The purpose of this study is to characterize the safety and tolerability of JNJ-63709178
and identify the recommended Phase 2 dose(s) (RP2D) and schedule for JNJ-63709178 in Part
1 and to characterize the safety and tolerability of JNJ-63709178 at the RP2D(s) in Part
2.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02715011.
Locations matching your search criteria
United States
Pennsylvania
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)Status: Active
Name Not Available
This is first-in-human (FIH) Phase 1, open-label (identity of assigned study drug will be
known), multicenter, dose escalation study with dose expansion to identify the RP2D and
to evaluate the safety, tolerability, and preliminary antitumor activity of JNJ-63709178
in adult participants with relapsed or refractory acute myeloid leukemia (AML) who are
ineligible for or have exhausted standard therapeutic options. The study will be
conducted in 2 parts: dose escalation and dose expansion. The study is divided into 3
periods: a Screening Phase (within 28 days before the first dose of study drug), a
Treatment Phase (first dose of study drug until the last dose of study drug) and a
Post-treatment Follow-up Phase (up to the end of study participation or end of study).
Participants' safety will be monitored throughout the study.
Lead OrganizationJanssen Pharmaceuticals
