Researchers are looking for new ways to treat certain advanced or metastatic solid tumors. The goal of this study is to learn about the safety of MK-4716 and if people tolerate it when taken alone or with other treatments.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
250
Oral administration
Intravenous administration
Intravenous administration
Rutgers Cancer Institute of New Jersey ( Site 0052)
New Brunswick, New Jersey, United States
Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLT)
A DLT is defined as the occurrence of protocol-specified toxicities, unless clearly related to disease progression or intercurrent illness.
Time frame: Up to approximately 28 days
Number of Participants Who Experience an 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Time frame: Up to approximately 4 years
Number of Participants Who Discontinue Study Intervention Due to an 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Time frame: Up to approximately 4 years
Area Under the Concentration-Time Curve (AUC) of MK-4716
Blood samples will be collected to determine the AUC of MK-4716.
Time frame: At designated timepoints (up to approximately 58 days)
Maximum Plasma Concentration (Cmax) of MK-4716
Blood samples will be collected to estimate Cmax of MK-4716.
Time frame: At designated timepoints (up to approximately 58 days)
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NEXT Oncology ( Site 0051)
Irving, Texas, United States
RECRUITINGNEXT Virginia ( Site 0054)
Fairfax, Virginia, United States
RECRUITINGBlacktown Hospital ( Site 0455)
Sydney, New South Wales, Australia
RECRUITINGMonash Health ( Site 0452)
Clayton, Victoria, Australia
RECRUITINGThe Alfred Hospital ( Site 0453)
Melbourne, Victoria, Australia
RECRUITINGOne Clinical Research ( Site 0454)
Nedlands, Western Australia, Australia
RECRUITINGPrincess Margaret Cancer Centre ( Site 0001)
Toronto, Ontario, Canada
RECRUITINGCentre Hospitalier de l'Université de Montréal ( Site 0003)
Montreal, Quebec, Canada
RECRUITINGCentre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0002)
Québec, Quebec, Canada
RECRUITING...and 11 more locations
Trough Plasma Concentration (Ctrough) of MK-4716
Blood samples will be collected to determine the Ctrough of MK-4716.
Time frame: At designated timepoints (up to approximately 19 months)
Half-Life (t1/2) of MK-4716
Blood samples will be collected to determine the t1/2 of MK-4716.
Time frame: At designated timepoints (up to approximately 58 days)