Clinical trial design
ICH
This study was conducted according to the current International Conference on Harmonization (ICH) Guidelines for Good Clinical Practice and all applicable local and national regulations and ethical principles in accordance with the Declaration of Helsinki. All patients provided written informed consent. No central institutional review board (IRB) or ethics committee was used. The protocol and the informed consent document were reviewed and approved by the IRB or independent ethics committee of each participating center before study initiation. The study was conducted according to the Protection of Human Patients (21 Code of Federal Regulations (CFR) 50), IRBs (21 CFR 56), Obligations of Clinical Investigators (21 CFR 312.60–312.69) and/or the current ICH Technical Requirements for Pharmaceuticals for Human Use Guidelines for Good Clinical Practice (ICH E6) and all other applicable regulations. Participants were not compensated for study participation, although certain trial-related expenses (for example, hotel rooms and transportation) were reimbursed for some patients. This was an open-label, dose-escalation/cohort-expansion phase 1 study (