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NCT01437007 · ClinicalTrials.gov registry record · Phase 1
TKM 080301 for Primary or Secondary Liver Cancer
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
NCT01437007: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01437007 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 1 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01437007, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
Study Summary
Background: Cancer in the liver can start in the liver (e.g., primary liver cancer or hepatocellular cancer) or spread to the liver from cancers in other parts of the body (e.g. colon, pancreas, gastric, breast, ovarian, esophageal cancers, cancer with metastases to the liver.) People who have tumors that can be removed by surgery live longer than those whose cancer cannot be removed. Chemotherapy can shrink some tumors in the liver, which also helps people to live longer, and sometimes chemotherapy can shrink tumors enough that they can be removed by surgery. However, most chemotherapy drugs do not work well on tumors in the liver. In this study we are testing a new drug, TKM-080301, given directly into the cancer blood supply in the liver circulation, to see if it will cause tumors to shrink. Objectives: \- To test the safety and effectiveness of TKM-080301 for cancer in the liver that has not responded to standard treatments. Eligibility: \- Individuals at least 18 years of age who have inoperable cancer that has started in or spread to the liver. Design: * Participants will be screened with a medical history and physical exam. They will also have blood tests, and imaging studies. * Participants will have a liver angiogram (type of X-ray study) to look at the blood flow in the liver and to place a catheter for delivery of the TKM080301. * Participants will have a single dose of TKM-080301 given directly into the liver. After the drug has been given, the catheter will be removed. They will have frequent blood tests and keep a diary to record side effects. * Participants may have two more doses, each dose given 2 weeks apart. {Before each dose, participants will have another angiogram and catheter placement.}They may also have liver biopsies to study the tumors. * Two weeks after the third treatment (one full course), participants will have a physical exam, blood tests, and imaging studies. If the tumor is shrinking, they may have up to three more courses of
Interventions
- DRUG TKM-080301
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2011-08-26 |
| Est. Completion | 2012-06-21 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01437007
The ClinicalTrials.gov registry entry for NCT01437007 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which TKM-080301 is the first listed.
NCT01437007 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01437007 about?
NCT01437007 is a clinical study titled "TKM 080301 for Primary or Secondary Liver Cancer". Background: Cancer in the liver can start in the liver (e.g., primary liver cancer or hepatocellular cancer) or spread to the liver from cancers in other parts of the body (e.g. colon, pancreas, gastric, breast, ovarian, esophageal cancers, cancer with metastases to the liver.) People who have tumo...
What is the current status of trial NCT01437007?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2011-08-26. Estimated completion is 2012-06-21.
What interventions are being tested in trial NCT01437007?
The interventions under investigation include: TKM-080301 (DRUG).
Who is sponsoring clinical trial NCT01437007?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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