Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Pfizer
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Histologically or cytologically confirmed HER2+ advanced breast cancer, gastric or GEC, and colorectal cancer
Have progressed at least one previous therapeutic regimen and either no longer are candidates for standard therapy, have no standard therapy available, or choose not to pursue standard therapy
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance within 7 days prior to allocation
Has life expectancy \>6 months in the opinion of the investigator
Have measurable disease per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 as assessed by the local site investigator/radiologist
Must test negative for hepatitis B surface antigen (HBsAg)
If there is a history of hepatitis C virus (HCV) infection, has undetectable HCV viral load at screening
For males, agree to be abstinent from heterosexual intercourse, or agree to use acceptable contraception, for the duration of study and 1 week after
For females, is not pregnant or breastfeeding AND one of the following applies:
Is not a woman of childbearing potential (WOCBP)
Is a WOCBP and uses highly effective contraception and is not pregnant
You may not be if
History of prior cancer within \<3 year, except for adequately treated basal cell or squamous cell carcinoma of the skin, cervical cancer in situ, or other in situ carcinomas which needs discussion between the investigator and the Sponsor
Participants with leptomeningeal disease are excluded
Has symptomatic central nervous system (CNS) metastases
Has active human immunodeficiency virus (HIV), hepatitis B virus, or HCV infection
Has had chemotherapy, immunotherapy, radioimmunotherapy, definitive radiation, or biological cancer therapy or treatment with an investigational product within 4 weeks (2 weeks for palliative radiation) before the first dose of study intervention
Has an active infection requiring therapy
Has refractory nausea/vomiting, chronic gastrointestinal disease, or significant bowel resection
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study
Has a QTc prolongation
Has uncontrolled illness including but not limited to ongoing symptomatic congestive heart failure (New York Heart Association \[NYHA\] Class III or IV heart failure), unstable angina pectoris, cardiac arrhythmia, and psychiatric illness that would limit compliance with study requirements
Has had major surgery within 4 weeks prior to first dose of study intervention
Is currently participating in another clinical trial
Has psychiatric or substance abuse disorder
Clareo Health | Safety and Pharmacokinetics of Tucatinib (MK-7119) in Chinese Participants With Cancer (MK-7119-002)
