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

Sponsor

Astellas Pharma Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT01284192

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

7.7

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	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

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.

Study Design

Study Type:

Interventional

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 :

Dec 1, 2010

Actual Primary Completion Date :

Feb 1, 2014

Actual Study Completion Date :

Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ASP3026 Subjects will receive escalated doses of ASP3026 to determine the maximum tolerated dose (MTD)	Drug: ASP3026 Tablet

Arm

Intervention/Treatment

Experimental: ASP3026

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

Drug: ASP3026

Tablet

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Site US160	Orange	California	United States	92868
2	Site US184	Sacramento	California	United States	95817
3	Site US11	Chicago	Illinois	United States	60637
4	Site US2688	Detroit	Michigan	United States	48201
5	Site US2492	Houston	Texas	United States	77030
6	Site US1905	San Antonio	Texas	United States	78229