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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01401504
First received: June 30, 2011
Last updated: June 10, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention Phase
Solid Tumor
Drug: ASP3026
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Objective response rate (ORR) [ Time Frame: 30 Days after the last subject discontinues treatment ] [ Designated as safety issue: No ]
    Objective response rate is the proportion of subjects who experience complete response/remission (CR) or partial response/remission (PR)


Enrollment: 29
Study Start Date: May 2011
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ASP3026 Drug: ASP3026
oral

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01401504

Locations
Japan
Kansai, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Use Central Contact Astellas Pharma Inc
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01401504     History of Changes
Other Study ID Numbers: 3026-CL-0102
Study First Received: June 30, 2011
Last Updated: June 10, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Astellas Pharma Inc:
Anti-cancer
ASP3026
Anaplastic Lymphoma Kinase (ALK)

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on July 31, 2014