Study of an Investigational Drug, ASP3026, in Patients With Advanced Malignancies (Solid Tumors and B-Cell Lymphoma)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01284192 |
Recruitment Status :
Completed
First Posted : January 26, 2011
Last Update Posted : June 28, 2016
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Condition or disease | Intervention/treatment | Phase |
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Advanced Malignancies Positive for Anaplastic Lymphoma Kinase Positive for Proto-Oncogene Tyrosine-Protein Kinase ROS Solid Tumor B-Cell Lymphoma | Drug: ASP3026 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 46 participants |
Allocation: | N/A |
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 |
Arm | Intervention/treatment |
---|---|
Experimental: ASP3026
Subjects will receive escalated doses of ASP3026 to determine the maximum tolerated dose (MTD)
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Drug: ASP3026
Tablet |
- 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 ]
- Pharmacokinetic assessment through analysis of blood and urine samples [ Time Frame: Up to Day 29 ]
- 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)

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
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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

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
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 |
Study Director: | Senior Medical Director | Astellas Pharma Global Development |
Responsible Party: | Astellas Pharma Inc |
ClinicalTrials.gov Identifier: | NCT01284192 |
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 |
B-cell Lymphoma Advanced Malignancies Anaplastic Lymphoma Kinase (ALK) ASP3026 Solid Tumor |
Lymphoma Neoplasms Lymphoma, B-Cell Neoplasms by Histologic Type Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin |