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NCT00943943 · ClinicalTrials.gov registry record · Phase 1
Granulocyte-colony Stimulating Factor (G-CSF) and Plerixafor Plus Sorafenib for Acute Myelogenous Leukemia (AML) With FLT3 Mutations
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 33
- Enrollment target
NCT00943943: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT00943943 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 33 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00943943, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 33 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to learn the most tolerable dose of Nexavarâ (sorafenib) when given in combination with Mobozilâ (plerixafor) and Neupogenâ (filgrastim) to patients with AML. The safety of this combination will also be studied. Funding Source - FDA OOPD
Primary Outcome
MTD dose level of Sorafenib where less than two participants (2/3) experience Dose limiting toxicity (DLT), based on Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, is defined as ± Grade 3 nonhematological toxicity or nausea/vomiting (in the absence of appropriate antiemetics) that cannot be explained by intercurrent conditions such as infections and at least possibly related to the combination of agents in study.
Interventions
- DRUG G-CSF
- DRUG Plerixafor
- DRUG Sorafenib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2010-10-29 |
| Est. Completion | 2017-03-23 |
| Phase | Phase 1 |
What the finished NCT00943943 record still lists
NCT00943943 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower).
The record links to 0 conditions, and to 3 interventions - of which G-CSF is the first listed.
NCT00943943 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00943943 about?
NCT00943943 is a clinical study titled "Granulocyte-colony Stimulating Factor (G-CSF) and Plerixafor Plus Sorafenib for Acute Myelogenous Leukemia (AML) With FLT3 Mutations". The goal of this clinical research study is to learn the most tolerable dose of Nexavarâ (sorafenib) when given in combination with Mobozilâ (plerixafor) and Neupogenâ (filgrastim) to patients with AML. The safety of this combination will also be studied. Funding Source - FDA OOPD
What is the current status of trial NCT00943943?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2010-10-29. Estimated completion is 2017-03-23.
What interventions are being tested in trial NCT00943943?
The interventions under investigation include: G-CSF (DRUG), Plerixafor (DRUG), Sorafenib (DRUG).
Who is sponsoring clinical trial NCT00943943?
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 NCT00943943's enrollment target sits among peer trials
33 1280th of 2000 higher than 705 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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