plasma.
Time frame
At designated timepoints (up to approximately 39 months)4
Time to Maximum Plasma Concentration (Tmax) of MK-4884
Blood samples will be collected to determine the Tmax of MK-4884 in plasma.
Time frame
At designated timepoints (up to approximately 15 days)Sponsors and contacts
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Source ClinicalTrials.gov