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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: Completed Phase 1 study, sponsored by Roswell Park Cancer Institute.
NCT01540253 is a Phase 1 study that has completed, run by Roswell Park Cancer Institute. The registered enrollment target is 38 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Adverse events (AE) will be coded and evaluated for severity using NCI CTCAE, version 4.0 and will be summarized by system organ class and preferred term.
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 |
What the finished NCT01540253 record still lists
NCT01540253 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower).
The record links to 0 conditions, and to 5 interventions - of which laboratory biomarker analysis is the first listed.
NCT01540253 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01540253's enrollment target sits among peer trials
38 1197th of 2000 higher than 797 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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