A Phase I, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of INNO-406 in Adult Patients With Imatinib-Resistant or Intolerant Philadelphia Chromosome-Positive (Ph+) Leukemias
The purpose of this study is to determine the safety, tolerability and pharmacokinetic
profile of INNO-406 when administered as a daily oral agent in adult patients with
imatinib-resistant or intolerant Philadelphia chromosome-positive (Ph+) leukemias.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of INNO-406 when administered as a single agent to adult patients with imatinib-resistant or intolerant Ph+ leukemias.
Hagop Kantarjian, M.D.
University of Texas, MD Anderson Cancer Center, Houston, TX 713-792-7026 email@example.com
United States: Food and Drug Administration
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|
|University of Texas MD Anderson Cancer Center||Houston, Texas 77030|