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NCT00830869 · ClinicalTrials.gov registry record · Phase 1
A Phase 1 Study of IXAZOMIB in Adult Patients With Advanced Nonhematologic Malignancies
A Phase 1 study, sponsored by Millennium Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 116
- Enrollment target
NCT00830869: Completed Phase 1 study, sponsored by Millennium Pharmaceuticals.
NCT00830869 is a Phase 1 study that has completed, run by Millennium Pharmaceuticals. The registered enrollment target is 116 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00830869, a Phase 1 study, has completed, sponsored by Millennium Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 116 participants
- Enrollment target
Study Summary
This is an open-label, multicenter, phase 1, dose escalation study of IXAZOMIB. The primary purpose of this study is to determine the safety profile, establish the maximum tolerated dose, and inform the phase 2 dose of IXAZOMIB administered intravenously in participants with nonhematologic malignancies.
Primary Outcome
Toxicity according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. DLT is any of following related to ixazomib:Grade (GR) 4 neutropenia (absolute neutrophil count\<500 cells/cubic meter\[cells/mm\^3\])for\>7 days; GR 3 neutropenia with coincident fever and/or infection; GR 4 thrombocytopenia (platelets \<25,000 cells/mm3)for\>7 days; GR 3 thrombocytopenia with clinically significant bleeding; Platelet count\<10,000 cells/mm3; GR 3 peripheral
Interventions
- DRUG IXAZOMIB
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 116 participants |
| Start Date | 2009-03-02 |
| Est. Completion | 2012-04-20 |
| Phase | Phase 1 |
What the finished NCT00830869 record still lists
NCT00830869 is an interventional study that assigns participants to a tested intervention. The registered 116 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 (93% higher).
The record links to 0 conditions, and to 1 intervention - of which IXAZOMIB is the first listed.
NCT00830869 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00830869 about?
NCT00830869 is a clinical study titled "A Phase 1 Study of IXAZOMIB in Adult Patients With Advanced Nonhematologic Malignancies". This is an open-label, multicenter, phase 1, dose escalation study of IXAZOMIB. The primary purpose of this study is to determine the safety profile, establish the maximum tolerated dose, and inform the phase 2 dose of IXAZOMIB administered intravenously in participants with nonhematologic malignanc...
What is the current status of trial NCT00830869?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 116 participants. The study started on 2009-03-02. Estimated completion is 2012-04-20.
What interventions are being tested in trial NCT00830869?
The interventions under investigation include: IXAZOMIB (DRUG).
Who is sponsoring clinical trial NCT00830869?
This trial is sponsored by Millennium Pharmaceuticals, which has 135 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00830869's enrollment target sits among peer trials
116 501st of 2000 higher than 1,497 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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