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

Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01284192
• Other study ID #: A3026-CL-0101
• Status: Completed
• Phase: Phase 1
• First received: January 25, 2011
• Last updated: June 27, 2016
• Start date: December 2010
• Est. completion date: March 2016

Study information

• Verified date: June 2016
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: March 2016
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• ASP3026
Tablet

Locations

Country	Name	City	State
United States	Site US11	Chicago	Illinois
United States	Site US2688	Detroit	Michigan
United States	Site US2492	Houston	Texas
United States	Site US160	Orange	California
United States	Site US184	Sacramento	California
United States	Site US1905	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Pharmacokinetic assessment through analysis of blood and urine samples		Up to Day 29	No
Secondary	Objective response rate (ORR)	Objective response rate is the proportion of subjects who experience complete response/remission (CR) or partial response/remission (PR)	30 Days after the last subject discontinues treatment	No