A Dose-Escalation Study to Evaluate the Safety and Tolerability of SCH 717454 in Combination With Different Treatment Regimens in Subjects With Advanced Solid Tumors (Phase 1B/2; Protocol No. P04722)
Inclusion Criteria:
- Each subject must be willing and able to provide written informed consent for the
trial.
- Each subject must be ±18 years of age. A subject may be of either sex and of any
race/ethnicity;
- Part 1: Each subject must have a histologically or cytologically confirmed advanced
malignant solid tumor;
- Part 2: Each subject must have a histologically or cytologically confirmed, with
measurable disease (as defined by RECIST), advanced, malignant solid tumor.
- Each subject must have an Eastern Cooperative Oncology Group (ECOG) performance
status (PS) of <=2.
- Each subject must have adequate organ function within 3 weeks prior to first study
drug administration.
Exclusion Criteria:
- A subject must not have known treated or untreated leptomeningeal metastasis or a
metastatic central nervous system lesion.
- A subject must not have a history of another malignancy
- A subject must not have received prior therapy with any anti-IGF-1R monoclonal
antibody.
- A subject must not have received radiation therapy within 2 weeks prior to first
study drug administration.
- A subject must not have received radiation therapy to >25% of his/her total bone
marrow during his/her lifetime.
- A subject must not have undergone major surgery within 3 weeks prior to first study
drug administration.
- A subject must not have known human immunodeficiency virus (HIV) infection or a known
HIV-related malignancy.
- A subject must not have known active hepatitis B or C.
- A subject must not have any serious or uncontrolled infection.
- A subject must not have uncontrolled diabetes mellitus.
- A subject must not have had any of the following within 6 months prior to first study
drug administration: myocardial infarction, severe/unstable angina pectoris,
coronary/peripheral artery bypass graft, symptomatic congestive heart failure,
clinically significant cardiac dysrhythmia or clinically significant
electrocardiogram (ECG) abnormality, cerebrovascular accident or transient ischemic
attack, or seizure disorder.