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NCT01304602 · ClinicalTrials.gov registry record · Phase 1
A Trial of Irinotecan and BKM120 in Previously Treated Advanced Colorectal Cancer
A Phase 1 study, sponsored by University of Kansas Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT01304602: Completed Phase 1 study, sponsored by University of Kansas Medical Center.
NCT01304602 is a Phase 1 study that has completed, run by University of Kansas Medical Center. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01304602, a Phase 1 study, has completed, sponsored by University of Kansas Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
This phase I trial will use the combination of irinotecan and BKM120 in patients with advanced colorectal cancer who have failed on or have become intolerant of at least one line of therapy for advanced colorectal cancer and who are candidates for irinotecan therapy.
Primary Outcome
The maximum tolerated dose will be defined as the dose level prior to the dose level in which dose-escalation was stopped based on dose-limiting toxicities (DLTs). DLTs are based on specific adverse events specified in the study protocol. DLTs will be assessed during the first two cycles of treatment (28 days total).
Interventions
- DRUG Irinotecan
- DRUG BKM120
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2011-02 |
| Est. Completion | 2015-10 |
| Phase | Phase 1 |
What the finished NCT01304602 record still lists
NCT01304602 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 2 interventions - of which Irinotecan is the first listed.
NCT01304602 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01304602 about?
NCT01304602 is a clinical study titled "A Trial of Irinotecan and BKM120 in Previously Treated Advanced Colorectal Cancer". This phase I trial will use the combination of irinotecan and BKM120 in patients with advanced colorectal cancer who have failed on or have become intolerant of at least one line of therapy for advanced colorectal cancer and who are candidates for irinotecan therapy.
What is the current status of trial NCT01304602?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2011-02. Estimated completion is 2015-10.
What interventions are being tested in trial NCT01304602?
The interventions under investigation include: Irinotecan (DRUG), BKM120 (DRUG).
Who is sponsoring clinical trial NCT01304602?
This trial is sponsored by University of Kansas Medical Center, which has 408 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01304602's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 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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