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A Phase 1, Multicenter, Open-Label, Dose Escalation Study of ASP3026 in Subjects With Advanced Malignancies

Phase 1
18 Years
Open (Enrolling)
Advanced Malignancies, B-Cell Lymphoma, Solid Tumor, Positive for Anaplastic Lymphoma Kinase, Positive for Proto-Oncogene Tyrosine-Protein Kinase ROS

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Trial Information

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.

Inclusion Criteria:

- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

- Histologically or cytologically confirmed diagnosis of a relapsed/refractory solid
tumor or B-cell lymphoma and meets at least 1 of the following criteria:

- Disease progression despite standard therapies

- No standard therapies are available or such therapies are not anticipated to
result in a durable response

- Standard therapies are considered unsuitable or have been refused

- Able to take oral medications

- Life expectancy > 12 weeks

- For the expansion cohort of the study, all subjects must be confirmed to be positive
for ALK gene abnormalities

- Subjects with stable brain metastasis will be allowed

Exclusion Criteria:

- Active central nervous system (CNS) metastases or leptomeningeal involvement as
assessed through medical history review and physical examination

- Known history of a positive test for hepatitis B surface antigen (HBsAg) or hepatitis
C antibody (anti-HCV)

- Known hereditary or acquired immunodeficiency syndrome or human immunodeficiency
virus (HIV) infection

- Cardiac arrhythmias > Grade 1 using National Cancer Institute Common Terminology
Criteria for Adverse Events (NCI CTCAE) v. 4.03

- Class 3 or 4 New York Heart Association congestive heart failure, acute coronary
syndrome, myocardial infarction or cerebrovascular accident within 6 months prior to
Cycle 1, Day 1

- Inadequate bone marrow, renal, and/or hepatic function

- Confirmed active peptic ulcer disease or history of gastrointestinal bleeding within
the past 3 months

- Known history of long QT syndrome

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and tolerability of ASP3026 assessed by recording of adverse events, laboratory assessments, vital signs, electrocardiograms (ECGs) and clinical observations

Outcome Time Frame:

Up to 30 days after last subject discontinues treatment

Safety Issue:


Principal Investigator

Senior Medical Director

Investigator Role:

Study Director

Investigator Affiliation:

Astellas Pharma Global Development


United States: Food and Drug Administration

Study ID:




Start Date:

December 2010

Completion Date:

April 2013

Related Keywords:

  • Advanced Malignancies
  • B-Cell Lymphoma
  • Solid Tumor
  • Positive for Anaplastic Lymphoma Kinase
  • Positive for Proto-Oncogene Tyrosine-Protein Kinase ROS
  • Advanced Malignancies
  • B-cell Lymphoma
  • Solid Tumor
  • ASP3026
  • Anaplastic Lymphoma Kinase (ALK)
  • Neoplasms
  • Lymphoma
  • Lymphoma, B-Cell



Karmanos Cancer InstituteDetroit, Michigan  48201
University of California - IrvineOrange, California  92868
University of California - DavisDavis, California  95616
South Texas Accelerated Research Therapeutics, LlcSan Antonio, Texas  78229
Univeristy of ChicagoChicago, Illinois  60637
MD Anderson Cancer InsitituteHouston, Texas  77030