Overview of Study Design: This is a phase 1, multicenter, open-label, multiple-dose, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of TAK-960 in patients with advanced nonhematologic malignancies. This study will be the first to administer TAK-960 to humans. The patient population will consist of adults with a nonhematologic malignancy for which standard treatment is no longer effective or does not offer curative or life-prolonging potential, or for which no standard treatment is available.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
TAK-960 administered orally once a day for 21-days of a 28-day treatment cycle. A 3 + 3 dose escalation scheme will be employed.
South Texas Accelerated Research Therapeutics (START)
San Antonio, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of TAK-960
Adverse events, serious adverse events, assessments of clinical laboratory values, vital sign measurements and electrocardiograms (ECGs)
Time frame: up to 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.