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Completed

NCT Number: NCT01358019

A Study of LY2523355 in Patients With Solid Cancer

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.

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Key information

Conditions

Solid Tumors

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY2523355

Drug

Days 1, 2, and 3 in a cycle that consists of 21-days

Primary outcomes

  1. Dose limiting toxicity based on the Common Terminology Criteria for Adverse Events v4.0

  2. Number of patients with adverse events

Secondary outcomes

  1. Pharmacokinetics

    Plasma concentration of LY2523355 and metabolite

  2. Antitumor effect

    Response evaluation criteria in solid tumors

Sponsors and collaborators

Lead sponsor

Kyowa Kirin Co., Ltd.

Industry

Registry information

Official study title

A Phase 1 Study of LY2523355 in Patients With Solid Cancer

Acronym: 2523355-001

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
May 23, 2011
Registry last updated
Jan 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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