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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier:
NCT01358019
First received: May 17, 2011
Last updated: January 25, 2013
Last verified: January 2013
History of Changes
  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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Study of LY2523355 in Patients With Solid Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Kyowa Hakko Kirin Company, Limited:

Primary Outcome Measures:
  • Dose limiting toxicity based on the Common Terminology Criteria for Adverse Events v4.0 [ Designated as safety issue: Yes ]
  • Number of patients with adverse events [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics [ Designated as safety issue: No ]
    Plasma concentration of LY2523355 and metabolite

  • Antitumor effect [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01358019

Locations
Japan
Tokyo, Japan
Sponsors and Collaborators
Kyowa Hakko Kirin Company, Limited
Investigators
Study Director: Senior Manager Kyowa Hakko Kirin
  More Information

No publications provided

Responsible Party: Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier: NCT01358019     History of Changes
Other Study ID Numbers: 2523355-001
Study First Received: May 17, 2011
Last Updated: January 25, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

ClinicalTrials.gov processed this record on May 23, 2013