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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
  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:


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
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: 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 by Kyowa Hakko Kirin Company, Limited

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 November 25, 2014