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NCT01540253 · ClinicalTrials.gov registry record · Phase 1
PI3K Inhibitor BKM120 and Docetaxel in Treating Patients With Advanced Solid Tumor That is Locally Advanced, Cannot Be Removed By Surgery, or Metastatic
A Phase 1 study, sponsored by Roswell Park Cancer Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 38
- Enrollment target
NCT01540253 is a Phase 1 study that has completed, run by Roswell Park Cancer Institute. The registered enrollment target is 38 participants.
The verdict
NCT01540253, a Phase 1 study, has completed, sponsored by Roswell Park Cancer Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 38 participants
- Enrollment target
Study Summary
This phase I trial studies the side effects and best dose of PI3K inhibitor BKM120 when given together with docetaxel in treating patients with advanced solid tumor that is locally advanced, cannot be removed by surgery, or metastatic. PI3K inhibitor BKM120 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving PI3K inhibitor BKM120 together with docetaxel may kill more tumor cells.
Interventions
- OTHER laboratory biomarker analysis
- OTHER questionnaire administration
- DRUG docetaxel
- OTHER pharmacological study
- DRUG PI3K inhibitor BKM120
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2012-05 |
| Est. Completion | 2016-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01540253
The ClinicalTrials.gov registry entry for NCT01540253 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Roswell Park Cancer Institute, which has 365 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which laboratory biomarker analysis is the first listed.
NCT01540253 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01540253 about?
NCT01540253 is a clinical study titled "PI3K Inhibitor BKM120 and Docetaxel in Treating Patients With Advanced Solid Tumor That is Locally Advanced, Cannot Be Removed By Surgery, or Metastatic". This phase I trial studies the side effects and best dose of PI3K inhibitor BKM120 when given together with docetaxel in treating patients with advanced solid tumor that is locally advanced, cannot be removed by surgery, or metastatic. PI3K inhibitor BKM120 may stop the growth of tumor cells by bloc...
What is the current status of trial NCT01540253?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2012-05. Estimated completion is 2016-06.
What interventions are being tested in trial NCT01540253?
The interventions under investigation include: laboratory biomarker analysis (OTHER), questionnaire administration (OTHER), docetaxel (DRUG), pharmacological study (OTHER), PI3K inhibitor BKM120 (DRUG).
Who is sponsoring clinical trial NCT01540253?
This trial is sponsored by Roswell Park Cancer Institute, which has 365 total clinical trials registered on ClinicalTrials.gov.
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