The purpose of this study is to determine the safety and effectiveness 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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Oral, twice daily self-administration of 10 mg and/or 50 mg tablets
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Charite University of Medicine
Berlin, Germany
Johann Wolfgang Goethe Universität
Frankfurt am Main, Germany
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.
Time frame: One year
To determine the safety profile (including acute and chronic toxicities) and tolerability of INNO-406 in this patient population.
Time frame: One year
To determine the pharmacokinetic (PK) profile of INNO-406.
Time frame: One year
To assess BCR-ABL transcript levels and to analyze BCR-ABL mutations.
Time frame: One year
To assess leukemia response rates in this patient population.
Time frame: One year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Heidelberg Medical Clinic
Mannheim, Germany
Chaim Sheba Medical Center
Tel Litwinsky, Israel