NCT01284192

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2010

Longer than P75 for phase_1

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 26, 2011

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

June 28, 2016

Status Verified

June 1, 2016

Enrollment Period

3.2 years

First QC Date

January 25, 2011

Last Update Submit

June 27, 2016

Conditions

Advanced MalignanciesPositive for Anaplastic Lymphoma KinasePositive for Proto-Oncogene Tyrosine-Protein Kinase ROSSolid TumorB-Cell Lymphoma

Keywords

B-cell LymphomaAdvanced MalignanciesAnaplastic Lymphoma Kinase (ALK)ASP3026Solid Tumor

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability of ASP3026 assessed by recording of adverse events, laboratory assessments, vital signs, electrocardiograms (ECGs) and clinical observations

    Up to 30 days after last subject discontinues treatment

Secondary Outcomes (2)

  • Pharmacokinetic assessment through analysis of blood and urine samples

    Up to Day 29

  • Objective response rate (ORR)

    30 Days after the last subject discontinues treatment

Study Arms (1)

ASP3026

EXPERIMENTAL

Subjects will receive escalated doses of ASP3026 to determine the maximum tolerated dose (MTD)

Drug: ASP3026

Interventions

ASP3026DRUG

Tablet

ASP3026

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Site US160

Orange, California, 92868, United States

Location

Site US184

Sacramento, California, 95817, United States

Location

Site US11

Chicago, Illinois, 60637, United States

Location

Site US2688

Detroit, Michigan, 48201, United States

Location

Site US2492

Houston, Texas, 77030, United States

Location

Site US1905

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

  • Li T, LoRusso P, Maitland ML, Ou SH, Bahceci E, Ball HA, Park JW, Yuen G, Tolcher A. First-in-human, open-label dose-escalation and dose-expansion study of the safety, pharmacokinetics, and antitumor effects of an oral ALK inhibitor ASP3026 in patients with advanced solid tumors. J Hematol Oncol. 2016 Mar 10;9:23. doi: 10.1186/s13045-016-0254-5.

    PMID: 26966027DERIVED

MeSH Terms

Conditions

Lymphoma, B-Cell

Interventions

ASP3026

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Senior Medical Director

    Astellas Pharma Global Development

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2011

First Posted

January 26, 2011

Study Start

December 1, 2010

Primary Completion

February 1, 2014

Study Completion

March 1, 2016

Last Updated

June 28, 2016

Record last verified: 2016-06

Locations

US(6)