Novartis PhII Ceritinib (LDK378) in R/R ALK+ Hem Malignancies
Status:
Withdrawn
Trial end date:
2022-10-01
Target enrollment:
Participant gender:
Summary
This is a phase II, single arm, unblinded study of ceritinib in patients with rel/ref
hematologic malignancies. Up to 24 evaluable subjects will be enrolled with an interim
analysis for efficacy after the first 9 subjects are enrolled. Any subject who takes at least
one dose of study drug will be evaluable for safety. Only subjects who complete at least 1
cycle of study drug and have clear progression on physical exam or have had at least one
restaging study will be considered evaluable for response. Each subject will receive the same
dose of 750mg po daily at the study entry. Subjects with stable disease or better will be
allowed to continue study drug until disease progression or until intolerable adverse events
or patient or physician decision. Intrapatient dose reductions will be allowed for adverse
events. This is a multicenter study with Duke as the lead site. Blood and tissue samples,
will be collected and used for exploratory analysis.