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NCT01454076 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics Study of Oral IXAZOMIB in Participants With Advanced Nonhematologic Malignancies or Lymphoma
A Phase 1 study, sponsored by Millennium Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 112
- Enrollment target
NCT01454076: Completed Phase 1 study, sponsored by Millennium Pharmaceuticals.
NCT01454076 is a Phase 1 study that has completed, run by Millennium Pharmaceuticals. The registered enrollment target is 112 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01454076, a Phase 1 study, has completed, sponsored by Millennium Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 112 participants
- Enrollment target
Study Summary
This is an open-label, multicenter, sequential, 5-arm, phase 1 study of oral IXAZOMIB designed to assess drug-drug interaction with ketoconazole (Arm 1), the relative bioavailability of 2 capsule formulations of IXAZOMIB (Arm 2), food effect (Arm 3), drug-drug interaction with rifampin (Arm 4), and drug-drug interaction with clarithromycin (Arm 5) in participants with advanced nonhematologic malignancies or lymphoma.
Interventions
- DRUG Rifampin
- DRUG Ketoconazole
- DRUG Ixazomib 2.5 mg
- DRUG Ixazomib 4 mg Capsule A
- DRUG Ixazomib 4 mg Capsule B
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2011-11-10 |
| Est. Completion | 2016-06-16 |
| Phase | Phase 1 |
What the finished NCT01454076 record still lists
NCT01454076 is an interventional study that assigns participants to a tested intervention. The registered 112 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 (87% higher).
The record links to 0 conditions, and to 5 interventions - of which Rifampin is the first listed.
NCT01454076 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01454076 about?
NCT01454076 is a clinical study titled "Pharmacokinetics Study of Oral IXAZOMIB in Participants With Advanced Nonhematologic Malignancies or Lymphoma". This is an open-label, multicenter, sequential, 5-arm, phase 1 study of oral IXAZOMIB designed to assess drug-drug interaction with ketoconazole (Arm 1), the relative bioavailability of 2 capsule formulations of IXAZOMIB (Arm 2), food effect (Arm 3), drug-drug interaction with rifampin (Arm 4), and ...
What is the current status of trial NCT01454076?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 112 participants. The study started on 2011-11-10. Estimated completion is 2016-06-16.
What interventions are being tested in trial NCT01454076?
The interventions under investigation include: Rifampin (DRUG), Ketoconazole (DRUG), Ixazomib 2.5 mg (DRUG), Ixazomib 4 mg Capsule A (DRUG), Ixazomib 4 mg Capsule B (DRUG).
Who is sponsoring clinical trial NCT01454076?
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 NCT01454076's enrollment target sits among peer trials
112 508th of 2000 higher than 1,489 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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