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NCT01497626 · ClinicalTrials.gov registry record · Phase 1
Lapatinib and Bortezomib in Patients With Advanced Malignancies
A Phase 1 study, sponsored by Georgetown University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT01497626 is a Phase 1 study that was terminated before completion, run by Georgetown University. The registered enrollment target is 15 participants.
The verdict
NCT01497626, a Phase 1 study, was terminated before completion, sponsored by Georgetown University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
This study is for patients with an advanced type of cancer for which no curative treatment exists. The purpose of this study is to test the safety and efficacy of the combination of the study drugs, lapatinib and bortezomib. Lapatinib is a drug that targets two proteins important for the growth of cancer cells known as HER1 (EGFR) and HER2. By inhibiting these proteins, lapatinib can inhibit cancer cell growth and even lead to their death. Lapatinib is an oral pill given by mouth once every day. Lapatinib is approved by the FDA for patients with breast cancer. Bortezomib is a drug that targets a part of cancer cells known as the proteosome. By inhibiting the proteosome, bortezomib can inhibit cancer cell growth and even lead to their death. Bortezomib is given intravenously, once a week, 2 out of every 3 weeks. Bortezomib is approved by the FDA for patients with multiple myeloma and mantle cell lymphoma. This research is being done because it is not known if the combination of lapatinib and bortezomib will work better than lapatinib or bortezomib alone, although in the lab and in animal studies the combination of the two drugs was much more effective than either drug alone. As part of this study biopsies will be taken of patients' tumors before any treatment, after starting lapatinib alone, and after receiving both lapatinib and bortezomib. Investigators want to study what markers inside tumors may relate to how well these two medications work. These biopsies are required as part of the study.
Interventions
- DRUG Lapatinib and bortezomib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2011-09 |
| Est. Completion | 2015-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01497626
The ClinicalTrials.gov registry entry for NCT01497626 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Georgetown University, which has 227 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Lapatinib and bortezomib is the first listed.
NCT01497626 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01497626 about?
NCT01497626 is a clinical study titled "Lapatinib and Bortezomib in Patients With Advanced Malignancies". This study is for patients with an advanced type of cancer for which no curative treatment exists. The purpose of this study is to test the safety and efficacy of the combination of the study drugs, lapatinib and bortezomib. Lapatinib is a drug that targets two proteins important for the growth of ...
What is the current status of trial NCT01497626?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2011-09. Estimated completion is 2015-12.
What interventions are being tested in trial NCT01497626?
The interventions under investigation include: Lapatinib and bortezomib (DRUG).
Who is sponsoring clinical trial NCT01497626?
This trial is sponsored by Georgetown University, which has 227 total clinical trials registered on ClinicalTrials.gov.
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