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NCT01264081 · ClinicalTrials.gov registry record · Phase 2
Lapatinib in Stage IV Melanoma With ERBB4 Mutations
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 2
- Development phase
- 34
- Enrollment target
NCT01264081: Clinical Trial Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT01264081 is a Phase 2 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 34 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01264081, a Phase 2 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 34 participants
- Enrollment target
Study Summary
Background: \- Studies of melanoma tumor samples have shown that tumor cells from approximately 20 percent of melanoma patients contain a specific mutation of a gene involved in making a protein called ERBB4, and that changes in this gene have been associated with cancer. Lapatinib, a drug that is currently approved for the treatment of breast cancer, has been shown in the laboratory to significantly slow the growth of melanoma cells that contain this specific ERBB4 gene mutation. Researchers are interested in determining whether lapatinib can be effective against melanoma in individuals who have the ERBB4 mutation. Objectives: \- To evaluate the safety and effectiveness of lapatinib as a treatment for melanoma with ERBB4 mutation that has not responded to standard therapy. Eligibility: \- Individuals at least 18 years of age who have stage 4 melanoma that has not responded to standard therapy. Design: * Participants will be screened with a full physical examination and medical history, as well as tests of tumor tissue taken from previous surgeries or biopsies or from a new biopsy that will be conducted before the start of the study. Test results to determine eligibility will be available within about 2 weeks. * Participants will take four lapatinib tablets daily (two in the morning, 1 hour before or after breakfast and two in the evening, 1 hour before or after dinner) during every 28-day cycle of treatment. Participants will keep a medication diary to record tablets taken and any side effects from the medication. * After the first 2 weeks, and every 2 to 4 weeks afterward for the first 12 weeks, participants will have clinic visits with blood samples and other tests to determine if lapatinib is causing their disease to shrink or be controlled. If the disease has not progressed, participants will continue to receive a new lapatinib supply every 28 days for up to 2 years (27 cycles), and will continue to have regular clinic visits to monitor the progress of t
Interventions
- DRUG Lapatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2011-05-20 |
| Est. Completion | 2013-11-22 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01264081
The ClinicalTrials.gov registry entry for NCT01264081 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 34 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 Lapatinib is the first listed.
NCT01264081 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01264081 about?
NCT01264081 is a clinical study titled "Lapatinib in Stage IV Melanoma With ERBB4 Mutations". Background: \- Studies of melanoma tumor samples have shown that tumor cells from approximately 20 percent of melanoma patients contain a specific mutation of a gene involved in making a protein called ERBB4, and that changes in this gene have been associated with cancer. Lapatinib, a drug that is ...
What is the current status of trial NCT01264081?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2011-05-20. Estimated completion is 2013-11-22.
What interventions are being tested in trial NCT01264081?
The interventions under investigation include: Lapatinib (DRUG).
Who is sponsoring clinical trial NCT01264081?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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