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

Primary Purpose

Advanced Malignancies, Positive for Anaplastic Lymphoma Kinase, Positive for Proto-Oncogene Tyrosine-Protein Kinase ROS

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

ASP3026

About this trial

This is an interventional treatment trial for Advanced Malignancies focused on measuring B-cell Lymphoma, Advanced Malignancies, Anaplastic Lymphoma Kinase (ALK), ASP3026, Solid Tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Site US160
Site US184
Site US11
Site US2688
Site US2492
Site US1905

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ASP3026

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pharmacokinetic assessment through analysis of blood and urine samples

Objective response rate (ORR)

Objective response rate is the proportion of subjects who experience complete response/remission (CR) or partial response/remission (PR)

Full Information

NCT ID

NCT01284192

First Posted

January 25, 2011

Last Updated

June 27, 2016

Sponsor

Astellas Pharma Inc

1. Study Identification

Unique Protocol Identification Number

NCT01284192

Brief Title

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

Official Title

A Phase 1, Multicenter, Open-Label, Dose Escalation Study of ASP3026 in Subjects With Advanced Malignancies

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Completed

Study Start Date

December 2010 (undefined)

Primary Completion Date

February 2014 (Actual)

Study Completion Date

March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Astellas Pharma Inc

4. Oversight

Data Monitoring Committee

5. Study Description

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Advanced Malignancies, Positive for Anaplastic Lymphoma Kinase, Positive for Proto-Oncogene Tyrosine-Protein Kinase ROS, Solid Tumor, B-Cell Lymphoma

Keywords

B-cell Lymphoma, Advanced Malignancies, Anaplastic Lymphoma Kinase (ALK), ASP3026, Solid Tumor

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

46 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ASP3026

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

ASP3026

Intervention Description

Tablet

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Pharmacokinetic assessment through analysis of blood and urine samples

Time Frame

Up to Day 29

Title

Objective response rate (ORR)

Description

Objective response rate is the proportion of subjects who experience complete response/remission (CR) or partial response/remission (PR)

Time Frame

30 Days after the last subject discontinues treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Senior Medical Director

Organizational Affiliation

Astellas Pharma Global Development

Official's Role

Study Director

Facility Information:

Facility Name

Site US160

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

Facility Name

Site US184

City

Sacramento

State/Province

California

ZIP/Postal Code

95817

Country

United States

Facility Name

Site US11

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

Facility Name

Site US2688

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

Facility Name

Site US2492

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Site US1905

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

26966027

Citation

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.

Results Reference

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

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