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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01358019
First Posted: May 23, 2011
Last Update Posted: January 28, 2013
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.
Information provided by (Responsible Party):
Kyowa Hakko Kirin Co., Ltd
  Purpose
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 Intervention Phase
Solid Tumors Drug: LY2523355 Phase 1

Study Type: Interventional
Study Design: 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

Further study details as provided by Kyowa Hakko Kirin Co., Ltd:

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

Secondary Outcome Measures:
  • Pharmacokinetics
    Plasma concentration of LY2523355 and metabolite

  • Antitumor effect
    Response evaluation criteria in solid tumors


Enrollment: 18
Study Start Date: May 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY2523355 Drug: LY2523355
Days 1, 2, and 3 in a cycle that consists of 21-days

  Eligibility

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.


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

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


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kyowa Hakko Kirin Co., Ltd
ClinicalTrials.gov Identifier: NCT01358019     History of Changes
Other Study ID Numbers: 2523355-001
First Submitted: May 17, 2011
First Posted: May 23, 2011
Last Update Posted: January 28, 2013
Last Verified: January 2013