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

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

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.

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

Conditions
-----------------
Solid Tumor

Intervention / Treatment
-----------------
* Drug: ASP3026


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ASP3026<br> | Drug: ASP3026<br>* oral<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anti-cancer, ASP3026, Anaplastic Lymphoma Kinase (ALK)