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NCT01113476 · ClinicalTrials.gov registry record · Phase 1
Nab-paclitaxel, Gemcitabine, and Bevacizumab in Advanced Malignancies
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 176
- Enrollment target
NCT01113476: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT01113476 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 176 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (193% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01113476, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 176 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to find the highest tolerable dose of the combination of Abraxane (nab-paclitaxel), Gemzar (gemcitabine), and Avastin (bevacizumab) that can be given to patients with advanced cancer. The safety of this drug combination will also be studied.
Primary Outcome
A MTD is defined as the dose level below the dose at which 2 of 6 patients experience drug-related dose limiting toxicity (DLT) in the first cycle. DLT defined as any grade 3 or 4 non-hematologic toxicity as defined in the NCI CTC v4.0, even if expected and believed related to study medications (except nausea and vomiting responsive to appropriate regimens or alopecia), any Grade 4 hematologic toxicity lasting 2 weeks or longer (as defined by the NCI-CTCAE), despite supportive care; any Grade 4
Interventions
- DRUG Bevacizumab
- DRUG Gemcitabine
- DRUG Nab-paclitaxel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 176 participants |
| Start Date | 2010-04-27 |
| Est. Completion | 2022-08-12 |
| Phase | Phase 1 |
What the finished NCT01113476 record still lists
NCT01113476 is an interventional study that assigns participants to a tested intervention. The registered 176 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (193% higher).
The record links to 0 conditions, and to 3 interventions - of which Bevacizumab is the first listed.
NCT01113476 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01113476 about?
NCT01113476 is a clinical study titled "Nab-paclitaxel, Gemcitabine, and Bevacizumab in Advanced Malignancies". The goal of this clinical research study is to find the highest tolerable dose of the combination of Abraxane (nab-paclitaxel), Gemzar (gemcitabine), and Avastin (bevacizumab) that can be given to patients with advanced cancer. The safety of this drug combination will also be studied.
What is the current status of trial NCT01113476?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 176 participants. The study started on 2010-04-27. Estimated completion is 2022-08-12.
What interventions are being tested in trial NCT01113476?
The interventions under investigation include: Bevacizumab (DRUG), Gemcitabine (DRUG), Nab-paclitaxel (DRUG).
Who is sponsoring clinical trial NCT01113476?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01113476's enrollment target sits among peer trials
176 316th of 2000 higher than 1,682 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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