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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01401504
Recruitment Status : Completed
First Posted : July 25, 2011
Last Update Posted : June 11, 2014
Information provided by (Responsible Party):
Astellas Pharma Inc

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

Condition or disease Intervention/treatment Phase
Solid Tumor Drug: ASP3026 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Non-randomized, Open-label, Repeat Oral Administration Study of ASP3026 in Patients With Solid Tumors
Study Start Date : May 2011
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: ASP3026 Drug: ASP3026

Primary Outcome Measures :
  1. Safety and tolerability of ASP3026 assessed by recording of adverse events, laboratory assessments, vital signs, electrocardiograms (ECGs) and clinical observations [ Time Frame: Up to 30 days after last subject discontinues treatment ]

Secondary Outcome Measures :
  1. Pharmacokinetics of ASP3026 by assessment of area under the curve over the time (AUC) and maximum concentration (Cmax) in plasma and urine [ Time Frame: Up to Day 29 ]
  2. Objective response rate (ORR) [ Time Frame: 30 Days after the last subject discontinues treatment ]
    Objective response rate is the proportion of subjects who experience complete response/remission (CR) or partial response/remission (PR)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01401504

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Kansai, Japan
Sponsors and Collaborators
Astellas Pharma Inc
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Study Chair: Use Central Contact Astellas Pharma Inc
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Astellas Pharma Inc Identifier: NCT01401504    
Other Study ID Numbers: 3026-CL-0102
First Posted: July 25, 2011    Key Record Dates
Last Update Posted: June 11, 2014
Last Verified: June 2014
Keywords provided by Astellas Pharma Inc:
Anaplastic Lymphoma Kinase (ALK)
Additional relevant MeSH terms:
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