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Study of an Investigational Drug, ASP3026, in Patients With Advanced Malignancies (Solid Tumors and B-Cell Lymphoma)

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ClinicalTrials.gov Identifier: NCT01284192
Recruitment Status : Completed
First Posted : January 26, 2011
Last Update Posted : June 28, 2016
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Study Description
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Brief Summary:
This study is to evaluate the safety and anti-tumor activity of ASP3026 in patients with advanced malignancies (solid tumors and B-cell lymphoma).

Condition or disease Intervention/treatment Phase
Advanced Malignancies Positive for Anaplastic Lymphoma Kinase Positive for Proto-Oncogene Tyrosine-Protein Kinase ROS Solid Tumor B-Cell Lymphoma Drug: ASP3026 Phase 1

Detailed Description:
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, approximately 20 additional subjects with Anaplastic Lymphoma Kinase (ALK) abnormalities 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Multicenter, Open-Label, Dose Escalation Study of ASP3026 in Subjects With Advanced Malignancies
Study Start Date : December 2010
Actual Primary Completion Date : February 2014
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: ASP3026
Subjects will receive escalated doses of ASP3026 to determine the maximum tolerated dose (MTD)
 Drug: ASP3026
Tablet


Outcome Measures
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Primary Outcome Measures :
  1. Safety and tolerability of ASP3026 assessed by recording of adverse events, laboratory assessments, vital signs, electrocardiograms (ECGs) and clinical observations [ Time Frame: Up to 30 days after last subject discontinues treatment ]

Secondary Outcome Measures :
  1. Pharmacokinetic assessment through analysis of blood and urine samples [ Time Frame: Up to Day 29 ]
  2. Objective response rate (ORR) [ Time Frame: 30 Days after the last subject discontinues treatment ]
    Objective response rate is the proportion of subjects who experience complete response/remission (CR) or partial response/remission (PR)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 (dose escalation subjects only)
  • 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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01284192


Locations
United States, California
Site US160
Orange, California, United States, 92868
Site US184
Sacramento, California, United States, 95817
United States, Illinois
Site US11
Chicago, Illinois, United States, 60637
United States, Michigan
Site US2688
Detroit, Michigan, United States, 48201
United States, Texas
Site US2492
Houston, Texas, United States, 77030
Site US1905
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Senior Medical Director Astellas Pharma Global Development
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01284192     History of Changes
Other Study ID Numbers: A3026-CL-0101
First Posted: January 26, 2011    Key Record Dates
Last Update Posted: June 28, 2016
Last Verified: June 2016

Keywords provided by Astellas Pharma Inc:
B-cell Lymphoma
Advanced Malignancies
Anaplastic Lymphoma Kinase (ALK)
ASP3026
Solid Tumor

Additional relevant MeSH terms:
Lymphoma
Neoplasms
Lymphoma, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
 Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin