A Phase 1, Multicenter, Open-Label, Dose Escalation Study of ASP3026 in Subjects With Advanced Malignancies
This study will be conducted using a traditional 3 + 3 dose escalation study design.
Enrollment of at least 3 subjects is planned for each dosing cohort until the Maximum
Tolerated Dose (MTD) is determined. Up to three additional subjects per cohort may be
enrolled if each additional subject is known to be positive for Anaplastic Lymphoma Kinase
(ALK) or Proto-Oncogene Tyrosine-Protein Kinase ROS (ROS) abnormalities. The decision to
expand a cohort or dose escalate will be based on the occurrence of dose limiting toxicities
(DLTs) in Cycle 1 that are considered by the Investigator to be related (possibly or
probably) to ASP3026. Intra-subject dose escalation will be allowed at the discretion of the
investigators. The Safety Data Review Committee may elect to enroll additional subjects in a
cohort to further evaluate the dose level. Once the MTD is determined, up to 20 additional
subjects will be enrolled at the Recommended Phase 2 Dose. Each cycle will include 28 days
of continuous dosing with ASP3026. Treatment with ASP3026 may continue until one of the
discontinuation criteria is met.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety and tolerability of ASP3026 assessed by recording of adverse events, laboratory assessments, vital signs, electrocardiograms (ECGs) and clinical observations
Up to 30 days after last subject discontinues treatment
No
Senior Medical Director
Study Director
Astellas Pharma Global Development
United States: Food and Drug Administration
A3026-CL-0101
NCT01284192
December 2010
April 2013
Name | Location |
---|---|
Karmanos Cancer Institute | Detroit, Michigan 48201 |
University of California - Irvine | Orange, California 92868 |
University of California - Davis | Davis, California 95616 |
South Texas Accelerated Research Therapeutics, Llc | San Antonio, Texas 78229 |
Univeristy of Chicago | Chicago, Illinois 60637 |
MD Anderson Cancer Insititute | Houston, Texas 77030 |