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A Study of LY2523355 in Patients With Solid Cancer (2523355-001)

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ClinicalTrials.gov Identifier: NCT01358019
Recruitment Status : Completed
First Posted : May 23, 2011
Last Update Posted : January 28, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:
The primary objective of this study is to examine a recommended dose for subsequent phase trial(s), by the observation of the safety and toxicity profiles of LY2523355 in patients with advanced and/or metastatic cancer. The secondary objectives are to study the pharmacokinetics and antitumor effect.

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: LY2523355 Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of LY2523355 in Patients With Solid Cancer
Study Start Date : May 2011
Primary Completion Date : January 2013
Study Completion Date : January 2013
Arms and Interventions

Arm Intervention/treatment
Experimental: LY2523355 Drug: LY2523355
Days 1, 2, and 3 in a cycle that consists of 21-days

Outcome Measures

Primary Outcome Measures :
  1. Dose limiting toxicity based on the Common Terminology Criteria for Adverse Events v4.0
  2. Number of patients with adverse events

Secondary Outcome Measures :
  1. Pharmacokinetics
    Plasma concentration of LY2523355 and metabolite

  2. Antitumor effect
    Response evaluation criteria in solid tumors

Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Histological and/or cytological evidence of solid tumors
  • A diagnosis of advanced and/or metastatic solid tumors
  • Patients who are refractory to standard therapy or for which no proven effective therapy exists
  • Written informed consent
  • Appropriate bone marrow, hepatic and renal functions
  • ECOG PS =< 1

Exclusion Criteria:

  • Have serious preexisting complication
  • Have active infection which requires intravenous antibiotics
  • Have symptomatic central nervous system metastases
  • Have current acute or chronic leukemia
  • Have had an autologous or allogenic hematopoietic stem cell transplantation
  • Have active multiple cancers
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01358019

Tokyo, Japan
Sponsors and Collaborators
Kyowa Hakko Kirin Co., Ltd
Study Director: Senior Manager Kyowa Hakko Kirin Co., Ltd