Study of an Investigational Drug, ASP3026, in Patients With Advanced Malignancies (Solid Tumors and B-Cell Lymphoma)
This study has been completed.
Sponsor:
Astellas Pharma Inc
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01284192
First received: January 25, 2011
Last updated: June 27, 2016
Last verified: June 2016
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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 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 |
| 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 |
| Study Completion Date: | March 2016 |
| Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: ASP3026
Subjects will receive escalated doses of ASP3026 to determine the maximum tolerated dose (MTD)
|
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 (Adult, Senior) |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
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 |
| Study First Received: | January 25, 2011 |
| Last Updated: | June 27, 2016 |
| Health Authority: | United States: Food and Drug Administration |
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 |
ClinicalTrials.gov processed this record on September 30, 2016