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
NEXT Oncology ( Site 0051)
Irving, Texas, United States
RECRUITINGNEXT Virginia ( Site 0054)
Fairfax, Virginia, United States
RECRUITINGRambam Health Care Campus ( Site 0252)
Haifa, Israel
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 5 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 5 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)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Rabin Medical Center ( Site 0253)
Petah Tikva, Israel
RECRUITINGSheba Medical Center ( Site 0251)
Ramat Gan, Israel
RECRUITINGHospital General Universitari Vall d Hebron ( Site 0360)
Barcelona, Spain
RECRUITINGHospital Clinic de Barcelona ( Site 0362)
Barcelona, Spain
RECRUITINGHospital Universitario Fundacion Jimenez Diaz ( Site 0361)
Madrid, Spain
RECRUITINGTrough 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)