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A Study of LY2181308 in Patients With Advanced Hepatocellular Carcinoma

This study has been withdrawn prior to enrollment.
(Trial cancelled)
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00415155
First received: December 20, 2006
Last updated: August 27, 2008
Last verified: August 2008
December 20, 2006
August 27, 2008
August 2008
January 2011   (Final data collection date for primary outcome measure)
  • Phase 1: Determine recommended dose [ Time Frame: every cycle ]
  • Phase 2: Time to progression [ Time Frame: baseline to measured progressive disease ]
  • The recommended dose of LY2181308 in the advanced hepatocellular cancer (HCC) population
  • Time to progression for patients with advanced HCC who have received LY2181308
Complete list of historical versions of study NCT00415155 on ClinicalTrials.gov Archive Site
  • Phase 1: Safety [ Time Frame: every cycle ]
  • Phase 2: Overall Survival [ Time Frame: Baseline to date of death from any cause ]
  • Phase 2: Response rate [ Time Frame: Baseline to measured PD ]
  • Phase 2: Pharmacokinetics [ Time Frame: Cycle 1 and Cycle 2 ]
  • Phase 2: Safety [ Time Frame: every cycle ]
  • Overall survival time, progression-free survival, and time to progression of cancer symptoms
  • Safety
  • Response rate
  • Pharmacokinetics
  • Effect on circulating tumor cells and survivin expression
Not Provided
Not Provided
 
A Study of LY2181308 in Patients With Advanced Hepatocellular Carcinoma
An Open Label, Single Arm, Phase 1b/2 Study With Pharmacokinetic Sampling to Evaluate LY2181308 in Patients With Advanced Hepatocellular Carcinoma
The primary objective of this study is to estimate the time to progressive disease for patients with advanced hepatocellular cancer who receive LY2181308.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hepatocellular Carcinoma
Drug: LY2181308

Phase 1: 250mg, IV, loading dose days 1-3 cycle 1 then weekly for six 28 day cycle. (dose escalation)

Phase 2: phase 1 recommended dose, maximum 750mg dose, IV, loading dose days 1-3 cycle 1 then weekly for six 28 day cycle.

Experimental: A
Intervention: Drug: LY2181308
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
60
January 2011
January 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosed with hepatocellular cancer
  • Discontinued all previous therapies
  • At least 18 years of age

Exclusion Criteria:

  • Have other treatment options that are potentially curative or effective--such as surgical resection, liver transplant or percutaneous ablation, and/or transcatheter arterial embolization.
  • Transplanted liver
  • HIV positive
  • More than 2 previous systemic chemotherapy treatments
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France,   Germany,   Spain,   United States
 
 
NCT00415155
10460
H8Z-MC-JACS
Not Provided
Not Provided
Not Provided
Chief Medical Officer, Eli Lilly
Eli Lilly and Company
Not Provided
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP