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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01284192
First received: January 25, 2011
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

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

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1, Multicenter, Open-Label, Dose Escalation Study of ASP3026 in Subjects With Advanced Malignancies

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetic assessment through analysis of blood and urine samples [ Time Frame: Up to Day 29 ] [ Designated as safety issue: No ]
  • Objective response rate (ORR) [ Time Frame: 30 Days after the last subject discontinues treatment ] [ Designated as safety issue: No ]
    Objective response rate is the proportion of subjects who experience complete response/remission (CR) or partial response/remission (PR)


Enrollment: 46
Study Start Date: December 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ASP3026 Drug: ASP3026
Tablet

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01284192

Locations
United States, California
University of California - Irvine
Orange, California, United States, 92868
University of California - Davis
Sacramento, California, United States, 95817
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Michigan
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, Texas
MD Anderson Cancer Insititute
Houston, Texas, United States, 77030
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Senior Medical Director Astellas Pharma Global Development
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01284192     History of Changes
Other Study ID Numbers: A3026-CL-0101
Study First Received: January 25, 2011
Last Updated: July 15, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on July 24, 2014