Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Amgen
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Men or women ≥ 18 years old
Subjects must have a pathologically documented, definitively diagnosed, advanced solid tumor
Subjects with primary central nervous system (CNS) tumors or metastases resected or have received radiation therapy ending at least 4 weeks prior to study day 1 are eligible providing they meet all of the following criteria: a) residual neurological symptoms grade ≤ 1; 2) no dexamethasone treatment; and c) follow-up MRI shows no new lesions appearing
Measurable disease per RECIST guidelines (subjects with non-measurable, but evaluable disease are also eligible for the dose escalation portion of the study)
Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2
Competent to sign and date an Institutional Review Board approved informed consent form
Adequate hematologic and renal function as determined by laboratory blood and urine tests
You may not be if
Men and woman of reproductive potential, unwilling to practice a highly effective method of birth control for the duration of the study and continuing for 2 weeks (for women) and 12 weeks (for men) after receiving the last dose of study drug.
Women who are lactating/breastfeeding or planning to become pregnant during the duration of the study
History of bleeding diathesis
Myocardial infarction within 6 months of study day 1, symptomatic congestive heart failure (New York Heart Association \> class II), unstable angina, or unstable cardiac arrhythmia requiring medication, or uncontrolled hypertension
A baseline ECG QTc \> 470 ms
Active infection requiring (IV) antibiotics within 2 weeks of study enrollment
Significant gastrointestinal disorder(s), in the opinion of the investigator, that may influence drug absorption
Known positive test for HIV
Known acute or chronic hepatitis B or hepatitis C infection as determined by serologic tests
Anti-tumor therapy within 28 days of study day 1 including chemotherapy, antibody therapy, retinoid therapy, or other investigational agent
Major surgery within 30 days of study day 1
Any co-morbid medical disorder that may increase the risk of toxicity, in the opinion of the investigator or sponsor
Clareo Health | A Study of AMG 337 in Subjects With Advanced Solid Tumors
