A Phase I, Open-label, Dose-escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Intravenously Administered ATI-1123, a Liposomal Docetaxel Formulation, on an Every 3 Week Schedule, in Patients With Advanced Solid Tumors
The majority of advanced stage human cancers are fatal if not treated promptly and
aggressively. Standard treatments include chemotherapy, radiation therapy and surgery.
Docetaxel, the active ingredient in ATI-1123 and the FDA approved drug Taxotere, is a
chemotherapy given by IV to patients to treat various types of cancers.
Docetaxel is a poorly water soluble semi-synthetic taxane analog commonly used in the
treatment of a variety of solid tumors including non-small cell lung, prostate, breast,
gastric and head and neck cancer. Because of its poor water solubility it is formulated with
co-solvents that can potentially contribute to treatment related adverse events such as
hypersensitivity. Current taxane formulations often complicate drug delivery and can alter
both pharmacokinetic and toxicity profiles.
Results from nonclinical evaluations show that ATI-1123 retains the antineoplastic activity
of docetaxel while removing the need for unwanted solvents like Tween 80. The
administration of ATI-1123 versus other docetaxel chemotherapy formulations is expected to
reduce hypersensitivity reactions (redness, swelling, itching at the infusion site),
eliminate the requirement for premedications, have a broader therapeutic index, and enhance
systemic docetaxel exposure.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the (MTD) and (DLTs) of ATI-1123 administered every 3 weeks, over a range of doses in patients with advanced solid tumors.
Duration of study
Anthony W Tolcher, MD
South Texas Accelerated Research Therapeutics (START)
United States: Food and Drug Administration
|Cancer Therapy and Research Center (CTRC)||San Antonio, Texas 78229|
|Mary Crowley Cancer Research Centers (MCCRC)||Dallas, Texas 75230|