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

Phase 1
20 Years
Open (Enrolling)
Solid Tumor

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Trial Information

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

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.

Inclusion Criteria:

- Eastern Cooperative Oncology Group (ECOG) performance status < 2.

- Histologically or cytologically confirmed diagnosis of a relapsed/refractory solid

- 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

- 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

- Known history of a positive test for human immunodeficiency virus (HIV) infection

- Patient has central nervous system (CNS) or leptomeningeal involvement with clinical

Type of Study:


Study Design:

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

Outcome Measure:

Safety and tolerability of ASP3026 assessed by recording of adverse events, laboratory assessments, vital signs, electrocardiograms (ECGs) and clinical observations

Outcome Time Frame:

Up to 30 days after last subject discontinues treatment

Safety Issue:


Principal Investigator

Use Central Contact

Investigator Role:

Study Chair

Investigator Affiliation:

Astellas Pharma Inc


Japan: Pharmaceuticals and Medical Devices Agency

Study ID:




Start Date:

May 2011

Completion Date:

March 2014

Related Keywords:

  • Solid Tumor
  • Anti-cancer
  • ASP3026
  • Anaplastic Lymphoma Kinase (ALK)
  • Neoplasms