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NCT00966914 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Study of Tavocept Versus Placebo in Patients With Newly Diagnosed or Relapsed Advanced Primary Adenocarcinoma of the Lung Treated With Docetaxel or Paclitaxel Plus Cisplatin
A Phase 3 study, sponsored by BioNumerik Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 540
- Enrollment target
NCT00966914 is a Phase 3 study that has completed, run by BioNumerik Pharmaceuticals. The registered enrollment target is 540 participants.
The verdict
NCT00966914, a Phase 3 study, has completed, sponsored by BioNumerik Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 540 participants
- Enrollment target
Study Summary
Tavocept is an investigational drug that is being developed to see if it can increase the survival of patients who are being treated with chemotherapy as well as to see if it can prevent or reduce side effects of chemotherapy. This research study is aimed at trying to find out if people with advanced adenocarcinoma of the lung who are treated with a standard combination of chemotherapy drugs will live longer if they are also treated with an investigational drug called "Tavocept." Another objective of this research study is to find out whether or not Tavocept helps to prevent or reduce side-effects like kidney damage, anemia, and nausea and vomiting that can occur with these drug combinations. The drug combinations that will be used in this research study will include either paclitaxel and cisplatin, or docetaxel and cisplatin. These drug combinations are approved to be used to treat people with advanced NSCLC. Every patient on this research study will be treated with standard chemotherapy for primary NSCLC in the form of either docetaxel or paclitaxel (these will be recommended by your research study doctor), which will be given in combination with cisplatin.
Interventions
- DRUG Tavocept(BNP7787) in combination with cisplatin and either docetaxel or paclitaxel
- DRUG Placebo in combination with cisplatin and docetaxel or paclitaxel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 540 participants |
| Start Date | 2010-04 |
| Est. Completion | 2013-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00966914
The ClinicalTrials.gov registry entry for NCT00966914 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 540 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioNumerik Pharmaceuticals, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Tavocept(BNP7787) in combination with cisplatin and either docetaxel or paclitaxel is the first listed.
NCT00966914 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00966914 about?
NCT00966914 is a clinical study titled "Phase 3 Study of Tavocept Versus Placebo in Patients With Newly Diagnosed or Relapsed Advanced Primary Adenocarcinoma of the Lung Treated With Docetaxel or Paclitaxel Plus Cisplatin". Tavocept is an investigational drug that is being developed to see if it can increase the survival of patients who are being treated with chemotherapy as well as to see if it can prevent or reduce side effects of chemotherapy. This research study is aimed at trying to find out if people with advance...
What is the current status of trial NCT00966914?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 540 participants. The study started on 2010-04. Estimated completion is 2013-06.
What interventions are being tested in trial NCT00966914?
The interventions under investigation include: Tavocept(BNP7787) in combination with cisplatin and either docetaxel or paclitaxel (DRUG), Placebo in combination with cisplatin and docetaxel or paclitaxel (DRUG).
Who is sponsoring clinical trial NCT00966914?
This trial is sponsored by BioNumerik Pharmaceuticals, which has 4 total clinical trials registered on ClinicalTrials.gov.
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