A Pilot Study of OSI-461 in Patients With Chronic Lymphocytic Leukemia (CLL)

Overview

The objectives of this study are to evaluate the safety and efficacy of OSI-461 in CLL patients.

Full Title of Study: “A Pilot Trial of OSI-461 in Patients With Chronic Lymphocytic Leukemia”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)

Detailed Description

The primary objective of this study is to determine the activity of OSI-461 given twice daily orally in previously untreated CLL patients. The secondary objective is to evaluate the safety profile of OSI-461 in this patient population.

Interventions

  • Drug: OSI-461

Participating in This Clinical Trial

Inclusion Criteria

  • Diagnosis of CLL established by bone marrow aspiration and biopsy or flow cytometry of peripheral blood. – No previous therapy for CLL. – Expected remaining life span greater than or equal to six months. – 18 years or older. – Willingness and ability to sign an informed consent. Exclusion Criteria:

  • Other active malignancy or history of treatment of any malignancy (excluding non-melanoma skin cancer) within the previous three years. – History of other malignancy which could affect the diagnosis or assessment of OSI-461. – Previous therapy for CLL. – Use of an investigational medication or device within one month of initiating study therapy. – Concurrent immunotherapy. – Use of steroids at the time of enrollment (patients who require steroids after enrollment may remain on study). – Any condition or any medication which may interfere with the conduct of the study. – Serious uncontrolled intercurrent medical or psychiatric illness, including serious infection. – Evidence of CNS involvement. – Pregnant or nursing women.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Astellas Pharma Inc
  • Collaborator
    • OSI Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor

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