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NCT00107536 · ClinicalTrials.gov registry record · Phase 2
Lapatinib Ditosylate in Treating Patients With Unresectable Liver or Biliary Tract Cancer
A Phase 2 study of Advanced Adult Primary Liver Cancer and Localized Unresectable Adult Primary Liver Cancer, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 26
- Enrollment target
- 1
- Study location
NCT00107536: Completed Phase 2 study of Advanced Adult Primary Liver Cancer and Localized Unresectable Adult Primary Liver Cancer, sponsored by National Cancer Institute (NCI).
NCT00107536 is a Phase 2 study of Advanced Adult Primary Liver Cancer and Localized Unresectable Adult Primary Liver Cancer that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 26 participants, roughly in line with the 26-participant average among 7 other Advanced Adult Primary Liver Cancer trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00107536, a Phase 2 study of Advanced Adult Primary Liver Cancer and Localized Unresectable Adult Primary Liver Cancer, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 26 participants
- Enrollment target
- 1
- Study location
Study Summary
Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This phase II trial is studying how well lapatinib ditosylate works in treating patients with unresectable liver or biliary tract cancer
Primary Outcome
PR (Partial Response) definded as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. CR (Complete Response) is defined as the disappearance of all target lesions.
Conditions Studied
Interventions
- OTHER laboratory biomarker analysis
- DRUG lapatinib ditosylate
Study Locations (1)
Ohio
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2005-10 |
| Est. Completion | 2009-05 |
| Phase | Phase 2 |
What the finished NCT00107536 record still lists
NCT00107536 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, roughly in line with the 26-participant average among 7 other Advanced Adult Primary Liver Cancer trials with a reported enrollment target.
The record links to 8 conditions, with Advanced Adult Primary Liver Cancer appearing as the primary indexed condition, and to 2 interventions - of which laboratory biomarker analysis is the first listed.
NCT00107536 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT00107536 about?
NCT00107536 is a clinical study titled "Lapatinib Ditosylate in Treating Patients With Unresectable Liver or Biliary Tract Cancer". Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This phase II trial is studying how well lapatinib ditosylate works in treating patients with unresectable liver or biliary tract cancer
What is the current status of trial NCT00107536?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2005-10. Estimated completion is 2009-05.
What conditions does trial NCT00107536 study?
This clinical trial studies the following conditions: Advanced Adult Primary Liver Cancer, Localized Unresectable Adult Primary Liver Cancer, Recurrent Adult Primary Liver Cancer, Adult Primary Hepatocellular Carcinoma, Recurrent Extrahepatic Bile Duct Cancer.
What interventions are being tested in trial NCT00107536?
The interventions under investigation include: laboratory biomarker analysis (OTHER), lapatinib ditosylate (DRUG).
Who is sponsoring clinical trial NCT00107536?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00107536 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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