Study of an Investigational Drug, ASP3026, in Patients With Solid Tumors

A Phase I, Non-randomized, Open-label, Repeat Oral Administration Study of ASP3026 in Patients With Solid Tumors

A study to evaluate the safety and anti-tumor activity of ASP3026 in patients with advanced malignancies (solid tumors).

Study Overview

• Status: Completed
• Conditions: Solid Tumor
• Intervention / Treatment: Drug: ASP3026

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. 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. The Safety Data Review Committee may elect to enroll additional subjects in a cohort to further evaluate the dose level. Each cycle will include 28 days of continuous dosing with ASP3026. Treatment with ASP3026 may continue until one of the discontinuation criteria is met.

The maximum tolerated dose (MTD) is defined as the highest dose of ASP3026 on a dosing schedule at which < 33% of subjects experience a DLT during Cycle 1. The MTD or lower dose, as determined by the Safety Data Review Committee, will be the recommended Phase 2 dose (RP2D). Twelve additional patients will be treated at the RP2D to further evaluate safety and tolerability.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Kansai, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) performance status < 2.
• Histologically or cytologically confirmed diagnosis of a relapsed/refractory solid tumor

• Patient 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
• Life expectancy > 12 weeks
• Able to be hospitalized from 1 day prior to the initial dosing until day 15 of the dosing, and from day 27 until day 29 of the dosing

Exclusion Criteria:

• Patient exhibits persistent subjective and objective findings of toxicity ≥ Grade 2 (CTCAE v4.0-JCOG) from the previous cancer treatment with antitumor effect (except of alopecias)
• Received previous treatment with antitumor effect within 21 days prior to the scheduled initial dosing
• Patient had a major surgical procedure within 21 days prior to the scheduled initial dosing or a major surgical procedure scheduled during the course of the study
• Use of an investigational drug or device within 21 days prior to the scheduled initial dosing
• Use of blood transfusion or hematopoietic growth factors within 14 days prior to the scheduled initial dosing
• A positive test for hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV)
• Known history of a positive test for human immunodeficiency virus (HIV) infection
• Patient has central nervous system (CNS) or leptomeningeal involvement with clinical symptoms

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ASP3026	Drug: ASP3026; oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics of ASP3026 by assessment of area under the curve over the time (AUC) and maximum concentration (Cmax) in plasma and urine		Up to Day 29
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

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc

Publications and helpful links

General Publications

• Ono A, Murakami H, Seto T, Shimizu T, Watanabe S, Takeshita S, Takeda K, Toyoshima J, Nagase I, Bahceci E, Morishita M, Morita S, Fukuoka M, Nakagawa K. Safety and Antitumor Activity of Repeated ASP3026 Administration in Japanese Patients with Solid Tumors: A Phase I Study. Drugs R D. 2021 Mar;21(1):65-78. doi: 10.1007/s40268-020-00331-2. Epub 2020 Dec 17.
• Ono A, Murakami H, Serizawa M, Wakuda K, Kenmotsu H, Naito T, Taira T, Koh Y, Ohde Y, Nakajima T, Endo M, Takahashi T. Drastic initial response and subsequent response to two ALK inhibitors in a patient with a highly aggressive ALK-rearranged inflammatory myofibroblastic tumor arising in the pleural cavity. Lung Cancer. 2016 Sep;99:151-4. doi: 10.1016/j.lungcan.2016.07.002. Epub 2016 Jul 5.

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: June 30, 2011
• First Submitted That Met QC Criteria: July 22, 2011
• First Posted (Estimate): July 25, 2011

Study Record Updates

• Last Update Posted (Estimate): June 11, 2014
• Last Update Submitted That Met QC Criteria: June 10, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: Anti-cancer; ASP3026; Anaplastic Lymphoma Kinase (ALK)
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 3026-CL-0102