The primary objective of this study is to determine the maximum tolerated dose (MTD) and to establish the recommended phase 2 dose of oral OSI-027 when administered via 3 schedules, namely, intermittent, weekly, and continuous in patients with advanced solid tumors or lymphoma, namely, intermittent, weekly, and continuous.
The study will open with Schedule 1 (S1, intermittent) with initiation of Schedule 2 (S2, weekly) and Schedule 3 (S3, continuous), which may occur in parallel after observation of clinically significant related dose limiting toxicity (DLT) in the S1 schedule. Dosing will be initiated on Day 1 with intermittent weekly dosing continuing for 21 days (1 Treatment Period). Expansion of Dose Escalation Cohorts may occur for S1 and S2 at the recommended phase 2 dose level(s) and a Biomarker Expansion Cohort may be opened in S1 and/or S2.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
128
Administered orally
Karmanos Cancer Institute
Detroit, Michigan, United States
University Hospitals Leuven
Leuven, Belgium
Royal Mardsen Hospital
Sutton, Surrey, United Kingdom
Maximum tolerated dose
Time frame: 21 days
Safety profile of OSI-027
Time frame: up to 5 years
Pharmacokinetic profile of OSI-027
Time frame: up to 23 days
Preliminary pharmacodynamic relationship with OSI-027 systemic exposure
Time frame: up to 23 days
Preliminary antitumor activity of OSI-027
Time frame: up to 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.