Continuation Clinical Trial of Oral L-0010790038 in Advanced Cancer
It is standard practice in the development of drugs treating advanced cancer where standard
alternative therapy does not exist to continue to offer drug beyond the confines of the
parent protocol to patients who are plausibly receiving benefit from it (e.g., those
patients who are tolerant of and not progressing on the therapy of the base protocol). Such
practice avoids the situation of a responding or potentially responding patient being denied
drug after a study of limited duration.
Therefore, this protocol is designed to provide a mechanism for non-progressing patients on
L-001079038 protocols to receive drug until disease progression or unacceptable toxicity
occurs. There is no significant data capture with regard to safety or efficacy of
L-001079038 over the longer treatment period; only SAEs will be captured and reported.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the long-term safety and tolerability of L-001079038 administered orally in patients with advanced cancers.
Lee Krug, MD
Memorial Sloan-Kettering Cancer Center
United States: Food and Drug Administration
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|