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NCT01571024 · ClinicalTrials.gov registry record · Phase 1
BKM120 + mFOLFOX6 in Advanced Solid Tumors With Expansion Cohort Pancreatic Cancer
A Phase 1 study, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT01571024: Completed Phase 1 study, sponsored by UNC Lineberger Comprehensive Cancer Center.
NCT01571024 is a Phase 1 study that has completed, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 17 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01571024, a Phase 1 study, has completed, sponsored by UNC Lineberger Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
Study Summary
The purpose of this study is to establish the safety and tolerability of BKM120 when combined with mFOLFOX6 and to define the maximum tolerated dose of BKM120 in this combination in advanced solid tumors including metastatic pancreatic cancer.
Primary Outcome
A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications, and occurs within the first cycle of therapy (4 weeks)of BKM120 when administered with mFOLFOX6 in patients with advanced solid tumors including metastatic pancreatic cancer.
Interventions
- DRUG mFOLFOX6
- DRUG BKM120
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2012-05 |
| Est. Completion | 2016-03 |
| Phase | Phase 1 |
What the finished NCT01571024 record still lists
NCT01571024 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 2 interventions - of which mFOLFOX6 is the first listed.
NCT01571024 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01571024 about?
NCT01571024 is a clinical study titled "BKM120 + mFOLFOX6 in Advanced Solid Tumors With Expansion Cohort Pancreatic Cancer". The purpose of this study is to establish the safety and tolerability of BKM120 when combined with mFOLFOX6 and to define the maximum tolerated dose of BKM120 in this combination in advanced solid tumors including metastatic pancreatic cancer.
What is the current status of trial NCT01571024?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2012-05. Estimated completion is 2016-03.
What interventions are being tested in trial NCT01571024?
The interventions under investigation include: mFOLFOX6 (DRUG), BKM120 (DRUG).
Who is sponsoring clinical trial NCT01571024?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01571024's enrollment target sits among peer trials
17 1785th of 2000 higher than 215 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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