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NCT00958022 · ClinicalTrials.gov registry record · Phase 1
Carboplatin and Etoposide Plus LBH589 for Small Cell Lung Cancer
A Phase 1 study, sponsored by Ahmad Tarhini.
- Terminated
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
NCT00958022 is a Phase 1 study that was terminated before completion, run by Ahmad Tarhini. The registered enrollment target is 7 participants.
The verdict
NCT00958022, a Phase 1 study, was terminated before completion, sponsored by Ahmad Tarhini.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
Study Summary
The subjects are being asked to take part in the Phase I or Phase II portion of a research study of a new investigational drug, LBH589, in combination with chemotherapeutic agents, carboplatin with etoposide. LBH589 (made by Novartis Pharmaceuticals Corp.) is considered "investigational" because it has not been approved for commercial use in the treatment of cancer by the U.S. Food and Drug Administration (FDA). Etoposide and carboplatin are chemotherapeutic agents approved by the FDA for the treatment of for small cell lung cancer. LBH589 is a drug that may slow down the growth of cancer cells or kill cancer cells by blocking certain enzymes (proteins produced by cells). LBH589 has shown effects against cancer in laboratory studies and in studies using animals; however, it is not known if this medicine will show the same activity in humans. As of May 2006, approximately 100 patients have received treatment with either an intravenous or capsule form of LBH589. Only the capsule form of LBH589 will be used in this study. The main goal during the Phase I portion of this research study is to find out the highest and safest dose of LBH589 that can be given in combination with carboplatin with etoposide in subjects with lung cancer without causing severe side effects. The main goal of the Phase II portion of this study is to find how the subject's lung cancer responds to the LBH589 in combination with carboplatin and etoposide at the highest and safest dose that was given in Phase I. The subject may be enrolled in either Phase I or Phase II of the trial, depending on when they entered the study, but they will not be enrolled in both phases. This study will also investigate how the subject's body processes the combination of LBH589 and carboplatin with etoposide. To determine this, the investigators will measure the amount of study drug in the subject's blood. This will be done with a series of blood tests, called pharmacokinetic (PK) tests. Pharmacokinetics is the stu
Interventions
- DRUG LBH589 and carboplatin with etoposide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2009-09 |
| Est. Completion | 2011-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00958022
The ClinicalTrials.gov registry entry for NCT00958022 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ahmad Tarhini, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which LBH589 and carboplatin with etoposide is the first listed.
NCT00958022 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00958022 about?
NCT00958022 is a clinical study titled "Carboplatin and Etoposide Plus LBH589 for Small Cell Lung Cancer". The subjects are being asked to take part in the Phase I or Phase II portion of a research study of a new investigational drug, LBH589, in combination with chemotherapeutic agents, carboplatin with etoposide. LBH589 (made by Novartis Pharmaceuticals Corp.) is considered "investigational" because it ...
What is the current status of trial NCT00958022?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2009-09. Estimated completion is 2011-06.
What interventions are being tested in trial NCT00958022?
The interventions under investigation include: LBH589 and carboplatin with etoposide (DRUG).
Who is sponsoring clinical trial NCT00958022?
This trial is sponsored by Ahmad Tarhini, which has 6 total clinical trials registered on ClinicalTrials.gov.
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