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NCT00703300 · ClinicalTrials.gov registry record · Phase 1
Decitabine and Bortezomib in Treating Patients With Acute Myeloid Leukemia
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT00703300: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00703300 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 19 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00703300, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
Study Summary
This phase I trial is studying the side effects and best dose of bortezomib when given together with decitabine in treating patients with acute myeloid leukemia. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with decitabine may kill more cancer cells.
Primary Outcome
If a patient meets the definition of dose-limiting toxicity (DLT), the patient may continue on with study therapy provided that the toxicity can be managed according to the dose modification guidelines. For DLT = 2, dose level will stop. This dose level will be declared the MTD administered dose (highest dose administered). As an exploratory, phase I study, no inferential statistical tests of hypotheses are planned. Data collected will be descriptive and provide limited estimates of variability
Interventions
- OTHER laboratory biomarker analysis
- OTHER pharmacological study
- DRUG decitabine
- DRUG bortezomib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2008-06 |
| Est. Completion | 2014-10 |
| Phase | Phase 1 |
What the finished NCT00703300 record still lists
NCT00703300 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 4 interventions - of which laboratory biomarker analysis is the first listed.
NCT00703300 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00703300 about?
NCT00703300 is a clinical study titled "Decitabine and Bortezomib in Treating Patients With Acute Myeloid Leukemia". This phase I trial is studying the side effects and best dose of bortezomib when given together with decitabine in treating patients with acute myeloid leukemia. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as...
What is the current status of trial NCT00703300?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2008-06. Estimated completion is 2014-10.
What interventions are being tested in trial NCT00703300?
The interventions under investigation include: laboratory biomarker analysis (OTHER), pharmacological study (OTHER), decitabine (DRUG), bortezomib (DRUG).
Who is sponsoring clinical trial NCT00703300?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00703300's enrollment target sits among peer trials
19 1716th of 2000 higher than 281 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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