A Study of LY2181308 in Patients With Advanced Hepatocellular Carcinoma
This study has been withdrawn prior to enrollment.
(Trial cancelled)
Sponsor:
Eli Lilly and Company
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The primary objective of this study is to estimate the time to progressive disease for patients with advanced hepatocellular cancer who receive LY2181308.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatocellular Carcinoma |
Drug: LY2181308 |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open Label, Single Arm, Phase 1b/2 Study With Pharmacokinetic Sampling to Evaluate LY2181308 in Patients With Advanced Hepatocellular Carcinoma |
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- Phase 1: Determine recommended dose [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]
- Phase 2: Time to progression [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Phase 1: Safety [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]
- Phase 2: Overall Survival [ Time Frame: Baseline to date of death from any cause ] [ Designated as safety issue: Yes ]
- Phase 2: Response rate [ Time Frame: Baseline to measured PD ] [ Designated as safety issue: No ]
- Phase 2: Pharmacokinetics [ Time Frame: Cycle 1 and Cycle 2 ] [ Designated as safety issue: No ]
- Phase 2: Safety [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 60 |
| Study Start Date: | August 2008 |
| Estimated Study Completion Date: | January 2011 |
| Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
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. |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00415155
Locations
| United States, California | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Los Angeles, California, United States, 90089 | |
| United States, Connecticut | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Hartford, Connecticut, United States, 06105 | |
| United States, New Mexico | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Albuquerque, New Mexico, United States, 87131 | |
| United States, New York | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Stony Brook, New York, United States, 11794 | |
| France | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Bondy, France, 93143 | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Clichy, France, 92118 | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Paris, France, 75015 | |
| Germany | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Berlin, Germany, 13353 | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Hannover, Germany, 30625 | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Mannheim, Germany, 68167 | |
| Spain | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Barcelona, Spain, 08036 | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Pamplona, Spain, 00000 | |
Sponsors and Collaborators
Eli Lilly and Company
Investigators
| 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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | Chief Medical Officer, Eli Lilly |
| ClinicalTrials.gov Identifier: | NCT00415155 History of Changes |
| Other Study ID Numbers: | 10460, H8Z-MC-JACS |
| Study First Received: | December 20, 2006 |
| Last Updated: | August 27, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma |
Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases |
ClinicalTrials.gov processed this record on May 22, 2013