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

This study is currently recruiting participants.
Verified July 2012 by Astellas Pharma Inc

First Received on January 25, 2011.  
Last Updated on July 17, 2012  
History of Changes
This Clinical Trial Sponsored By: Astellas Pharma Inc
Information provided by (Responsible Party): Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01284192
 

Purpose for Clinical Trial

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 Study Intervention Clinical Trial 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: Study Interventional
Study Design: Endpoint Classification: Safety Study
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:

MedlinePlus related topics:
Cancer
Lymphoma

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures For Clinical Trial:

  • 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 For Clinical Trial:

  • 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)

Estimated Enrollment: 73
Study Start Date: December 2010
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)

Arms

Assigned Study 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. 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. 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
  • 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

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

Contacts
Contact: Astellas Pharma Global Development 800-888-7704 ext 5473 clintrials.info@us.astellas.com

Locations
United States, California
University of California – Irvine Recruiting
Orange, California, United States, 92868
University of California – Davis Recruiting
Sacramento, California, United States, 95817
United States, Illinois
Univeristy of Chicago Recruiting
Chicago, Illinois, United States, 60637
United States, Michigan
Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
United States, Texas
MD Anderson Cancer Insititute Recruiting
Houston, Texas, United States, 77030

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