Phase 1 Study Evaluating the Tolerance and Biologic Activity of Intravenous Infusions of Tigecycline in Patients With Relapsed or Refractory AML
Relapsed and refractory hematologic malignancies have poor responses to standard therapy and
are associated with a poor prognosis. For example, relapsed acute myeloid leukemia (AML) is
a highly aggressive and resistant disease, particularly when associated with first complete
response (CR) duration of less than 12 months. Thus, there is an urgent need for new agents
in relapsed and refractory hematologic malignancies such as acute leukemia. In elderly
patients, where the tolerance of aggressive induction therapy is often poor and curative
options such as bone marrow transplantation HSCT are not available, the need for effective
non-aggressive drug regimens for AML is even greater.
Tigecycline is a glycylcycline derivative of tetracycline. Tigecycline is currently
indicated for the treatment of complicated skin and skin structure infections, and
complicated intra-abdominal infections. This clinical trial is a Phase I dose escalation
study of tigecycline in patients with relapsed or refractory AML or those with newly
diagnosed disease not eligible for induction chemotherapy.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Toxicity evaluated according to CTCAE version 4.03
Reviewed at each visit and assessed at the end of each 3-week cycle
Yes
Aaron Schimmer, MD
Study Director
University Health Network, Toronto
Canada: Ethics Review Committee
OZM-029
NCT01332786
March 2011
December 2013
Name | Location |
---|---|
University of California, Los Angeles | Los Angeles, California |
The University of Kansas Medical Center | Kansas City, Kansas 66160 |