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

NCT01401504 | Completed Phase 1 DMC

• 1 other identifier: 3026-CL-0102
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Solid Tumor

Keywords

Anti-cancer; ASP3026; Anaplastic Lymphoma Kinase (ALK)

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)

• 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)

  30 Days after the last subject discontinues treatment

Study Arms (1)

ASP3026

EXPERIMENTAL

Drug: ASP3026

Interventions

ASP3026 DRUG

oral

ASP3026

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (1)

Unknown Facility

Kansai, Japan

Location

Related Publications (2)

• 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.

  PMID: 33331996 DERIVED

• 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.

  PMID: 27565932 DERIVED

MeSH Terms

Interventions

ASP3026

Study Officials

• Use Central Contact

  Astellas Pharma Inc

  STUDY CHAIR

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: June 30, 2011
• First Posted: July 25, 2011
• Study Start: May 1, 2011
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: June 11, 2014

Record last verified: 2014-06

Locations

JP (1)